Status:
COMPLETED
Use of Insulin Adjustment Device DreaMed Advisor Pro During Routine Clinical Use for Subjects With Diabetes Type 1
Lead Sponsor:
Rabin Medical Center
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
6-65 years
Phase:
NA
Brief Summary
The DreaMed Advisor Pro, is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing (FDA approved decision support ...
Eligibility Criteria
Inclusion
- Documented Type 1 Diabetes for at least 1 year prior to study enrolment
- Subjects aged 6 - 65 years old
- HbA1c at inclusion ≤ 10%
- Subjects using Insulin pump therapy for at least 4 months
- Subjects using Insulin pump compatible with data transmission to the study Tidepool/Glooko Data Managment System (DMS) - Omnipod, Medtronic
- Subjects using Continuous Glucose Monitoring (CGM) System that is compatible with data transmission to the study Tidepool/Glooko DMS - Dexcom, Libre, Medtronic.
- Subjects willing to follow study instructions: Use CGM according to manufacture instructions, use the bolus-wizard feature of the insulin pump for every meal and correction boluses.
- Subjects have home PC or MAC connected to the internet.
- 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 patient's 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.
- Known or suspected allergy to trial products
- Drug or alcohol abuse
Key Trial Info
Start Date :
February 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04271228
Start Date
February 15 2020
End Date
January 19 2022
Last Update
March 26 2024
Active Locations (1)
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1
Schnider Children's Medical Center
Petah Tikva, Israel, 4920235