Status:
COMPLETED
Feasibility of DPP-4 Inhibitor Therapy on Advanced Hybrid Closed Loop System
Lead Sponsor:
Ain Shams University
Conditions:
Time in Range
Eligibility:
All Genders
12-27 years
Phase:
PHASE3
Brief Summary
Background: Ramadan Iftar meal typically causes glucose excursions. Dipeptidyl peptidase-4 inhibitors increase serum concentrations of glucagon-like peptide-1 and thus, decrease blood glucose levels w...
Detailed Description
Current management of people with type 1 diabetes mellitus (T1DM) on intensive insulin therapy recognizes carbohydrates as the most important determinant of postprandial glycaemia; hence, worldwide gu...
Eligibility Criteria
Inclusion
- patients with type 1 diabetes (T1DM )for at least one year
- patients aged 12-27 years
- patients using MiniMed 780G AHCL system (Medtronic, Northridge, CA, USA) at least 6 months before the study
- patients with minimum daily insulin requirement of more than 8 units
- patients willingness and ability to adhere to the study protocol, access to the internet and a computer system that met requirements for uploading the study pump data.
Exclusion
- patients with any microvascular or macrovascular complications
- pregnancy, lactation
- patients who had a point-of-care screening HbA1c \>10.0% (86 mmol/mol)
- patients with hypoglycemic unawareness or recurrent severe hypoglycemic episode in the last 6 months prior to recruitment
- patients with recurrent DKA (more than 2 episodes in the previous 6 months).
- patients with any chronic medical condition, current use of medications (other than insulin) that are known to affect blood glucose level.
- patients who had prior adverse reactions to the adjunctive agent
Key Trial Info
Start Date :
March 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06021119
Start Date
March 23 2023
End Date
April 21 2023
Last Update
September 1 2023
Active Locations (1)
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1
Nancy Elbarbary
Cairo, Egypt, 11361