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Cited by 13Diabetes Treatment and ManagementDiabetes Management and ResearchMedication Adherence and Compliance

Early hypoglycaemia and adherence after basal insulin initiation in a nationally representative sample of Medicare beneficiaries with type 2 diabetes

Open access
Li, Pengxiang, Geng, Zhi, Ladage, Vrushabh P., Wu, Jasmanda, Lorincz, Ilona, Doshi, Jalpa A.·2019·Diabetes, Obesity and Metabolism
DOI 10.1111/dom.13832
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Abstract

Aims: To estimate risk factors associated with early hypoglycaemia and its impact on adherence to and persistence with therapy in Medicare Part D beneficiaries with type 2 diabetes who are initiating basal insulin (BI). Materials and methods: This retrospective analysis used a 5% sample of Medicare files from 2007–2013, identifying beneficiaries with type 2 diabetes initiating BI from 1 January 2008 to 31 December 2012. Early hypoglycaemia was defined as ≥1 hypoglycaemic event ≤6 months postindex. Outcomes included medication adherence and persistence over 12‐ and 36‐month follow‐up. Multivariable logistic and Cox regression analyses were conducted to examine factors associated with early hypoglycaemia and BI adherence/persistence. Results: Of the 14 466 included patients, 1315 (9.1%) experienced hypoglycaemia ≤6 months after initiating BI. Factors associated with early hypoglycaemia were female sex (odds ratio [OR] 1.16 [95% confidence interval [CI] 1.02–1.32]), receipt of a low‐income subsidy under Medicare Part D (OR 1.20 [95% CI 1.01–1.43]), high diabetes complication score index (OR 1.08 [95% CI 1.01–1.15]), and hypoglycaemia during the baseline period (OR 4.24 [95% CI 3.63–4.96]). At 12 months, patients with baseline hypoglycaemia were less likely to be adherent to (OR 0.81 [95% CI 0.70–0.93]) and more likely to discontinue (OR 1.33 [95% CI 1.07–1.66]) their insulin therapy. Results were similar at 36 months. Conclusions: Within 6 months of BI initiation, almost 1 in 10 Medicare Part D beneficiaries experienced hypoglycaemia. Early hypoglycaemia was associated with decreased adherence to BI treatment over 12‐ and 36‐month follow‐up.

AI snapshot

Written from the paper’s full text.

TL;DR

In a 5% Medicare sample of 14,466 beneficiaries with type 2 diabetes initiating basal insulin, 9.1% experienced hypoglycaemia within 6 months. Early hypoglycaemia was associated with lower 12-month adherence and greater discontinuation/persistence gaps over 12 and 36 months.

Key findings

  • Early hypoglycaemia occurred in 1315 of 14,466 patients (9.1%) within 6 months of basal insulin initiation. Factors associated with early hypoglycaemia included female sex (OR 1.16, 95% CI 1.02–1.32), full low-income subsidy status (OR 1.20, 95% CI 1.01–1.43), higher adapted Diabetes Complications Severity Index (OR 1.08, 95% CI 1.01–1.15), and baseline hypoglycaemia (OR 4.24, 95% CI 3.63–4.96).
  • At 12 months, patients with early hypoglycaemia were less likely to be adherent to basal insulin (observed adherence 20.6% vs 25.0%; OR 0.81, 95% CI 0.70–0.93) and more likely to discontinue therapy (observed discontinuation 13.5% vs 10.1%; OR 1.33, 95% CI 1.07–1.66).
  • At 36 months, early hypoglycaemia remained associated with higher odds of insulin discontinuation (OR 1.31, 95% CI 1.03–1.67) and a higher hazard of time to discontinuation (HR 1.22, 95% CI 1.04–1.44); the association with 3-year adherence was not statistically significant (OR 0.84, P = .226).

Methods

  • Retrospective cohort study using a 5% sample of Medicare files from 2007–2013, identifying beneficiaries with type 2 diabetes newly initiating basal insulin from 1 January 2008 to 31 December 2012.
  • Inclusion required continuous Medicare fee-for-service Parts A/B and Part D coverage during baseline and follow-up, ≥1 inpatient or ≥2 outpatient type 2 diabetes claims, and ≥1 oral antidiabetes drug or GLP-1 receptor agonist claim at baseline; exclusions included type 1 diabetes and prior basal insulin claims.
  • Early hypoglycaemia was defined as ≥1 hypoglycaemic event ≤6 months postindex; adherence was measured by proportion of days covered (PDC ≥0.80), and persistence by time to a ≥90-day gap. Multivariable logistic and Cox regression analyses examined factors associated with early hypoglycaemia and adherence/persistence.

Limitations

  • The authors state that adherence and ≥90-day gap measures were based on filled basal insulin claims and did not indicate whether insulin was taken as prescribed; claims also lacked reasons for non-adherence or gaps.
  • The authors state that claims data lack clinical details such as HbA1c and renal function markers, and that claims-based hypoglycaemia is likely underreported because only ICD-9-CM/ICD-10-CM codes associated with healthcare encounters are captured.
  • The authors state that this was observational rather than randomized, so unmeasured confounders could bias estimates; pharmacy claims only capture prescriptions paid by Part D plans, not cash payments or free samples, and the analysis assumed no discarding, hoarding, or wasting of insulin.

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

Integrity signals

Registry

Crossref · 10.1111/dom.13832

Cites

31 of 31 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 17 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    Of 14,466 Medicare beneficiaries with type 2 diabetes initiating basal insulin, 1315 (9.1%) experienced hypoglycaemia within 6 months after initiation.

    “Of the 14 466 included patients, 1315 (9.1%) experienced hypoglycaemia ≤6 months after initiating BI.”
    • Also stated in: § 3.1 | Sample characteristics · plain
      “In this sample, 1315 (9.1%) patients experienced hypoglycaemia during the first 6 months of BI therapy.”
    • Also stated in: § 4 | DISCUSSION · plain
      “We found that early hypoglycaemia occurred in 9.1% of Medicare patients with type 2 diabetes who initiated BI.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The 5% sample of Medicare files is nationally representative of Medicare Part D beneficiaries with type 2 diabetes initiating basal insulin.
  • Findingown data

    There was no statistically significant association between early hypoglycaemia and 3-year adherence (OR 0.84; P = .226).

    “There was no statistically significant association between early hypoglycaemia and 3-year adherence (OR 0.84; P = .226).”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The 5% sample of Medicare files is nationally representative of Medicare Part D beneficiaries with type 2 diabetes initiating basal insulin.
  • Findingown data

    A larger number of inpatient claims with type 2 diabetes as the primary diagnosis is associated with early hypoglycaemia in Medicare beneficiaries with type 2 diabetes initiating basal insulin (P = .003).

    “having a larger number of inpatient claims with type 2 diabetes (P = .003)”
    • Also stated in: § 4 | DISCUSSION · plain
      “The risk for early hypoglycaemia was significantly associated with female sex, LIS status, inpatient resource use, higher aDCSI, presence of connective tissue/rheumatic disease, and hypoglycaemia during the baseline period.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The 5% sample of Medicare files is nationally representative of Medicare Part D beneficiaries with type 2 diabetes initiating basal insulin.
  • Findingown data

    Female sex is associated with early hypoglycaemia in Medicare beneficiaries with type 2 diabetes initiating basal insulin (OR 1.16, 95% CI 1.02-1.32).

    “Factors associated with early hypoglycaemia were female sex (odds ratio [OR] 1.16 [95% confidence interval [CI] 1.02-1.32])”
    • Also stated in: § 3.2 | Factors associated with early hypoglycaemia · plain
      “Baseline factors associated with early hypoglycaemia in the multivariable logistic regression were female sex (P = .026)”
    • Also stated in: § 4 | DISCUSSION · plain
      “The risk for early hypoglycaemia was significantly associated with female sex, LIS status, inpatient resource use, higher aDCSI, presence of connective tissue/rheumatic disease, and hypoglycaemia during the baseline period.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The 5% sample of Medicare files is nationally representative of Medicare Part D beneficiaries with type 2 diabetes initiating basal insulin.
  • Findingown data

    Over 36-month follow-up, patients with early hypoglycaemia had higher odds of insulin discontinuation (OR 1.31, 95% CI 1.03-1.67).

    “Multivariable analysis results over the 36-month follow-up period similarly showed that patients with early hypoglycaemia had higher odds of insulin discontinuation (OR 1.31 [95% CI 1.03-1.67]).”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The 5% sample of Medicare files is nationally representative of Medicare Part D beneficiaries with type 2 diabetes initiating basal insulin.
  • May combine two claims. 5
  • Classified as probably not a substantial claim. 8

  • May combine two claims.

    Findingown data

    Patients who experienced early hypoglycaemia were more likely to have a history of hypoglycaemia and certain co-morbid illnesses during the baseline period.

    “They were also more likely to have a history of hypoglycaemia and co-morbid illnesses (e.g myocardial infarction, congestive heart failure, and peripheral vascular disease, cerebrovascular disease, peptic ulcer disease, and chronic renal disease) during the baseline period.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: The 5% sample of Medicare files is nationally representative of Medicare Part D beneficiaries with type 2 diabetes initiating basal insulin.

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

    Premisecitation

    Among patients with type 2 diabetes who initiate basal insulin, only about 30% achieve their individual glycaemic target, primarily because fear of hypoglycaemia limits proper titration.

    “Among patients with type 2 diabetes who initiate BI, only about 30% achieve their individual glycaemic target, primarily because a fear of hypoglycaemia limits proper titration.10,13”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [10] source

      Not checked in the free run.

    • cites [13] source

      Not checked in the free run.

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

    Premisecitation

    Patients who initiate insulin may experience early hypoglycaemia within 6 months of initiation, which may lead to poor insulin adherence and a higher risk of hospitalization, especially in older and disabled patients.

    “Furthermore, patients who do initiate insulin may experience early hypoglycaemia (ie within 6 months of initiation), which may lead to poor insulin adherence and a higher risk of hospitalization, especially in older and disabled patients.15”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [15] source

      Not checked in the free run.

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

    Study design and conductcitation

    The prescription drug hierarchical condition category (RxHCC) risk score has been used to adjust for potential selection biases in drug-use studies among Medicare patients.

    “prescription drug hierarchical condition category (RxHCC) risk score, 21 which has been used to adjust for potential selection biases in drug-use studies among Medicare patients.[22][23][24]”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [22] source

      Not checked in the free run.

    • cites [23] source

      Not checked in the free run.

    • cites [24] source

      Not checked in the free run.

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

    Premisecitation

    Some factors associated with early hypoglycaemia, such as prior hypoglycaemia, have been associated with hypoglycaemia risk in previous studies.

    “Some of these factors, such as prior hypoglycaemia, have been associated with hypoglycaemia risk in previous studies.26,27”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [26] source

      Not checked in the free run.

    • cites [27] source

      Not checked in the free run.

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

    Study design and conductreasoning

    Pharmacy claims data were only recorded for prescriptions paid for by patients' Part D plans, so claims datasets cannot capture instances when patients paid in cash or received free drug samples.

    “Moreover, pharmacy claims data were only recorded for prescriptions that were paid for by the patients' Part D plans.Claims datasets are, therefore, unable to capture instances when patients paid in cash for their prescription or received free drug samples.”
    Quote in the paperNot a substantial claim

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

    Study design and conductreasoning

    As is the case with all administrative claims database studies, the study did not have information on the reasons for non-adherence or gaps for basal insulin.

    “Furthermore, as is the case with all administrative claims database studies, we did not have information on the reasons for non-adherence or gaps for BI.”
    Quote in the paperNot a substantial claim
    • The authors state this as an assumption: For the purposes of the present study, patients' prescriptions were filled as the drug was needed, and patients were not discarding, hoarding or wasting unused insulin.

  • Probably not a substantial claim: may not pass S2 (checkable), S4 (based).

    Study design and conductnone given

    There is no reason to believe that the rates of missing or unrecorded prescriptions varied significantly between the two comparison groups.

    “Regardless, there is no reason to believe that these rates would have varied significantly between the two comparison groups in our study.”
    Quote in the paperNot a substantial claim

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

    Study design and conductreasoning

    Claims data do not include clinical details and therefore fail to capture important disease indicators, such as HbA1c and renal function markers.

    “Additionally, claims data do not include clinical details and, therefore, fail to capture important disease indicators, such as HbA1c and renal function markers.”
    Quote in the paperNot a substantial claim
9 of 9

  • The paper relies on this without support.

    This study is the first to provide a nationally representative analysis of the Medicare-insured population examining the incidence of hypoglycaemia in new initiators of basal insulin, factors associated with hypoglycaemia, and the association between early hypoglycaemia and adherence/persistence.

    “This study is the first to provide a nationally representative analysis of the Medicare-insured population that examines the incidence of hypoglycaemia in new initiators of BI, factors associated with hypoglycaemia, and the association between early hypoglycaemia and patient adherence to and persistence with treatment.”

  • The paper relies on this without support.

    Limited data exist on factors associated with early hypoglycaemia and its effect on adherence in the Medicare-insured population.

    “However, limited data exist on these issues in the Medicare-insured population.”

  • The paper relies on this without support.

    The 5% sample of Medicare files is nationally representative of Medicare Part D beneficiaries with type 2 diabetes initiating basal insulin.

    “This retrospective analysis used a 5% sample of Medicare files from 2007-2013, identifying beneficiaries with type 2 diabetes initiating BI from 1 January 2008 to 31 December 2012.”
    “This study aimed to address this gap in the literature, using a nationally representative sample of Medicare beneficiaries to (a) examine the incidence and risk factors associated with early hypoglycaemia events in Medicare beneficiaries with type 2 diabetes who are newly initiating BI, and (b) examine the association between early hypoglycaemia and BI treatment adherence and persistence.”

  • The authors state this as an assumption.

    For the purposes of the present study, patients' prescriptions were filled as the drug was needed, and patients were not discarding, hoarding or wasting unused insulin.

    “For the purposes of the present study, it was assumed that patients' prescriptions were filled as the drug was needed, and patients were not discarding, hoarding or wasting unused insulin.”
4 of 4

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Teaching people with diabetes to balance insulin use and carbohydrate intake and physical activity are necessary, but these strategies are not always sufficient for prevention.

    “Teaching people with diabetes to balance insulin use and carbohydrate intake and physical activity are necessary, but these strategies are not always sufficient for prevention (77,(103)(104)(105).”

    From 6. Glycemic Targets: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [77]

  • Some individuals with type 1 diabetes or type 2 diabetes and hypoglycemia who have a fear of hyperglycemia are resistant to relaxation of glycemic targets.

    “Conversely, some individuals with type 1 diabetes or type 2 diabetes and hypoglycemia who have a fear of hyperglycemia are resistant to relaxation of glycemic targets (74)(75)(76)(77)(78)(79)(80)(81)(82)(83).”

    From 6. Glycemic Targets: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [77]

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.

  • Overall White percentage disagrees with Table 1 counts

    Minor

    Table 1 lists 10,215 White patients without early hypoglycaemia and 968 with it. Together, 11,183 of the 14,466 patients are White (77.3%), not 75.64%.

  • Abstract attributes early-hypoglycaemia outcomes to baseline hypoglycaemia

    Minor

    The abstract assigns the 12-month adherence and discontinuation odds ratios to patients with baseline hypoglycaemia. Table 4 identifies those same odds ratios as comparisons of patients with versus without early hypoglycaemia.

  • Conclusion asserts a 36-month adherence association that results do not support

    Minor

    The conclusion says early hypoglycaemia was associated with decreased adherence over both follow-up periods, but the results explicitly report no statistically significant association with 3-year adherence.

3 of 3

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Related

Authors
Li, P., Geng, Z., Ladage, V. P., Wu, J., Lorincz, I., & Doshi, J. A.
Affiliations
  • University of Pennsylvania (US)
  • Sanofi (United States) (US)
  • Hospital of the University of Pennsylvania (US)
Corresponding author
Doshi, Jalpa A.
ORCID
Venue
Diabetes, Obesity and Metabolism
Publisher
Wiley
Published
2019-08-11
Volume
21
Issue
11
Pages
2486-2495
ISSN
  • 1462-8902 (ISSN-L)
  • 1463-1326
DOI
10.1111/dom.13832
OpenAlex
W2959518125
Semantic Scholar
fd7f0c91f03bff8d70286c934277426ac701f3d6
Cited by
13
References
31
Citations by year
2026: 1 · 2024: 2 · 2023: 1 · 2022: 4 · 2021: 1 · 2020: 2 · 2019: 2
FWCI
1.83
Type
journal article
Language
en
Open access
Licence
Locations
  • Diabetes Obesity and Metabolism (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
Funders
Sanofi
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
Keywords
type 2 diabetes, basal insulin, hypoglycemia, medication adherence, treatment persistence, insulin therapy discontinuation, low-income subsidy, sex differences
MeSH terms
Aged, Aged, 80 and over, Diabetes Mellitus, Type 2, Female, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Male, Middle Aged, Retrospective Studies, Risk Factors, United States, Drug Monitoring, Medicare Part D

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