Status:
COMPLETED
Evaluation of Minimed 670G in T1D Patients on Multiple Daily Injection
Lead Sponsor:
Sidra Medicine
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
6-17 years
Brief Summary
Introduction. Sensor Augmented Pump has demonstrated superiority over insulin pump and Multiple Daily Injection (MDI) in achieving optimal glucose control and can improve quality of life in Type 1 Dia...
Detailed Description
This study is a single-arm, single-center, clinical investigation in subjects with Type 1 Diabetes (T1D) on Hybrid Closed Loop (HCL) insulin pump Minimed 670G in a period of 3 months. A total of 30 su...
Eligibility Criteria
Inclusion
- Clinical diagnosis of Type 1 Diabetes. Diagnosis of Type 1 Diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- HbA1c \< 12.5%
- Age 6-17 years at the initiation of the 670G system
- Multiple Daily Injections (Basal Bolus therapy) with Total Daily Insulin use of great than 8.0 units per day over a 1 week period
- Willing and able (access to internet from home) to download information into the Medtronic CareLink software
- Clinically planning to and be able to start the Medtronic 670G HCL system
- History of 3 clinic visits in the last year
Exclusion
- 1\. DKA in the 6 months prior to screening visit
Key Trial Info
Start Date :
February 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 11 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03755479
Start Date
February 1 2019
End Date
August 11 2019
Last Update
September 6 2019
Active Locations (1)
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1
Sidra Medicine
Doha, Qa, Qatar, 26999