Article

No Effect of Insulin Pen with Memory Function on Glycemic Control in a Patient Cohort with Poorly Controlled Type 1 Diabetes: A Randomized Open-Label Study

Bult Diabetes Centre for Children and Adolescents, Hannover, Germany.
Journal of diabetes science and technology 11/2012; 6(6):1392-7. DOI: 10.1177/193229681200600619
Source: PubMed

ABSTRACT

Background:
Injection compliance is a major problem in patients with type 1 diabetes. Increased compliance with mealtime insulin injections significantly improves metabolic control. Using an insulin pen with memory function might facilitate corrective dosing to avoid postprandial blood glucose peaks and therefore might improve overall glycemic control.

Methods:
This randomized, open-label, 24-week multicenter study evaluated if patients with inadequately controlled type 1 diabetes [hemoglobin A1c (HbA1c) ≥ 8%] who were randomized to use the HumaPen® Memoir™, an insulin pen device with memory function, for their mealtime insulin injections achieved superior glycemic control (HbA1c change from baseline) than patients who used the conventional device HumaPen Luxura™. Hemoglobin A1c, hypoglycemia, and pen acceptance were assessed at baseline and after 12 and 24 weeks.

Results:
Of 263 patients randomized, 257 were eligible for analysis: HumaPen Memoir 129, HumaPen Luxura 128; mean [standard deviation (SD)] baseline HbA1c 9.09% (0.99%); mean (SD) age 39.8 (16.5) years; 87.9% ≥18 years old; and mean (SD) diabetes duration 16.0 (11.2) years. Least square mean (95% confidence interval) changes of HbA1c up to week 24 were not significantly different between the HumaPen Memoir [0.43% (-0.59%,-0.28%)] and the HumaPen Luxura group [0.48% (0.64%, 0.32%); p = .669]. The overall incidence of hypoglycemic episodes did not differ significantly between groups (p = .982). Average satisfaction with insulin delivery was high in both groups.

Conclusions:
In this patient sample, usage of a memory function pen was not associated with superior glycemic control, suggesting that adherence to mealtime injection schedules was not improved in a relevant manner. The memory function might be helpful for specific patient populations only, e.g., children or forgetful patients.

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    ABSTRACT: Missing meal bolus and nonadherence is an important barrier to achieving glycemic goals in type 1 diabetes (T1DM). In this issue of Journal of Diabetes Science and Technology, Danne and coauthors reported the results of a 24-week randomized-controlled study designed to evaluate if using an insulin pen with memory function, the HumaPen® Memoir™, might improve injection compliance and, therefore, overall glycemic control in T1DM. Patients treated with the pen device with memory function improved, albeit nonsignificantly, their mean HbA1c by 0.43%. Among the reasons to justify why this study was not positive, the most important is the high proportion of adult patients included in the study (87.9%)—children and adolescents being under-represented. I am convinced that pen devices with memory function might be helpful for forgetful patients (children, adolescents), as suggested in another recent study.
    Preview · Article · Nov 2012 · Journal of diabetes science and technology
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    ABSTRACT: Adherence to treatment is an important issue in chronic disease management and an indicator of patients' ability to self-manage their condition and treatment. Some drug-dispensing and drug-delivery devices have been designed to support patients' medication-taking behavior by including dose-memory and combined dose-memory and dose-reminder functions, which electronically store, and visually display dose-history information, enabling the patient to review, monitor, and/or be actively reminded about their medication doses.
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