Comparison of a novel insulin bolus-patch with pen/syringe injection to deliver mealtime insulin for efficacy, preference, and quality of life in adults with diabetes: a randomized, crossover, multicenter study

Abstract

Objective: This study compared the efficacy, safety, device satisfaction, and quality of life (QOL) in people with diabetes using an insulin bolus-patch versus current devices (pen/syringe) to deliver mealtime insulin.

Research design and methods: Thirty-eight subjects with diabetes (26 with type 1 and 12 with type 2) were randomized to bolus-patch or current injection device (55% pen and 45% syringe) to deliver mealtime insulin in a multicenter, 6-week crossover study. Efficacy was assessed by equivalence in mean daily seven-point blood glucose (MDBG). Safety assessments included severe hypoglycemia episodes, adverse device effects (ADEs), and adverse events (AEs). Device satisfaction was determined by the validated Insulin Delivery System Rating Questionnaire (IDSRQ) and QOL by the validated Diabetes Specific QOL Scale (DSQOLS).

Results: Using bolus-patch, MDBG (mean±SE) was equivalent to that using pen/syringe (8.61±0.28 vs. 9.02±0.26 mmol/L; P=0.098). SD of the seven-point blood glucose measurements was lower using bolus-patch (3.18±0.18 vs. 3.63±0.17 mmol/L; P=0.004), as was the coefficient of variation (CV) (37.2±1.7 vs. 40.3±1.7%; P=0.046). Hemoglobin A1c, 1,5-anhydroglucitol, fructosamine, and insulin use were similar between groups. There were no severe hypoglycemia episodes or serious ADEs. Between-device AEs were comparable. Subjects scored better on six of seven subscales on the DSQOLS and five of six subscales on the IDSRQ while using bolus-patch versus pen/syringe. At study completion, 76% of subjects would choose to switch to bolus-patch (P=0.001).

Conclusions: Delivery of mealtime insulin with bolus-patch compared with pen/syringe resulted in equivalent MDBG, lower SD and CV of seven-point blood glucose measurements, good safety, significant device satisfaction, and improved QOL.

Trial registration: ClinicalTrials.gov NCT01073566.

Figures

FIG. 1.

Insulin bolus-patch (Finesse, Calibra Medical Inc.). (A) Bolus-patch size is 6×3×8 mm. (B) Bolus-patch is wearable for up to 3 days. (C) Mealtime insulin can be dosed through clothing. (D) Mealtime insulin is administered by actuating the buttons on both sides of the bolus-patch.

FIG. 2.

Mean daily blood glucose (in mmol/L) in 38 subjects (intent-to-treat population) by treatment sequence at baseline, the 6-week crossover (end of Phase 1), and the 12-week completion (end of Phase 2). Data are mean±SE values. The mean daily blood glucose was lower by −0.42 mmol/L using bolus-patch versus pen/syringe (P=0.098). *Bolus-patch is Finesse from Calibra Medical Inc.