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Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A 6-Month Analysis

Open access
Tillman, John B, Beck, Roy W, Polonsky, William H, Calhoun, Peter, Mouse, Thomas, Bailey, Ryan, Jacoby, Jeanne, Nandan, Rakesh +2 more·2025·The Journal of Clinical Endocrinology & Metabolism
DOI 10.1210/clinem/dgae778PMC PMC12261103
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Abstract

Context: The Bigfoot Unity Diabetes Management System integrates Abbott FreeStyle Libre 2 continuous glucose monitoring (CGM) data into a smart insulin pen cap and mobile app, enabling clinician-directed insulin dose recommendations and real-time alerts. Objective: The objective was to analyze real-world 6-month glycemic control in a prospective study for individuals using the System for multiple daily insulin injections (MDI). Methods: We conducted a 6-month analysis from the BURST study (NCT05088265) of individuals with type 1 or type 2 diabetes (T2D). Participants reported baseline demographics, adverse events, and other survey data electronically. Either at-home kit or electronic medical record glycated hemoglobin A1c (HbA1c) data were collected. Results: Of 102 participants in the per protocol cohort, median age was 59 years, 87% had T2D, 42% used CGM previously, 62% were White non-Hispanic, and 59% female. Mean HbA1c decreased from 9.1 ± 1.7% at baseline to 8.0 ± 1.2% at 6 months (mean difference −1.1%, 95% CI −1.4 to −0.8, P < .001). At 6 months, time in range (70-180 mg/dL), time at < 70 mg/dL, and time at < 54 mg/dL were 56 ± 23%, 1.0 ± 1.4%, and 0.04 ± 0.14%, respectively. Six severe hypoglycemia events occurred in 4 participants (none System-related) and no diabetic ketoacidosis events occurred in the per protocol cohort. Conclusion: In this study primarily of older adults with T2D using MDI, durable glycemic improvement occurred using the System at 6 months, with the frequency of hypoglycemia being substantially below established targets of < 4% and < 1% for time below 70 and 54 mg/dL, respectively.

AI snapshot

Written from the paper’s full text.

TL;DR

In a prospective, single-arm 6-month analysis of the Bigfoot Unity Diabetes Management System in adults using multiple daily insulin injections, mean HbA1c fell from 9.1% to 8.0% in the per protocol cohort. Glycemic improvement was accompanied by low rates of hypoglycemia and significant improvements in diabetes distress and hypoglycemia confidence.

Key findings

  • In the per protocol cohort (N = 102), mean HbA1c decreased from 9.1 ± 1.7% at baseline to 8.0 ± 1.2% at 6 months (mean difference −1.1%, 95% CI −1.4 to −0.8, P < .001). In the expanded cohort (N = 171), mean HbA1c decreased from 9.4 ± 1.9% to 8.1 ± 1.4% (mean change −1.3%, 95% CI −1.6 to −1.0, P < .001).
  • At 6 months in the per protocol cohort, time in range (70-180 mg/dL) was 56 ± 23%, time < 70 mg/dL was 1.0 ± 1.4%, and time < 54 mg/dL was 0.04 ± 0.14%. Six severe hypoglycemia events occurred in 4 participants (none System-related), and no diabetic ketoacidosis events occurred in the per protocol cohort.
  • Patient-reported outcomes improved: mean T1-DDS total score fell from 2.4 ± 0.9 to 1.7 ± 0.6 (mean difference −0.7, 95% CI −0.9 to −0.5, P < .001), mean HCS rose from 2.8 ± 0.7 to 3.1 ± 0.7 (mean difference 0.4, 95% CI 0.2 to 0.5, P < .001), and mean SUS score was 80.7 at 6 months.
  • In the safety cohort (N = 232), severe hypoglycemia incidence was 9.0 events per 100 person-years and DKA incidence was 0.6 events per 100 person-years; there were no CGM-related adverse reactions requiring treatment, and no serious adverse events were considered related to System use by the medical monitor.

Methods

  • Prospective, single-arm observational study (BURST; NCT05088265) enrolling participants with type 1 or type 2 diabetes prescribed Bigfoot Unity for multiple daily insulin injections between October 2021 and July 2023. The per protocol cohort included participants with baseline and 6-month HbA1c and at least 50% CGM data availability at 6 months (N = 102); the expanded cohort included those with baseline HbA1c and any HbA1c or glucose management indicator after day 68 (N = 171); the safety cohort included all who enrolled and completed training (N = 232).
  • Data included electronic questionnaires, at-home capillary HbA1c kits or electronic medical record HbA1c, CGM and System use data, patient-reported outcomes (T1-DDS, HCS, SUS), and safety events. Main analyses used longitudinal linear regression for HbA1c and PRO change, with robust regression and multiple imputation for skewed changes, adaptive Benjamini-Hochberg false discovery rate control, and P < .05 considered statistically significant.

Limitations

  • The paper states: single-arm design with no concurrent control group; relatively small per protocol sample; no baseline CGM metrics; primarily self-reported data; incomplete System data for some participants (45 of 216, 21%, who consented, started using the System, and were not screening failures had very limited data to analyze); and a small type 1 diabetes subgroup that limits interpretation.
  • Evident from the text: the pre-post observational design cannot establish causality, and the authors note that the larger improvement in those with baseline HbA1c ≥ 8% may reflect regression to the mean.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1210/clinem/dgae778

Cites

47 of 47 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

34 of 50 cited sources checked · 15 supported · 1 flagged · accuracy not yet measured

  • Interpretationcitation

    Occurrences of severe hypoglycemia and DKA (9.0 and 0.6 events per 100 person-years, respectively, in the safety cohort) observed during the study period are in line with other literature with estimates ranging from 7 to 130 and 4 to 8 events per 100 person-years, respectively, in insulin-requiring diabetes populations using MDI therapy.

    “Occurrences of severe hypoglycemia and DKA (9.0 and 0.6 events per 100 person-years, respectively, in the safety cohort) observed during the study period are in line with other literature with estimates ranging from 7 to 130 and 4 to 8 events per 100 person-years, respectively, in insulin-requiring diabetes populations using MDI therapy (39-43).”
    Quote in the paperNot a substantial claim3 of 5 sources checked
    • cites [39] UK Hypoglycaemia Study Group, 2007, Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration, Diabetologia source

      Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

      Experimental — accuracy not yet measured
    • cites [40] Karges, 2017, Association of insulin pump therapy vs insulin injection therapy with severe hypoglycemia, ketoacidosis, and glycemic control among children, adolescents, and young adults with type 1 diabetes, JAMA source
    • cites [41] Donnelly, 2005, Frequency and predictors of hypoglycaemia in type 1 and insulin-treated type 2 diabetes: a population-based study, Diabet Med source
    • cites [42] Khunti, 2016, Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin-treated type 1 and type 2 diabetes: the global HAT study, Diabetes Obes Metab source

      Split into 2 atoms — 0 confirmed, 1 partially supported, 1 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

      Checked by a reasoning model — may be wrong.

      Experimental — accuracy not yet measured
    • cites [43] Beck, 2012, The T1D exchange clinic registry, J Clin Endocrinol Metab source
  • Premisecitation

    Injection therapy is used by more than 80% of people with insulin-requiring diabetes.

    “As injection therapy is used by more than 80% of people with insulin-requiring diabetes, there is a clear need for intuitive, integrated systems to help multiple daily injection (MDI) patients interpret CGM data into actionable management steps to reduce the burden of demanding self-care directives and support telemedicine (3, 6, 10-13).”
    Quote in the paperSubstantial claim4 of 6 sources checked
    • cites [3] Peyrot, 2012, Insulin adherence behaviours and barriers in the multinational global attitudes of patients and physicians in insulin therapy study, Diabet Med source

      Table 1 (Participants and methods > Statistical analysis; page unavailable) reports that 98.5% of the 1,530 surveyed insulin users used a pen, syringe, or both, supporting the claim for this sample. The Study design section says participants were recruited from research-consumer panels; the paper does not establish that more than 80% of all people with insulin-requiring diabetes use injection therapy. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
    • cites [6] Tanenbaum, 2017, Optimal use of diabetes devices: clinician perspectives on barriers and adherence to device use, J Diabetes Sci Technol source

      The Results (Sample Characteristics; page unavailable) report clinicians’ estimates of insulin-pump use among their patients with type 1 diabetes, not the prevalence of injection therapy among all people with insulin-requiring diabetes. Searches for “more than 80%,” injection therapy, and related terms found no passage establishing the claimed figure. (LLM, conf=0.72)

      Experimental — accuracy not yet measured
    • cites [10] Polonsky, 2005, Assessing psychosocial distress in diabetes: development of the diabetes distress scale, Diabetes Care source

      The Results section reports that 50.4% of patients in three study samples used insulin, but does not say whether they used injections. Searches for injection therapy, insulin-requiring diabetes, and the claimed 80% figure found no passage addressing the claim. Page numbers were not available in our copy. (LLM, conf=0.76)

      Experimental — accuracy not yet measured
    • cites [11] Steenkamp, 2022, Adherence and persistence to insulin therapy in people with diabetes: impact of connected insulin pen delivery ecosystem, J Diabetes Sci Technol source
    • cites [12] Szmuilowicz, 2022, Stepwise approach to continuous glucose monitoring interpretation for internists and family physicians, Postgrad Med source
    • cites [13] Klonoff, 2018, Smart pens will improve insulin therapy, J Diabetes Sci Technol source

      The paper’s discussion of insulin delivery (page not provided) says pens are the most widely used devices worldwide. It reports pump uptake of 12%–40% among people with type 1 diabetes in specified regions and says uptake is exceedingly low among people with type 2 diabetes. This supports the general point that injection therapy is common, but the paper does not establish the claimed figure of more than 80% of all people with insulin-requiring diabetes. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
  • Premisecitation

    There is evidence that patients may not know how to interpret what to do with CGM data.

    “While recent guidelines call for continuous glucose monitoring (CGM) use for all who require insulin, regardless of diabetes type (7), there is also evidence that patients may not know how to interpret what to do with the CGM data (6, 8, 9).”
    Quote in the paperSubstantial claim2 of 3 sources checked
    • cites [6] Tanenbaum, 2017, Optimal use of diabetes devices: clinician perspectives on barriers and adherence to device use, J Diabetes Sci Technol source
    • cites [8] Goldman, 2022, Continuous glucose monitoring metrics: interpretation and integrations, Am J Manag Care source
    • cites [9] Lanning, 2020, Barriers to continuous glucose monitoring in people with type 1 diabetes: clinician perspectives, Diabetes Spectr source
  • Interpretationcitation

    The mean HbA1c, GMI, TIR, and TBR results (8.0%, 7.6%, 56%, and 1.0% at 6 months, respectively) demonstrate close adherence to established glycemic targets.

    “Considering the older age of participants and comorbid conditions reported, the mean HbA1c, GMI, TIR, and TBR results (8.0%, 7.6%, 56%, and 1.0% at 6 months, respectively) demonstrate close adherence to established glycemic targets (23, 24, 38).”
    Quote in the paperSubstantial claim3 of 3 sources checked
    • cites [23] American Diabetes Association Professional Practice Committee, 2021, 13. Older adults: standards of medical care in diabetes—2022, Diabetes Care source

      The Treatment Goals recommendations (section 13.3, page unavailable) set an individualized A1C goal of less than 8.0% for older adults with multiple coexisting conditions, so the reported mean of 8.0% is close to that target. The cited paper does not establish corresponding GMI, TIR, or TBR targets that would support describing all four results as close to established targets. The six-month results are the citing authors’ data, not results attributed to this source. (LLM, conf=0.85)

      Experimental — accuracy not yet measured
    • cites [24] American Diabetes Association Professional Practice Committee, 2021, 6. Glycemic targets: standards of medical care in diabetes—2022, Diabetes Care source

      The Recommendations (p. 5) establish glycemic targets, and a TBR of 1.0% is within the stated <4% target. But the cited paper gives a TIR target of >70% for many nonpregnant adults, well above the reported 56%, and describes an A1C goal of <8% as a possible less stringent goal for selected patients—not a general target met by an A1C of 8.0%. It does not set a numerical GMI target or report the citing study’s six-month results, so it does not support the assessment that all four results closely adhere to its targets. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
    • cites [38] Battelino, 2019, Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range, Diabetes Care source

      In the discussion of older and high-risk individuals (page not provided), the consensus sets a TIR target of >50% and a TBR target of <1%; the cited 56% TIR meets the first, while 1.0% TBR is close to but does not meet the second. The Relationship Between TIR and A1C section associates roughly 50% TIR with an A1C of approximately 8%, but the paper does not establish a GMI target that would substantiate the claim for all four measures. (LLM, conf=0.86)

      Experimental — accuracy not yet measured
  • Interpretationreasoning

    Comparing the average improvement in the current study with the MCID suggests that for the majority of participants, there may have been clinically meaningful improvement.

    “To place context around these results, note that the estimated minimally clinically important difference (MCID) for the 28-item T1-DDS total score is 0.19 in an insulin-requiring T1D population (19); comparing the average improvement in the current study with the MCID suggests that for the majority of participants, there may have been clinically meaningful improvement.”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [19] Fisher, 2016, Diabetes distress in adults with type 1 diabetes: prevalence, incidence and change over time, J Diabetes Complications source
    • Rests on an assumption: The MCID for the T1-DDS total score derived in an insulin-requiring T1D population applies to the current mixed T1D/T2D cohort.
  • Classified as probably not a substantial claim. 28
  • May combine two claims. 34
  • The quote only partly states this claim. 3

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

    Premisereasoning

    There is a clear need for intuitive, integrated systems to help MDI patients interpret CGM data into actionable management steps to reduce the burden of demanding self-care directives and support telemedicine.

    “As injection therapy is used by more than 80% of people with insulin-requiring diabetes, there is a clear need for intuitive, integrated systems to help multiple daily injection (MDI) patients interpret CGM data into actionable management steps to reduce the burden of demanding self-care directives and support telemedicine (3, 6, 10-13).”
    Quote in the paperNot a substantial claim4 of 6 sources checked
    • cites [3] Peyrot, 2012, Insulin adherence behaviours and barriers in the multinational global attitudes of patients and physicians in insulin therapy study, Diabet Med source

      The Discussion’s Clinical implications section says patients have difficulty adjusting insulin doses to daily changes and recommends reducing the burden of restrictive regimens. It does not support the specific need for integrated systems to interpret CGM data, support telemedicine, or the sentence’s more-than-80% figure. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
    • cites [6] Tanenbaum, 2017, Optimal use of diabetes devices: clinician perspectives on barriers and adherence to device use, J Diabetes Sci Technol source

      The Results report that clinicians saw patients’ difficulty understanding device information as a barrier, and the Conclusions describe complex adherence tasks and suggest remote monitoring and practical support. The paper does not specifically call for intuitive, integrated systems for MDI patients that turn CGM data into management steps or support telemedicine. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
    • cites [10] Polonsky, 2005, Assessing psychosocial distress in diabetes: development of the diabetes distress scale, Diabetes Care source

      The introduction (section labeled “L”; page unavailable) says that complex, demanding self-care directives can leave people with diabetes overwhelmed or discouraged. It does not address MDI patients, CGM interpretation, integrated systems, or telemedicine, so it supports only the self-care-burden rationale. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
    • cites [11] Steenkamp, 2022, Adherence and persistence to insulin therapy in people with diabetes: impact of connected insulin pen delivery ecosystem, J Diabetes Sci Technol source
    • cites [12] Szmuilowicz, 2022, Stepwise approach to continuous glucose monitoring interpretation for internists and family physicians, Postgrad Med source
    • cites [13] Klonoff, 2018, Smart pens will improve insulin therapy, J Diabetes Sci Technol source

      In “The Future for Smart Pens,” the paper envisions connected devices that integrate diabetes data and support insulin-dose decisions; its Conclusion says decision support could reduce the day-to-day burden of diabetes care. It does not specifically discuss helping MDI patients turn CGM data into actionable steps or supporting telemedicine. It also does not give the citing sentence’s more-than-80% figure for injection therapy. (LLM, conf=0.86)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S2 (checkable).

    Premisecitation

    For people with insulin-requiring diabetes, dosing instructions may be complex and confusing.

    “For people with insulin-requiring diabetes, dosing instructions may be complex and confusing (3-6).”
    Quote in the paperNot a substantial claim2 of 4 sources checked
    • cites [3] Peyrot, 2012, Insulin adherence behaviours and barriers in the multinational global attitudes of patients and physicians in insulin therapy study, Diabet Med source

      The Discussion reports dissatisfaction with regimen simplicity, and the Clinical implications section says patients have difficulty adjusting insulin doses to daily changes. These passages support the possibility that dosing is complex, but they do not say that dosing instructions themselves are confusing. No page numbers are available in our copy. (LLM, conf=0.82)

      Experimental — accuracy not yet measured
    • cites [4] Farsaei, 2014, Insulin adherence in patients with diabetes: risk factors for injection omission, Prim Care Diabetes source
    • cites [5] Page, 1981, Patient recall of self-care recommendations in diabetes, Diabetes Care source
    • cites [6] Tanenbaum, 2017, Optimal use of diabetes devices: clinician perspectives on barriers and adherence to device use, J Diabetes Sci Technol source

      The Abstract (page unavailable) describes insulin-pump use as requiring complex tasks, including carbohydrate counting and administering boluses. The Results (page unavailable) report clinicians’ perceptions that some patients do not understand pump information or features. These passages support complexity and possible confusion in device use, but do not specifically say that dosing instructions are confusing for people with insulin-requiring diabetes generally. (LLM, conf=0.83)

      Experimental — accuracy not yet measured

  • May combine two claims.

    Interpretationcitation

    Mean percent time of sensor use and mean coefficient of variation (84% and 31% at 6 months, respectively) are within established guidelines.

    “Other parameters such as the mean percent time of sensor use and mean coefficient of variation (84% and 31% at 6 months, respectively) are also within established guidelines (23, 24, 38).”
    Quote in the paperNot a substantial claim3 of 3 sources checked
    • cites [23] American Diabetes Association Professional Practice Committee, 2021, 13. Older adults: standards of medical care in diabetes—2022, Diabetes Care source

      The section on continuous glucose monitoring (13.3 Screening for early detection; page unavailable) reports a six-month trial and reduced glycemic variability, but gives no guideline threshold for sensor use or coefficient of variation. Searches for the 84% and 31% figures and for those metrics’ guidelines found no passage establishing that they are within guidelines. (LLM, conf=0.73)

      Experimental — accuracy not yet measured
    • cites [24] American Diabetes Association Professional Practice Committee, 2021, 6. Glycemic targets: standards of medical care in diabetes—2022, Diabetes Care source
    • cites [38] Battelino, 2019, Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range, Diabetes Care source

  • May combine two claims.

    Findingcitation

    Low and very low glucose events occurred at a low rate (mean of ∼1.3 and 0.2 events per person per week in the sixth month, respectively) and were in keeping with time below range meeting established standards.

    “Low and very low glucose events occurred at a low rate (mean of ∼1.3 and 0.2 events per person per week in the sixth month, respectively) and were in keeping with time below range meeting established standards (23, 24, 38).”
    Quote in the paperSubstantial claim3 of 3 sources checked
    • cites [23] American Diabetes Association Professional Practice Committee, 2021, 13. Older adults: standards of medical care in diabetes—2022, Diabetes Care source

      The Hypoglycemia section gives a threshold for low glucose, and section 13.3 reports time spent below 70 mg/dL in a separate six-month CGM trial. Neither passage gives the claimed sixth-month event rates or a time-below-range standard against which to assess them. I searched for those rates and for time-below-range targets in our copy. (LLM, conf=0.72)

      Experimental — accuracy not yet measured
    • cites [24] American Diabetes Association Professional Practice Committee, 2021, 6. Glycemic targets: standards of medical care in diabetes—2022, Diabetes Care source
    • cites [38] Battelino, 2019, Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range, Diabetes Care source

  • May combine two claims.

    Interpretationcitation

    The prospective 6-month study reported here showed similar results to 3-month data presented previously and similar glycemic control to a retrospective cohort using Bigfoot Unity.

    “In general, the prospective 6-month study reported here showed similar results to 3-month data presented previously (35) and similar glycemic control to a retrospective cohort using Bigfoot Unity (34); here, the baseline HbA1c was higher (9.1% vs 8.4%), which may reflect health status or other demographic biases in those who consent to participate in an ongoing study vs those who do not (36).”
    Quote in the paperNot a substantial claim2 of 3 sources checked
    • cites [35] Malone, 2023, 936-P: three-month interim analysis from the prospective bigfoot unity real world study (BURST), Diabetes source
    • cites [34] Baliga, 2023, First real-world experience with bigfoot unity: a 6-month retrospective analysis, Clin Diabetes source
    • cites [36] Kho, 2009, Written informed consent and selection bias in observational studies using medical records: systematic review, BMJ source

  • May combine two claims.

    Study design and conductcitation

    45 of 216 (21%) who consented, started using the System and were not screening failures, had very limited data to analyze; this percentage with incomplete data could introduce bias and would be considered relatively high in a controlled trial but is anticipated in the real-world setting in an older population with comorbid conditions.

    “For example, 45 of 216 (21%) who consented, started using the System and were not screening failures, had very limited data to analyze; this percentage with incomplete data could introduce bias and would be considered relatively high in a controlled trial but is anticipated in the real-world setting in an older population with comorbid conditions (49).”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [49] Jacobsen, 2021, Predictors of attrition in a longitudinal population-based study of aging, Int Psychogeriatr source

      Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

      Experimental — accuracy not yet measured

  • May combine two claims.

    Findingown data

    In the per protocol cohort, TIR (70-180 mg/dL) was 55 ± 25% in the first 2 weeks, 56 ± 24% in the third month, and 56 ± 23% in the sixth month.

    “TIR (70-180 mg/dL) in the first 2 weeks, third month, and sixth month of use was 55% ± 25%, 56% ± 24%, and 56% ± 23%, respectively.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    In the per protocol cohort, median sensor use was 87% (IQR 74-93) in the first 2 weeks, 86% (IQR 77-92) in the third month, and 84% (IQR 72-91) in the sixth month.

    “Median sensor use was 87% with an interquartile range (IQR) of 74% to 93% in the first 2 weeks; median sensor use was 86% (IQR, 77% to 92%) and 84% (IQR, 72% to 91%) in the per protocol cohort in the third month and sixth month of use, respectively.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In the per protocol cohort, participants with baseline HbA1c ≥8% (N=76) had greater improvement (mean baseline 9.7 ± 1.4% to 8.3 ± 1.2% at 6 months), while those with lower baseline HbA1c had small changes in glycemic control.

    “Those with higher baseline HbA1c (≥ 8%; N = 76), had greater improvement (mean baseline HbA1c of 9.7% ± 1.4% improved to 8.3% ± 1.2% at 6 months) while those with lower baseline HbA1c had small changes in glycemic control (Table 2 and Fig. 2C).”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: At-home capillary blood HbA1c values and electronic medical record HbA1c values are comparable for the analysis.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    In the per protocol cohort, 42% had used CGM previously.

    “Of 102 participants in the per protocol cohort, median age was 59 years, 87% had T2D, 42% used CGM previously, 62% were White non-Hispanic, and 59% female.”
    • Also stated in: § Participant Characteristics · plain
      “CGM had been previously used by 42% (see Table 1).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The safety cohort reflects 232 of 250 (93%) of those who enrolled.

    “The safety cohort reflects 232 of 250 (93%) of those who enrolled.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In the per protocol cohort, time below range <70 mg/dL was 0.6 ± 1.2% in the first 2 weeks, 0.8 ± 1.2% in the third month, and 1.0 ± 1.4% in the sixth month.

    “Time below range (TBR; < 70 mg/dL) was 0.6% ± 1.2%, 0.8% ± 1.2%, and 1.0% ± 1.4% and time < 54 mg/dL was 0.01% ± 0.10%, 0.03% ± 0.08%, and 0.04% ± 0.14% in the first 2 weeks, the third month, and the sixth month periods, respectively (Table 3).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    In the per protocol cohort, 69% had diabetes for 10 years or more.

    “Sixty-two percent (62%) selected White non-Hispanic as their race/ethnic background (see Table 1 for categories), 59% were female, and 69% had diabetes for 10 years or more.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    In the per protocol cohort, 62% were White non-Hispanic.

    “Of 102 participants in the per protocol cohort, median age was 59 years, 87% had T2D, 42% used CGM previously, 62% were White non-Hispanic, and 59% female.”
    • Also stated in: § Participant Characteristics · plain
      “Sixty-two percent (62%) selected White non-Hispanic as their race/ethnic background (see Table 1 for categories), 59% were female, and 69% had diabetes for 10 years or more.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    In the per protocol cohort, 59% were female.

    “Of 102 participants in the per protocol cohort, median age was 59 years, 87% had T2D, 42% used CGM previously, 62% were White non-Hispanic, and 59% female.”
    • Also stated in: § Participant Characteristics · plain
      “Sixty-two percent (62%) selected White non-Hispanic as their race/ethnic background (see Table 1 for categories), 59% were female, and 69% had diabetes for 10 years or more.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In the per protocol cohort, there was no statistically significant interaction in HbA1c improvement from baseline in other subgroups tested, including those with and without prior CGM experience, with the exception of those living in rural vs urban areas, who had higher baseline HbA1c.

    “There was no statistically significant interaction in HbA1c improvement from baseline in other subgroups tested, including those with and without prior CGM experience, with the exception of those living in rural (vs urban) areas, who had higher baseline HbA1c (Table 2).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    In the per protocol cohort, 87% had type 2 diabetes.

    “Of 102 participants in the per protocol cohort, median age was 59 years, 87% had T2D, 42% used CGM previously, 62% were White non-Hispanic, and 59% female.”
    • Also stated in: § Participant Characteristics · plain
      “Within the per protocol cohort (N = 102), median age was 59 years (range, 22-82) and 89 of 102 (87%) had T2D.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    In the per protocol cohort, median age was 59 years (range 22-82).

    “Of 102 participants in the per protocol cohort, median age was 59 years, 87% had T2D, 42% used CGM previously, 62% were White non-Hispanic, and 59% female.”
    • Also stated in: § Participant Characteristics · plain
      “Within the per protocol cohort (N = 102), median age was 59 years (range, 22-82) and 89 of 102 (87%) had T2D.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In the per protocol cohort, six severe hypoglycemia events occurred in 4 participants, and none were System-related.

    “Six severe hypoglycemia events occurred in 4 participants (none System-related) and no diabetic ketoacidosis events occurred in the per protocol cohort.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The expanded cohort reflects 171 of 207 (83%) who were eligible for outcomes analysis.

    “The expanded cohort reflects 171 of 207 (83%) who were eligible for outcomes analysis and the per protocol cohort represents 102 of 153 (67%) eligible for the 6-month per protocol analysis (Fig. 1).”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the per protocol cohort, median rapid-acting insulin doses per day were 2.9, 2.6, and 2.4 in the first 2 weeks, third month, and sixth month, respectively.

    “The median number of rapid-acting insulin doses per day was 2.9 (IQR 2.2, 3.4), 2.6 (IQR 1.9, 3.1) and 2.4 (IQR 1.9, 3.0) in the first 2 weeks, third month, and sixth month of use, respectively (Table 3).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    Over 6 months, total System use represented 89.9 person-years in the per protocol cohort and 135.6 person-years in the expanded cohort.

    “Within the per protocol and the expanded cohorts, over the course of 6 months, total System use represented 89.9 and 135.6 person-years, respectively.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based). The quote only partly states this claim.

    Findingown data

    In the per protocol cohort, median long-acting insulin doses per week were 7.0, 7.0, and 6.9 in the first 2 weeks, third month, and sixth month, respectively.

    “The average number of long-acting doses per week was 7.0 (IQR 6.5, 7.5), 7.0 (IQR 6.5, 7.3) and 6.9 (IQR 6.3, 7.0) in the first 2 weeks, third month, and sixth month of use, respectively.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In the per protocol cohort, mean T1-DDS score was 2.4 ± 0.9 at baseline and 1.7 ± 0.6 at 6 months, with a mean difference of −0.7 (95% CI −0.9 to −0.5, P < .001).

    “Mean T1-DDS score at baseline was 2.4 ± 0.9 and fell to 1.7 ± 0.6 at 6 months with a mean difference of −0.7 (95% CI −0.9 to −0.5, P < .001).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The per protocol cohort represents 102 of 153 (67%) eligible for the 6-month per protocol analysis.

    “The expanded cohort reflects 171 of 207 (83%) who were eligible for outcomes analysis and the per protocol cohort represents 102 of 153 (67%) eligible for the 6-month per protocol analysis (Fig. 1).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Only a small number of participants with low distress or moderate-to-high hypoglycemic confidence at baseline worsened after 6 months (5% and 18%, respectively).

    “It should be noted that there were only a small number of participants who at baseline had relatively low distress (mean T1-DDS < 2.0) or moderate to high hypoglycemic confidence (mean HCS > 3.0) and worsened (ie, crossing their respective cutpoints) after 6 months (5% and 18% of participants, respectively).”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the per protocol cohort, mean CGM-measured hypoglycemia events per week (<70 mg/dL) were 1.0, 1.1, and 1.3 in the first 2 weeks, third month, and sixth month, respectively.

    “The average number of CGM-measured hypoglycemia events per week (< 70 mg/dL or < 3.9 mmol/L) was 1.0 ± 1.9, 1.1 ± 1.6, and 1.3 ± 1.6 in the first 2 weeks, third month, and sixth month of use, respectively (Table 3).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In the HbA1c < 8% subgroup at 6 months, there was little change in glycemic control, some improvement in T1-DDS (decreased ∼0.5 points), similar improvement of HCS (increased 0.4 points), and a similar TBR (∼1.0%) compared to the overall cohort.

    “However, we evaluated the HbA1c < 8% subgroup at 6 months and although there was little change in glycemic control, some improvement in T1-DDS (decreased ∼0.5 points), similar improvement of HCS (increased 0.4 points), and a similar TBR (∼1.0%) compared to the overall cohort was observed, suggesting psychosocial benefits with limited hypoglycemia.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    In the safety cohort of N = 232, 15 severe hypoglycemia events occurred in 11 participants; all but 1 were in participants with T2D.

    “In the safety cohort of N = 232, 15 severe hypoglycemia events occurred in 11 participants; all but 1 were in participants with T2D.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Here, 42% of participants were current CGM users at enrollment and had similar HbA1c improvements (1.1% vs 1.2%) when switching to Bigfoot Unity compared to non-CGM users at enrollment.

    “Here, 42% of participants were current CGM users at enrollment and had similar HbA1c improvements (1.1% vs 1.2%) when switching to Bigfoot Unity compared to non-CGM users at enrollment.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In the safety cohort, 2 other serious hyperglycemic events needing treatment in a healthcare facility occurred in 2 participants, 1 with T1D and 1 with T2D; neither was using the System at the time.

    “Additionally, in the safety cohort, 1 DKA event occurred in a person with T2D and 2 other serious hyperglycemic events needing treatment in a healthcare facility occurred in 2 participants, 1 with T1D and 1 with T2D; neither was using the System at the time these events occurred.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingnone given

    In this prospective study of Bigfoot Unity users, most participants had T2D and about 40% had used CGM previously.

    “In this prospective study of Bigfoot Unity users, most participants had T2D and about 40% had used CGM previously.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Observations of improved glycemic control were coupled with statistically significant improvements in diabetes distress (mean change −0.7 points) and improvements in hypoglycemia confidence (mean change 0.4 points).

    “Observations of improved glycemic control were coupled with statistically significant improvements in diabetes distress (mean change −0.7 points) and improvements in hypoglycemia confidence (mean change 0.4 points).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The T1D subgroup was small, but there appears to be a difference in HbA1c improvement (0.7% vs 1.2%), TIR (39% vs 58%), TBR (1.6% vs 0.9%), and time above range (59% vs 40%) between T1D and T2D subgroups, respectively.

    “The T1D subgroup was small (see Figs. 1 and 3), but there appears to be a difference in HbA1c improvement (0.7% vs 1.2%), TIR (39% vs 58%), TBR (1.6% vs 0.9%), and time above range (59% vs 40%) between T1D and T2D subgroups, respectively.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    With regard to diabetes distress, those with T1D had higher baseline distress than those with T2D (2.7 vs 2.3) with both groups having similar improvement (∼0.7 points).

    “With regard to diabetes distress, those with T1D had higher baseline distress than those with T2D (2.7 vs 2.3) with both groups having similar improvement (∼0.7 points); those with T1D had similar baseline hypoglycemia confidence as those with T2D (2.9 vs 2.8) but those with T1D did not show improvement at 6 months (−0.01 points) while those with T2D improved ∼0.5 points.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Those with T1D had similar baseline hypoglycemia confidence as those with T2D (2.9 vs 2.8) but those with T1D did not show improvement at 6 months (−0.01 points) while those with T2D improved ∼0.5 points.

    “With regard to diabetes distress, those with T1D had higher baseline distress than those with T2D (2.7 vs 2.3) with both groups having similar improvement (∼0.7 points); those with T1D had similar baseline hypoglycemia confidence as those with T2D (2.9 vs 2.8) but those with T1D did not show improvement at 6 months (−0.01 points) while those with T2D improved ∼0.5 points.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    The frequency of hypoglycemia observed at 6 months was substantially below established targets of <4% for time below 70 mg/dL and <1% for time below 54 mg/dL.

    “In this study primarily of older adults with T2D using MDI, durable glycemic improvement occurred using the System at 6 months, with the frequency of hypoglycemia being substantially below established targets of < 4% and < 1% for time below 70 and 54 mg/dL, respectively.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    The false discovery rate was controlled by using the adaptive Benjamini-Hochberg procedure.

    “The false discovery rate was controlled by using the adaptive Benjamini-Hochberg procedure.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Prespecified outcomes for analysis were GMI, percent time in range, percent time below range, percent time above range, sensor data availability, mean sensor glucose and coefficient of variation, mean sensor scans, and dose events.

    “Prespecified outcomes for analysis were GMI (an estimate of HbA1c from CGM-measured mean glucose) calculated as described (17), percent time in range (TIR; 70-180 mg/dL, 3.9-10.0 mmol/L), percent time below range (< 70 mg/dL and < 54 mg/dL or < 3.9 mmol/L and < 3.0 mmol/L, respectively), percent time above range (> 180 mg/dL and > 250 mg/dL or > 10.0 mmol/L and > 13.9 mmol/L, respectively), sensor”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    The sample size was not based on statistical power.

    “As this was an observational analysis, the sample size was not based on statistical power.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    For reported events during the study, JCHR staff would attempt to contact participants to confirm reported events indeed met the study definitions.

    “For reported events during the study, JCHR staff would attempt to contact participants to confirm reported events indeed met these definitions (it was not possible to confirm baseline information in a similar way).”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductreasoning

    The T1-DDS, though initially developed for T1D, was deemed the better choice for assessing diabetes distress in the current study because the sample included a mix of adults with T1D and T2D, and all were insulin users.

    “Of note, the T1-DDS, though it was initially developed for T1D, was deemed the better choice for assessing diabetes distress in the current study, since the sample included a mix of adults with T1D and T2D, and all were insulin users.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Recent guidelines call for continuous glucose monitoring (CGM) use for all who require insulin, regardless of diabetes type.

    “While recent guidelines call for continuous glucose monitoring (CGM) use for all who require insulin, regardless of diabetes type (7), there is also evidence that patients may not know how to interpret what to do with the CGM data (6, 8, 9).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [7] Samson, 2023, American Association of Clinical Endocrinology consensus statement: comprehensive type 2 diabetes management algorithm—2023 update, Endocr Pract source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The analysis was prespecified to be completed when approximately 100 participants had sufficient data to be included in the per protocol analysis.

    “The analysis was prespecified to be completed when approximately 100 participants had sufficient data to be included in the per protocol analysis.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The prespecified protocol, consent forms, data collection forms, and recruitment materials were approved by the JCHR institutional review board.

    “The prespecified protocol, consent forms, data collection forms, and recruitment materials were approved by the JCHR institutional review board.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given

    CGM metrics were calculated over a 28-day period with the most data and required at least 50% CGM data available (at least 336 hours) in the 6-month period to be included in the per protocol analyses.

    “CGM metrics were calculated over a 28-day period with the most data and required at least 50% CGM data available (at least 336 hours) in the 6-month period to be included in the per protocol analyses.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Prespecified subgroup analyses included baseline HbA1c ≥8% vs <8%, age ≥65 vs <65 years, ethnicity, economic status, education, living areas, and previous CGM experience.

    “Prespecified subgroup analyses included those with baseline HbA1c ≥ 8% vs < 8% (≥ 64 mmol/mol vs < 64 mmol/mol), those ≥ 65 years vs < 65 years, ethnicity, economic status, education, living areas, and those with and without previous CGM experience.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    Given baseline data indicating that the vast majority took 2 (37%) or 3 (43%) meals per day, findings of a median of 2.6 and 2.4 rapid-acting doses per day in the third and sixth month (slightly down from 2.9 in the first 2 weeks of use) suggest minimal missed meal injections.

    “Given baseline data indicating that the vast majority took 2 (37%) or 3 (43%) meals per day, our findings of a median of 2.6 and 2.4 rapid-acting doses per day in the third and sixth month (slightly down from 2.9 in the first 2 weeks of use) suggest minimal missed meal injections.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    Percent time < 54 mg/dL was on average 0.04% at 6 months and while this was statistically higher compared to the first 2 weeks of use (0.01%), it is likely not clinically meaningful.

    “It can be noted that percent time < 54 mg/dL was on average 0.04% at 6 months and while this was statistically higher compared to the first 2 weeks of use (0.01%), it is likely not clinically meaningful.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    Based on the GMI estimate of HbA1c within the first 2 weeks of being on the System, and comparison with baseline HbA1c, there was rapid glycemic improvement which remained stable through month 6.

    “Based on the GMI estimate of HbA1c within the first 2 weeks of being on the System, and comparison with the baseline HbA1c, there was rapid glycemic improvement which remained stable through month 6.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premiseown data

    A PubMed search using the terms connected insulin pen or smart insulin pen on February 27, 2024, returned 55 articles, of which only 11 had relevant effectiveness or safety-related data for connected insulin pen systems.

    “A PubMed search using the terms connected insulin pen or smart insulin pen on February 27, 2024, returned 55 articles, of which only 11 had relevant effectiveness or safety-related data for connected insulin pen systems (most were reviews of or perspectives on smart pen technology); surprisingly, none addressed the prospective collection of clinically relevant adverse events such as severe hypogly”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    For context for the SUS score, scores > 80 are considered excellent system use.

    “For context for the SUS score, scores > 80 are considered excellent system use (48) and thus, the 6-month mean of 80.7 indicates that the System supports an above average user experience.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [48] Lewis, 2018, Item benchmarks for the system usability scale, J User Exp source

  • May combine two claims.

    Study design and conductreasoning

    Because the recall process for reporting severe hypoglycemia and DKA events differed between baseline and the study period and only the latter had a confirmation process by the medical monitor, it is not appropriate to compare self-reported events at baseline to those occurring during the study.

    “It should be noted that because the recall process for reporting severe hypoglycemia and DKA events differed between baseline and the study period and, because only the latter had a confirmation process by the medical monitor that was not possible at baseline, we do not think it is appropriate to compare self-reported events at baseline to those occurring during the study.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    The authors found similar glycemic outcomes regardless of race, age, diabetes duration, presence of baseline diabetes complications, income, education, and prior sensor experience, which speaks to the generalizability of System use.

    “We found similar glycemic outcomes regardless of race, age, diabetes duration, presence of baseline diabetes complications, income, education, and prior sensor experience, which speaks to the generalizability of System use.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The study design did not include baseline CGM metrics (only baseline HbA1c and PRO data were available).

    “The study design also did not include baseline CGM metrics (only baseline HbA1c and PRO data were available).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    An additional limitation was that the number of participants with T1D was small, which limits interpretation.

    “Finally, an additional limitation was that the number of participants with T1D was small, which limits interpretation.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Strengths of the study include the prospective collection of HbA1c, PRO, CGM and clinically relevant adverse events in a real-world and diverse population using this relatively new connected pen cap system.

    “With these limits in mind, the strengths of the study include the prospective collection of HbA1c, PRO, CGM and clinically relevant adverse events in a real-world and diverse population using this relatively new connected pen cap system.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductown data

    To mitigate potential dropout bias in the per protocol analysis and maximize analyzable data without requiring stringent System use, the authors conducted an expanded cohort analysis which demonstrated similar demographics, glycemic and PRO improvement, System use, and safety outcomes.

    “Nonetheless, to mitigate potential dropout bias in the per protocol analysis and maximize analyzable data without requiring stringent System use, we conducted our expanded cohort analysis which demonstrated similar demographics, glycemic and PRO improvement, System use, and safety outcomes.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductnone given

    Limitations of this study include the single-arm study design with no concurrent control group and relatively small sample size in the per protocol cohort.

    “Limitations of this study include the single-arm study design with no concurrent control group and relatively small sample size in the per protocol cohort.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductnone given

    The study data collected were primarily direct from participant (ie, self-reported) which likely limited collection of complete data.

    “Additionally, the study data collected were primarily direct from participant (ie, self-reported) which likely limited collection of complete data.”
    Quote in the paperNot a substantial claim
60 of 60

  • The paper relies on this without support.

    The observed glycemic improvement is attributable to use of the Bigfoot Unity System rather than to other factors.

    “In this study primarily of older adults with T2D using MDI, durable glycemic improvement occurred using the System at 6 months, with the frequency of hypoglycemia being substantially below established targets of < 4% and < 1% for time below 70 and 54 mg/dL, respectively.”

  • The paper relies on this without support.

    At-home capillary blood HbA1c values and electronic medical record HbA1c values are comparable for the analysis.

    “If a participant did not collect the blood sample within the acceptable window (−90 to 0 days for baseline) or the blood sample was received at the central lab beyond the stability period, an electronic medical record HbA1c value was used.”

  • The paper relies on this without support.

    The observed improvements in glycemic control and psychosocial outcomes are attributable to use of the Bigfoot Unity System rather than other factors.

    “For this cohort, consisting primarily of older adults with T2D and having suboptimal glycemic control, using the System resulted in rapid and durable improvement in glycemic control.”
    “Limitations of this study include the single-arm study design with no concurrent control group and relatively small sample size in the per protocol cohort.”

  • The paper relies on this without support.

    The Bigfoot Unity System is intended for once-daily long-acting insulin dosing.

    “Given that the System is intended for once-daily long-acting insulin dosing, the median of 7.0 and 6.9 long-acting doses per week in month 3 and 6 is encouraging.”

  • The paper relies on this without support.

    The MCID for the T1-DDS total score derived in an insulin-requiring T1D population applies to the current mixed T1D/T2D cohort.

    “To place context around these results, note that the estimated minimally clinically important difference (MCID) for the 28-item T1-DDS total score is 0.19 in an insulin-requiring T1D population (19); comparing the average improvement in the current study with the MCID suggests that for the majority of participants, there may have been clinically meaningful improvement.”
5 of 5

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Per-protocol hospitalization breakdown exceeds its total

    Minor

    Table 5 reports 13 hospitalizations for reasons other than severe hypoglycemia and DKA in the per-protocol cohort, but its using-system/not-using-system breakdown totals 22.

    Reported 13 · recomputed 22

  • Median sensor availability is described as a mean

    Minor

    The discussion calls the sixth-month sensor-use value of 84% a mean, whereas Table 3 identifies 84% as the median.

2 of 2

Cites

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Cited by

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Related

Authors
Tillman, J. B., Beck, R. W., Polonsky, W. H., Calhoun, P., Mouse, T., Bailey, R., Jacoby, J., Nandan, R., Sheikh, F. N., & Malone, J. K.
Affiliations
  • Abbott Diabetes Care (United States)
  • Jaeb Center for Health Research (US)
  • Behavioral Diabetes Institute , San Diego, CA 92121 ,
  • Department of Fluorescence Imaging, Intuitive , Sunnyvale, CA 94086 ,
Corresponding author
Tillman, John B
ORCID
Venue
The Journal of Clinical Endocrinology & Metabolism
Publisher
The Endocrine Society
Published
2024-11-15
Volume
110
Issue
8
Pages
2134-2146
ISSN
  • 0021-972X (ISSN-L)
  • 1945-7197
DOI
10.1210/clinem/dgae778
PMC
PMC12261103
OpenAlex
W4404400746
Semantic Scholar
8fa27c74d834540c067ed02b06091edd786c8f4b
Cited by
1
References
47
Citations by year
2025: 1
FWCI
0.29
Type
journal article
Language
en
Open access
Licence
Locations
  • The Journal of Clinical Endocrinology & Metabolism (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • PubMed Central (submittedVersion, cc-by-nc-nd)
Funders
Abbott
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Keywords
continuous glucose monitoring, mobile application, multiple daily insulin injections, type 2 diabetes, type 1 diabetes, glycemic control, HbA1c, time in range, hypoglycemia, severe hypoglycemia, diabetic ketoacidosis, real-world evidence, older adults
MeSH terms
Glycemic Control, Adult, Aged, Blood Glucose, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Male, Middle Aged, Prospective Studies, Blood Glucose Self-Monitoring

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-09.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-09.

Cited sources are checked by gpt-6-sol.

Statistics and arithmetic are recomputed, not judged.

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