Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility Study
Type1diabetes
About this trial
This is an interventional treatment trial for Type1diabetes
Eligibility Criteria
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:
- 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 (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.
- 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.
Sites / Locations
- schneider children medical center of IsraelRecruiting
- Rabin Medical Center- BelinsonRecruiting
Arms of the Study
Arm 1
Experimental
Intervention
Subject's glucose and insulin data will be transferred to the DreaMed Advisor Pro system. Optimization of insulin treatment plan will be done using the DreaMed Advisor Pro Decision Support System-MDI algorithm. After approval by the study physician (may override the suggestions for safety reasons), the treatment plan will be sent to the subject to be followed for the following 2.5 weeks. The study team will follow-up with a phone call to the subject to verify the subject received the updated treatment plan.