Status:
COMPLETED
DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy
Lead Sponsor:
DreaMed Diabetes
Conditions:
Insulin-dependent Diabetes Mellitus
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A multi center, open label, prospective study that will include up to 100 subjects with Type 1 Diabetes treated with Multiple Daily Injections (MDI) of insulin according to a predefined sliding scale ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04043260
Start Date
November 27 2019
End Date
April 30 2021
Last Update
August 17 2021
Active Locations (1)
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1
Schneider MC
Petah Tikva, Israel