Status:
COMPLETED
An 8-Day Initiation of Advanced Hybrid Closed Loop System In Children and Adolescents
Lead Sponsor:
Sidra Medicine
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
7-18 years
Brief Summary
One of the available Hybrid closed loop system is MiniMed 670G (Medtronic Diabetes, Northridge, CA, USA), which is indicated for children above 7 years old, adolescents and adults with Type 1 Diabetes...
Detailed Description
This study is a single-arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months. The study will include an 9-month extension phase, to ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of type 1 diabetes \>1 year prior to consent date. 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 7-17 years at the initiation of the 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 able to start the AHCL system
- History of 3 clinic visits in the last year
Exclusion
- DKA in the 6 months prior to screening visit
- Pregnancy
- Untreated diabetes retinopathy, or other causes that ,in the investigator's opinion, precludes the individual from participating in the trial.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04509362
Start Date
October 1 2020
End Date
September 1 2021
Last Update
September 28 2021
Active Locations (1)
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1
Sidra Medicine
Doha, Qa, Qatar, 26999