DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy

Inclusion criteria

• Documented T1D for at least 1 year prior to study enrolment
• Subjects aged 18 - 65 years old
• A1c at inclusion ≤ 10%
• Subjects using basal-bolus MDI therapy:

• Basal insulin: Glargine, Degludec, or Determir
• Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues
• Subjects using CGM or SMBG that are compatible with data transmission to the study DMS.
• BMI < 28 kg/m2
• Subjects willing to follow study instructions:

• For SMBG users: measure capillary blood glucose at least 4 times a day and twice a week 7-point profile (optional). Document blood glucose level, insulin delivery, meals and daily activities. Wear blinded CGM.
• For CGM users: Use CGM according to manufacture instructions, Document insulin delivery, meals and daily activities.
• Subjects have connection to the internet at home.
• Subjects have a smartphone 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
• Participation in any other interventional study
• 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.