Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes

Not Applicable

Completed

• 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

Study Timeline

• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Study Start: 2019-01-29
• Primary Completion: 2020-10-01
• Study Completion: 2022-11-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

• 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 Criteria

• 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