A Smartphone Application to Deliver a Treat-to-Target Insulin Titration Algorithm in Insulin-Naive Patients With Type 2 Diabetes: A Pilot Randomized Controlled Trial

An emerging trend in telemedicine has been the development of health applications (apps) for smartphones. Apps focusing on insulin dose calculators are widely available, but the majority of them may contribute to incorrect dose recommendations that put patients at risk for overdose or hypoglycemic events (1). Published data evaluating the effectiveness of using an app in purposely guiding insulin dose titration among patients with type 2 diabetes mellitus (T2DM) is scarce. In this pilot study, we developed a smartphone app called “Diabetes Pal” and investigated its feasibility to deliver an insulin titration algorithm in insulin-naive T2DM patients. A 24-week, randomized, open-label, parallel-group trial was conducted at the Singapore General Hospital between March 2013 and March 2015. The study was approved by the ethics board of the Singapore Health Services and registered with ClinicalTrials.gov (NCT01950676). Insulin-naive T2DM patients with suboptimal glycemic control (HbA1c ≥7.5% [58 mmol/mol]) despite use of two or more oral glucose-lowering drugs were recruited and randomized in a 1:1 ratio into the intervention and control groups. The randomization list was computer generated with a fixed block size of four within each of five endocrinologists. Treatment allocation codes were concealed in sequentially numbered envelopes that were opened each time a patient was enrolled. Participants received a one-time individual educational session with a diabetes nurse educator. Participants were instructed to start with 10 units of insulin detemir at bedtime, self-monitor fasting blood glucose (FBG) daily, and self-titrate insulin every 3 days using a prescribed algorithm to reach a target FBG of 72–126 mg/dL (4.0–7.0 mmol/L). The algorithm was based on the mean FBG (mFBG) over 3 days; +4 when mFBG exceeded 180 mg/dL (10 mmol/L) and +2 when mFBG was 126–180 mg/dL (7.0–10.0 mmol/L). If FBG was <72 mg/dL (<4.0 mmol/L), the dose was …