Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Device: Dexcom G6 CGM
- Registration Number
- NCT03772600
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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 ALERTT1 trial will have three phases: a baseline, study, and extension phase.
During the baseline phase, eligible patients will be screened for in- and exclusion criteria, wear a blinded Dexcom G6® for 28 days, together with their FreeStyle Libre FGM system, and receive a uniform education moment.
In the study phase, patients will be randomized into two groups (1:1): the experimental group will use an unblinded Dexcom G6® CGM for 6 months, the control group will keep using the FreeStyle Libre FGM system for 6 months. Before the 6 month time point is reached, patients in the control group will wear a blinded Dexcom G6® CGM for 28 days, together with their FreeStyle Libre FGM.
In the extension phase, patients in the initial control group will start using unblinded Dexcom G6® for 30 months. The initial experimental group will keep using the unblinded Dexcom G6® for the next 30 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 269
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexcom G6 Dexcom G6 CGM Use a Dexcom G6 CGM for 36 months
- Primary Outcome Measures
Name Time Method Difference in time in range (70-180 mg/dL) between the control and experimental group 6 months measured by Dexcom G6
- Secondary Outcome Measures
Name Time Method Between group difference in time in clinically important hypoglycemia (<54mg/dL) 6 months measured by Dexcom G6
Between group difference of HbA1c 6 months Between group difference in fear of hypoglycemia measured by the hypoglycemia fear survey 6 months Between group difference in time in hypoglycemia (<70 mg/dL) 6 months measured by Dexcom G6
Between group difference in time in target (70-140 mg/dL) 6 months measured by Dexcom G6
Between group difference in time in hyperglycemia (>180 mg/dL) 6 months measured by Dexcom G6
Between group difference in time in clinically important hyperglycemia (>250 mg/dL) 6 months measured by Dexcom G6
Composite endpoint: between group difference in number of patients with HbA1c <7% without episodes of severe hypoglycemia 6 months Between group difference in glycemic variability as measured by coefficient of variation [CV] 6 months measured by Dexcom G6
Between group difference in glycemic variability as measured by standard deviation [SD] 6 months measured by Dexcom G6
Between group difference in glycemic variability as measured by mean amplitude of glycemic excursions [MAGE] 6 months measured by Dexcom G6
Between group difference in mean glucose concentration 6 months measured by Dexcom G6
Between group difference in number of low glucose events (LGE) 6 months LGE, measured by Dexcom G6, is defined as sensor glucose values ≤54 mg/dL for at least 15 minutes, preceded by at least 30 minutes with sensor glucose values \>54 mg/dL
Between group difference in number of severe hypoglycemic episodes 6 months reported by the participant
Between group difference in general quality of life measured by the SF-36 questionnaire 6 months Between group difference in emotional distress due to diabetes measured by the problem areas in diabetes (PAID) questionnaire 6 months Between group difference in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey 6 months Between group difference in treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ) 6 months Between group difference in number of patients having allergic reactions to the sensors 6 months confirmed by a dermatologist
Trial Locations
- Locations (6)
AZ Groeninge Kortrijk
🇧🇪Kortrijk, Belgium
University Hospital Antwerp
🇧🇪Wilrijk, Belgium
Imeldaziekenhuis Bonheiden
🇧🇪Bonheiden, Belgium
Onze-Lieve-Vrouw Ziekenhuis Aalst
🇧🇪Aalst, Belgium
University Hospital Brussels
🇧🇪Jette, Belgium
University Hospital Leuven
🇧🇪Leuven, Belgium