Overview

An open label, prospective study that will include up to 48 subjects with Type 1 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 a 8 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 12-14 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

Eligibility

Inclusion Criteria:

• Documented Type 1 or Type 2 Diabetes for at least 1 year prior to study enrolment
• Aged ≥ 14 years
• HbA1c of 7 ≤ 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 (FGM with a reader): 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: 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.