Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility and Proof of Concept Studies
The study comprises of two segments: a feasibility segment and a Proof of Concept segment. The study is open label, prospective study that will include up to 72 subjects in segment 1 and up to 40 subjects in segment 2. Participants are people with Type 1 or type 2 Diabetes treated with Multiple Daily Injections ( MDI) and Self Monitoring of Blood Glucose (SMBG) or intermittent Continuous Glucose Monitoring (CGM). The study will include screening, a 2-4-week run-in period and 10-12 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps ) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 12-16 weeks. The goal of this study is to evaluate the safety of a decision support system for adjustment of insulin treatment plan for people with diabetes using multiple daily injections and monitoring glucose by SMBG or intermittent CGM
• Documented Type 1 or Type 2 Diabetes for at least 1 year prior to study enrolment
• Aged ≥ 14 years
• HbA1c of 6.5 ≤ A1c ≤ 10%
• Using basal-bolus MDI therapy:
‣ Basal insulin: Glargine, Degludec, or detemir and up to sum of 72 units of basal insulin
⁃ Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues
• Subjects willing to follow study instructions:
‣ For SMBG users (only for segment 1): measure capillary blood glucose at least 4 times a day . Document blood glucose level, insulin delivery, meals and daily activities. Wear CGM.
⁃ For CGM users (FGM with a reader or real-time CGM): Use CGM according to manufacture instructions, document insulin delivery, meals and daily activities.
• Subjects using CGM or SMBG that are compatible with data transmission to the study diabetes management system (i.e. for CGM, FGM with a reader).
• Fasting glucose target is \< = 180 mg/dl (T2D)
• Subjects have home computer connected to the internet.
• Subjects have a smart phone compatible with study requirements.
• Subjects willing and able to sign a written informed consent form.