Status:
COMPLETED
Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
DexCom, Inc.
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The present study wants to compare the Dexcom G6® continuous glucose monitoring (CGM) system (experimental group) with the FreeStyle Libre flash glucose monitoring (FGM) system (control group). The A...
Eligibility Criteria
Inclusion
- signed ICF
- diagnosis of type 1 diabetes ≥6 months
- using FreeStyle Libre FGM system ≥6 months
- intensified insulin therapy/insulin pump therapy
- HbA1c ≤10%
- willing to wear the glucose monitoring device \>80% of the time
- willing to download glucose monitoring data at regular intervals
Exclusion
- non-type 1 diabetes participants or diagnosis \<6 months
- participant with T1D not on insulin, or on non-intensified insulin therapy
- pregnancy or planning pregnancy within next 6 months
- severe cognitive dysfunction or other disease which makes sensor use difficult
- current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
- abnormal skin at the anticipated glucose sensor insertion sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo)
- presence of concomitant pathology that might cause edema at the insertion sites (such as heart failure, liver failure, kidney failure defined as eGFR \<30 mL/min \[stage ≥4\])
- beta-cell transplantation and c-peptide positive and/or under immunosuppressive therapy
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT03772600
Start Date
January 29 2019
End Date
November 30 2022
Last Update
December 21 2022
Active Locations (6)
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1
Onze-Lieve-Vrouw Ziekenhuis Aalst
Aalst, Belgium, 9300
2
Imeldaziekenhuis Bonheiden
Bonheiden, Belgium, 2820
3
University Hospital Brussels
Jette, Belgium, 1090
4
AZ Groeninge Kortrijk
Kortrijk, Belgium, 8500