A simple insulin delivery device is a patch on insulin delivery device which provides set basal rates and bolus insulin on demand.

Data of two single-arm studies following the same study protocol were combined. Adults with type 2 diabetes (T2D) with A1c ≥7.0 - ≤11.0% (≥53 - ≤97 mmol/mol) on at least 2 insulin injections per day were enrolled to evaluate the simple insulin delivery device.  The study comprised three periods: baseline (conventional insulin injections), transition and simple insulin delivery device treatment (12-weeks).  Endpoints included: HbA1c, 7-point self-monitored blood glucose (SMBG), total daily dose of insulin (TDD) and body weight (BW).  Safety was assessed by; application site examination, hypoglycaemic episodes and adverse device effects (ADEs). 

There were 28 adults enrolled (age 63 ± 7 years, 86% male, BMI 32.3 ± 4.3 kg/m2, T2D duration 17 ± 8 years, HbA1c 8.6 ± 1.1%, TDD 58.7 ± 20.7 U) and 24 completed the study. When transitioned to a simple insulin delivery device, 71% of participants continued on the first basal rate selected.  After 12 weeks of simple insulin delivery significant reductions from baseline were seen in HbA1c -1.5 ± 0.85% (p<0.0001) and 7-point SMBG values; there was a slight increase in TDD (12.1 ± 19.5 U; P=0.0058) and increase in daily meal time bolus doses (0.9 ± 1.5; P=0.0081). Body weight remained stable compared to baseline. Six participants had mild to moderate catheter site reactions and one had mild skin irritation. No participant experienced severe hypoglycaemia.    

Adults with T2D were safely transitioned from insulin injections to simple insulin delivery and achieved significantly improved glycaemic control without increase in hypoglyacemia.

3 month treatment with a simple 3-day insulin delivery device in adults with type 2 diabetes