Status:
TERMINATED
Determination of Automated Multiple Insulin Dose Injections Settings Using the MDI/SMBG Advisor for Patients With Type 1 Diabetes -Data Collection, Observational & Proof of Concept Study
Lead Sponsor:
Rabin Medical Center
Collaborating Sponsors:
DreaMed
Harvard University
Conditions:
Type 1 Diabetes
Multiple Daily Injections
Eligibility:
All Genders
14-30 years
Phase:
NA
Brief Summary
The MDI (Multiple Daily Injections) plus SMBG \|(Self Monitoring Blood Glucose) Advisor (MPSA) is a software product that is designed to assist in insulin dosage decision making for subjects with T1DM...
Eligibility Criteria
Inclusion
- Documented T1D for at least 1 year prior to study enrolment
- Subjects aged ≥ 14 years and up to 30 years
- A1c at inclusion ≥ 7 % and ≤ 10%
- Using MDI of Basal/bolus therapy - basal insulin either Glargine/Lantus or Tregludec insulin and bolus short acting insulin analogs either aspart/Novorapid or Lispro/Humalog
- Using SMBG or flash glucose monitoring (FGM/Libre) without using glucose trends
- BMI SDS - below the 97th percentile for age
- Subjects willing to follow study instructions
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
- Participation in any other interventional study
- Known or suspected allergy to trial products
- Female subject who is pregnant or planning to become pregnant within the planned study duration
- Subject needs to travel by air during the study duration
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04014569
Start Date
May 2 2018
End Date
September 1 2020
Last Update
December 1 2020
Active Locations (1)
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1
Schnider children medical center
Petah Tikva, Israel