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Cited by 40Diabetes Management and ResearchDiabetes Management and EducationMobile Health and mHealth Applications

Efficacy of a Smart Insulin Pen Cap for the Management of Patients with Uncontrolled Type 2 Diabetes: A Randomized Cross-Over Trial

Open access
Galindo, Rodolfo J., Ramos, Clementina, Cardona, Saumeth, Vellanki, Priyathama, Davis, Georgia M., Oladejo, Omolade, Albury, Bonnie, Dhruv, Neil +2 more·2023·Journal of Diabetes Science and Technology
DOI 10.1177/19322968211033837PMC PMC9846390
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Abstract

Background: We studied a smart insulin pen cap that can be plugged to several brand of insulin pens, to track insulin administration via smart-phone Bluetooth technology, with alarm/reminder system aiming. Methods: This pilot randomized, cross-over design study assessed the use of a smart insulin pen cap in improving adherence, glycemic control and patient satisfaction in insulin-treated patients with poorly controlled type 2 diabetes. Eighty patients on basal insulin ± oral agents with hemoglobin A1C (HbA1c) between 7.0% and 12.0% were randomized to a 12-week active phase receiving alarms/reminders and a 12-week control/masked phase without feedback. We assessed differences between groups on treatment adherence, insulin omission, and mistiming of insulin injections, HbA1c, treatment satisfaction (using Diabetes Treatment Satisfaction Questionnaire Status). Results: Compared to the control/masked phase, the active phase resulted in lower mean daily blood glucose (147.0 ± 34 vs 157.6 ± 42 mg/dL, P < .01); and greater reduction in HbA1c from baseline (−0.98% vs −0.72%, P = .006); however, no significant differences in treatment adherence, insulin omission or insulin mistiming were observed. High patient satisfaction scores were reported in both active and control phases, with DTSQc of 15.5 ± 3.7 and 14.9 ± 3.6, respectively. Statistical models showed no residual effect after cross-over between active and control phases. Conclusions: The results of this pilot study indicates that this smart insulin pen cap was effective in improving glycemic control with overall good satisfaction in insulin treated patients with type 2 diabetes. Future studies are needed to confirm its potential for improving care in insulin treated patients with diabetes.

AI snapshot

Written from the paper’s full text.

TL;DR

In a pilot randomized cross-over trial of insulin-treated adults with poorly controlled type 2 diabetes, a smart insulin pen cap with alarms/reminders improved glycemic control modestly versus a masked control phase. Treatment adherence, insulin omission, and mistiming did not differ significantly, while satisfaction was high in both phases.

Key findings

  • Active phase vs control/masked phase: lower mean daily blood glucose (147.0 ± 34 vs 157.6 ± 42 mg/dL, P < .01) and greater HbA1c reduction from baseline (−0.98% vs −0.72%, P = .006).
  • No significant differences in treatment adherence, insulin omission, or insulin mistiming were observed between phases.
  • Patient satisfaction was high in both phases: DTSQc 15.5 ± 3.7 active vs 14.9 ± 3.6 control.
  • Statistical models showed no residual effect after cross-over between active and control phases.

Methods

  • Pilot, prospective, randomized 1:1, 26-week cross-over trial in adults aged 18–80 with type 2 diabetes, HbA1c 7.0% to ≤12%, on basal insulin ≤0.5 U/kg/day ± oral agents, self-injecting insulin >3 months.
  • After a 2-week run-in, 88 consented participants had 8 screen failures; 80 were randomized to a 12-week active phase with alarms/reminders or a 12-week control/masked phase without feedback, then crossed over.
  • Outcomes included adherence, insulin omission/mistiming, HbA1c, mean daily/fasting glucose, and DTSQc satisfaction; continuous outcomes used the Grizzle model, binary outcomes Prescott’s test, and paired t-tests for baseline change, with P < .05.

Limitations

  • Stated: long-term prior insulin use may explain lack of adherence difference; free smartphones, insulin, and supplies plus frequent calls/visits may have raised adherence and satisfaction in both groups; the HbA1c difference was statistically significant but of small clinical relevance; larger real-world studies are needed.
  • Evident from text: participants and investigators were not masked to treatment allocation, the study was a pilot with short 12-week phases, and the sample was predominantly Black and low-income from two Atlanta sites.

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

Integrity signals

Registry

Crossref · 10.1177/19322968211033837

Cites

27 of 27 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

6 of 11 cited sources checked · 3 supported · 0 flagged · accuracy not yet measured

  • Findingown data
    § Results

    In patients starting the active phase and crossing to the control phase, there was a reduction in the proportion of patients with missed dosing (22% vs 24%, P = .04).

    “There was a reduction in the proportion of patients with missed dosing (22% vs 24%, P = .04), for patients starting the active phase and crossing to the control phase.”
    Quote in the paperNot a substantial claim
  • Findingown data
    § Abstract

    In insulin-treated patients with poorly controlled type 2 diabetes, the active phase resulted in a greater reduction in HbA1c from baseline compared to the control phase (−0.98% vs −0.72%, P = .006).

    “and greater reduction in HbA1c from baseline (−0.98% vs −0.72%, P = .006);”
    • Also stated in: § Results · plain
      “Overall, there was a small but significant difference in HbA1c reduction from baseline in the active vs. control phase (−0.98% ± 2.0% vs −0.70% ± 1.7%, P = .006).”
    Quote in the paperSubstantial claim
  • Findingown data
    § Results

    In insulin-treated patients with poorly controlled type 2 diabetes, there were no differences between the active and control phases in the rates of severe hyperglycemia >300 mg/dl or hypoglycemia <70 mg/dl.

    “There were no differences on the rates of severe hyperglycemia >300 mg/dl or hypoglycemia <70 mg/dl between groups.”
    Quote in the paperSubstantial claim
  • Findingown data
    § Abstract

    In insulin-treated patients with poorly controlled type 2 diabetes, the active phase with alarms/reminders resulted in lower mean daily blood glucose compared to the control/masked phase (147.0 ± 34 vs 157.6 ± 42 mg/dL, P < .01).

    “Compared to the control/masked phase, the active phase resulted in lower mean daily blood glucose (147.0 ± 34 vs 157.6 ± 42 mg/dL, P < .01);”
    Quote in the paperSubstantial claim
  • Interpretationown data
    § Discussion

    In this pilot cross-over randomized controlled trial, the smart insulin pen cap was safe in insulin-treated patients with type 2 diabetes.

    “In conclusion, this pilot cross-over randomized controlled trial using a mobile health technology showed that this smart insulin pen cap was safe, with a tendency towards improvement in glycemic control parameters, and with overall high satisfaction rates.”
    Quote in the paperSubstantial claim
  • May combine two claims. 9
  • Classified as probably not a substantial claim. 10
  • The quote only partly states this claim. 4

  • May combine two claims.

    Premisecitation
    § Introduction

    Poor adherence to insulin administration is common in patients with diabetes, with up to half reporting poor adherence and one-third reporting insulin omission.

    “Among factors that could explain the low rate of optimal response to insulin therapy, poor adherence to insulin administration has been reported in up to half of patients with diabetes,7-9 with one-third of patients reporting an average of 3 episodes of insulin omission within the previous month.8,10”
    Quote in the paperSubstantial claim2 of 4 sources checked
    • cites [7] 7. Stolpe S, Kroes MA, Webb N, Wisniewski T. A systematic review of insulin adherence measures in patients with diabetes. J Manag Care Spec Pharm. 2016;22(11):1224-1246. [DOI] [PMC free article] [PubMed] [Google Scholar] source

      The introduction (section D; page not supplied) says poor adherence to insulin regimens is common in people with diabetes. It does not give the claimed figures of up to half reporting poor adherence or one-third reporting an average of three omissions in the previous month. (LLM, conf=0.86)

      Experimental — accuracy not yet measured
    • cites [8] 8. Brod M, Rana A, Barnett AH. Adherence patterns in patients with type 2 diabetes on basal insulin analogues: missed, mistimed and reduced doses. Curr Med Res Opin. 2012;28(12):1933-1946. [DOI] [PubMed] [Google Scholar] source
    • cites [9] 9. Tiv M, Viel JF, Mauny F, et al. Medication adherence in type 2 diabetes: the ENTRED study 2007, a French population-based study. PLoS One. 2012;7(3):e32412. [DOI] [PMC free article] [PubMed] [Google Scholar] source

      The Results (Medication adherence; page unavailable) report that 39% of patients had good medication adherence, supporting the general point that suboptimal adherence is common. The paper does not give an insulin-administration-specific estimate of up to half. The insulin-omission figure is attached to other citations in the citing sentence, not to this paper. (LLM, conf=0.85)

      Experimental — accuracy not yet measured
    • cites [10] 10. Peyrot M, Rubin RR, Polonsky WH, Best JH. Patient reported outcomes in adults with type 2 diabetes on basal insulin randomized to addition of mealtime pramlintide or rapid-acting insulin analogs. Curr Med Res Opin. 2010;26(5):1047-1054. [DOI] [PubMed] [Google Scholar] source

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

    Premisecitation
    § Discussion

    A large proportion of patients with type 2 diabetes receiving basal insulin do not achieve target HbA1c <7.0%.

    “Despite significant expansion on our insulin portfolio during the past decade, a large proportion of patients with type 2 diabetes receiving basal insulin do not achieve target HbA1c <7.0%.4,6,25”
    Quote in the paperNot a substantial claim2 of 3 sources checked
    • cites [4] 4. Esposito K, Chiodini P, Bellastella G, Maiorino MI, Giugliano D. Proportion of patients at HbA1c target <7% with eight classes of antidiabetic drugs in type 2 diabetes: systematic review of 218 randomized controlled trials with 78 945 patients. Diabetes Obes Metab. 2012;14(3):228-233. [DOI] [PubMed] [Google Scholar] source
    • cites [6] 6. Dalal MR, Grabner M, Bonine N, Stephenson JJ, DiGenio A, Bieszk N. Are patients on basal insulin attaining glycemic targets? Characteristics and goal achievement of patients with type 2 diabetes mellitus treated with basal insulin and physician-perceived barriers to achieving glycemic targets. Diabetes Res Clin Pract. 2016;121:17-26. [DOI] [PubMed] [Google Scholar] source
    • cites [25] 25. Schmittdiel JA, Uratsu CS, Karter AJ, et al. Why don’t diabetes patients achieve recommended risk factor targets? Poor adherence versus lack of treatment intensification. J Gen Intern Med. 2008;23(5):588-594. [DOI] [PMC free article] [PubMed] [Google Scholar] source

      The Results (page unavailable) report that 53% of patients not using insulin at baseline had an above-target A1c at some point in 2005. The Methods define above target as A1c ≥7.0%, but the Data Analyses section says the hyperglycemia analysis was limited to patients not on insulin at baseline. The paper therefore supports the general point about missed A1c targets, not the claim specifically about patients receiving basal insulin. (LLM, conf=0.88)

      Experimental — accuracy not yet measured

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

    Premisecitation
    § Introduction

    A recent pilot study using this device reported improvement in glycemic control, reduction in glycemic variability, and improved adherence and satisfaction in patients with type 1 diabetes.

    “A recent pilot study using this device reported improvement in glycemic control, reduction in glycemic variability, and improved adherence and satisfaction in patients with type 1 diabetes. 20”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [20] 20. Gomez-Peralta F, Abreu C, Gomez-Rodriguez S, et al. Efficacy of insulclock in patients with poorly controlled type 1 diabetes mellitus: a pilot, randomized clinical trial. Diabetes Technol Ther. 2020;22(9):686-690. [DOI] [PMC free article] [PubMed] [Google Scholar] source

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

    Premisecitation
    § Discussion

    In a recent survey, the most common factor to reduce insulin discontinuation was increased staff support and feedback from the healthcare team.

    “In a recent survey, the most common factor to reduce insulin discontinuation was increased staff support and feedback from healthcare team. 26”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [26] 26. Roborel de Climens A, Pain E, Boss A, Shaunik A. Understanding reasons for treatment discontinuation, attitudes and education needs among people who discontinue type 2 diabetes treatment: results from an online patient survey in the USA and UK. Diabetes Ther. 2020;11(8):1873-1881. [DOI] [PMC free article] [PubMed] [Google Scholar] source

  • The quote only partly states this claim.

    Findingown data
    § Results

    In insulin-treated patients with poorly controlled type 2 diabetes, the active phase resulted in a greater reduction in mean daily blood glucose from baseline compared to the control phase (−9.32 ± 32 mg/dl vs −2.75 mg/dl, P = .008).

    “Overall, there was a significant difference in mean daily blood glucose reduction from baseline in the active vs. control phase (−9.32 ± 32 mg/dl vs −2.75 mg/dl, P = .008).”
    Quote in the paperSubstantial claim

  • The quote only partly states this claim.

    Findingown data
    § Results

    In insulin-treated patients with poorly controlled type 2 diabetes, the active phase resulted in a greater reduction in mean fasting blood glucose from baseline compared to the control phase (P = .02).

    “Similar findings were observed on mean fasting blood glucose with a significant difference in blood glucose reduction from baseline in the active vs. control phase (P = .02).”
    Quote in the paperSubstantial claim

  • The quote only partly states this claim.

    Findingown data
    § Results

    In insulin-treated patients with poorly controlled type 2 diabetes, patients were equally satisfied with the device during the active and control phases, with total DTSQc scores of 15.5 ± 3.7 and 14.9 ± 3.6/18 points, respectively.

    “Overall, patients were equally satisfied with the device during active and control phase, with a total DTSQc score of 15.5 ± 3.7 and 14.9 ± 3.6/18 points, respectively.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § Abstract

    In insulin-treated patients with poorly controlled type 2 diabetes, there were no significant differences between the active and control phases in treatment adherence, insulin omission, or insulin mistiming.

    “however, no significant differences in treatment adherence, insulin omission or insulin mistiming were observed.”
    Quote in the paperSubstantial claim

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

    Interpretationreasoning
    § Introduction

    There is a need for novel strategies and tools to increase adherence to prescribed insulin regimens.

    “Thus, there is a need for novel strategies and tools to increase adherence to prescribed insulin regimens.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data
    § Discussion

    The difference in HbA1c between the active and control phases was statistically significant but of small clinical relevance.

    “The difference in HbA1c was statistically significant, but of small clinical relevance.”
    Quote in the paperSubstantial claim

  • May combine two claims. The quote only partly states this claim.

    Interpretationown data
    § Results

    In insulin-treated patients with poorly controlled type 2 diabetes, most patients were satisfied with the intervention, and no patients were dissatisfied with the device during follow-up.

    “These results indicate that most patients were satisfied with the intervention. During follow-up, no patients were dissatisfied with the device.”
    Quote in the paperNot a substantial claim

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

    Study design and conductown data
    § Methods

    Randomization was block-stratified by HbA1c ≤8.0% or >8.0%.

    “We conducted a block randomization stratified by HbA1c ≤ 8.0% or >8.0%, with each phase lasting 12 weeks.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Premisecitation
    § Introduction

    The smart insulin pen cap has an alarm system with visual and sound alerts designed to assist preventing insulin omissions and mistiming.

    “The smart insulin pen cap has an alarm system with visual and sound alerts designed to assist preventing insulin omissions and mistiming.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [19] 19. Gomez-Peralta F, Abreu C, Gomez-Rodriguez S, Ruiz L. Insulclock: a novel insulin delivery optimization and tracking system. Diabetes Technol Ther. 2019;21(4):209-214. [DOI] [PubMed] [Google Scholar] source

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

    Premisecitation
    § Introduction

    The Insulclock smart insulin pen cap can be plugged to several brands of insulin pens and tracks date, time, dosage, type of insulin, and temperature range.

    “Insulclock®19 is a smart insulin pen cap plugged to several brands of insulin pen devices to help track date, time and dosage of the last injection, type of insulin used, and temperature range.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [19] 19. Gomez-Peralta F, Abreu C, Gomez-Rodriguez S, Ruiz L. Insulclock: a novel insulin delivery optimization and tracking system. Diabetes Technol Ther. 2019;21(4):209-214. [DOI] [PubMed] [Google Scholar] source

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

    Study design and conductown data
    § Methods

    The study was a pilot, prospective, randomized (1:1), 26-week, cross-over clinical trial in insulin-treated patients with inadequate glycemic control.

    “We conducted a pilot, prospective, randomized (1:1), 26-weeks, cross-over clinical trial in insulin-treated patients with inadequate glycemic control.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data
    § Discussion

    Incorporating a tracking device on insulin administration using smartphone technology was well received by participants, with a tendency towards improved glycemic control measures.

    “Our study indicates that incorporating a tracking device on insulin administration, using smartphone technology, was well received by participants, with a tendency towards improved glycemic control measures.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data
    § Results

    Patients had similar clinical characteristics at baseline, without significant differences in age, ethnicity, BMI, duration of diabetes, annual income, mean baseline glucose, and HbA1c concentration.

    “Patients had similar clinical characteristics at baseline, without significant differences in age, ethnicity, BMI, duration of diabetes, annual income, mean baseline glucose, and HbA1c concentration (Table 1).”
    Quote in the paperSubstantial claim

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

    Study design and conductnone given
    § Methods

    The trial was registered with ClinicalTrials.gov, NCT 03224234.

    “This trial was registered with ClinicalTrials.gov, NCT 03224234.”
    Quote in the paperNot a substantial claim

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

    Study design and conductnone given
    § Methods

    Participants and investigators were not masked to treatment allocation.

    “Participants and investigators were not masked to treatment allocation.”
    Quote in the paperNot a substantial claim
19 of 19

  • The paper relies on this without support.

    The smart insulin pen cap can be added-on to most commercially available insulins in Europe and the United States.

    “While these results are a step forward, most smart insulin pens are not interchangeable among brands, compared to this smart insulin pen cap that can be added-on to most commercially available insulins in Europe and the United States.”

  • The paper relies on this without support.

    Most smart insulin pens are not interchangeable among brands.

    “While these results are a step forward, most smart insulin pens are not interchangeable among brands, compared to this smart insulin pen cap that can be added-on to most commercially available insulins in Europe and the United States.”
2 of 2

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.

  • Blood-glucose value is assigned to opposite phases

    Major

    The abstract assigns approximately 157.6 ± 42 mg/dL to the control/masked phase, whereas the Results identify 157.56 ± 42 mg/dl as the value after 12 weeks in the active phase. This is a conclusion-bearing comparison of glycemic control.

  • Baseline HbA1c values are swapped between treatment sequences

    Major

    Table 1 gives approximately 9.1 ± 1.7% for the active-first group, but the Results assign approximately 9.3 ± 1.3% to that group. The latter values instead match the table's control-first group.

  • Abstract and Results give different control-phase HbA1c reductions

    Minor

    The abstract reports a control-phase reduction of −0.72%, while the Results report −0.70% for the same active-versus-control comparison. Both are printed to two decimal places, so the difference is not ordinary rounding.

3 of 3

Cites

Flagged first, then by citations

Research works printed but not linked: 2

  1. American Diabetes Association, 2020, Diabetes Care, 43
  2. Klausmann G, 2013, Patient Prefer Adherence, 7, 285

Cited by

Sorted by citations

Related

Authors
Galindo, R. J., Ramos, C., Cardona, S., Vellanki, P., Davis, G. M., Oladejo, O., Albury, B., Dhruv, N., Peng, L., & Umpierrez, G. E.
Affiliations
  • Grady Memorial Hospital (US)
  • Emory University (US)
Corresponding author
Umpierrez, Guillermo E.
ORCID
Venue
Journal of Diabetes Science and Technology
Publisher
SAGE Publications
Published
2021-07-22
Volume
17
Issue
1
Pages
201-207
ISSN
1932-2968 (ISSN-L)
DOI
10.1177/19322968211033837
PMC
PMC9846390
OpenAlex
W3183717081
Cited by
40
References
27
Citations by year
2026: 6 · 2025: 10 · 2024: 9 · 2023: 10 · 2022: 4 · 2021: 1
FWCI
3.72
Type
journal article
Language
en
Open access
Licence
journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations
  • Journal of Diabetes Science and Technology (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (submittedVersion)
Funders
Insulcloud, Inc
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 › Health Professions › General Health Professions › Mobile Health and mHealth Applications
Keywords
type 2 diabetes, insulin therapy, medication adherence, glycemic control, HbA1c, smartphone reminders, insulin omission, patient satisfaction, diabetes treatment satisfaction, basal insulin
MeSH terms
Blood Glucose, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Pilot Projects, Cross-Over Studies, Insulin, Regular, Human

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