Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility and Proof of Concept Studies

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

Inclusion Criteria:

• 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:

  1. Basal insulin: Glargine, Degludec, or detemir and up to sum of 72 units of basal insulin
  2. Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues

• Subjects willing to follow study instructions:

  1. 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.
  2. 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.

Exclusion Criteria:

• An episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment.

• Concomitant diseases/ treatment that influence metabolic control or any significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patients' safety

• Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:

  • Subject has unstable or rapidly progressive renal disease or is receiving dialysis
  • Subject has active proliferative retinopathy
  • Active gastroparesis
  • Subject has loss of kidney function as measured by estimated Glomerular Filtration Rate (eGFR) <45 in the previous 3 months 4. Participation in any other interventional study 5. Female subject who is pregnant or planning to become pregnant within the planned study duration

• Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.

• Drug or alcohol abuse.