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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Dexcom G6 CGM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicenter, randomized, double arm, open label, partial cross-over, parallel group clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexcom G6<br>Use a Dexcom G6 CGM for 36 months | Device: Dexcom G6 CGM<br>* Use of Dexcom G6<br>|
| No Intervention: FreeStyle Libre<br>Keep using their FreeStyle Libre for 6 months. Before the 6 month time point is reached, patients will wear a blinded Dexcom G6 for 28 days, together with their FreeStyle Libre. Cross-over to Dexcom G6 for 30 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in time in range (70-180 mg/dL) between the control and experimental group | measured by Dexcom G6 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between group difference in time in clinically important hypoglycemia (<54mg/dL) | measured by Dexcom G6 | 6 months | 
| 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) | measured by Dexcom G6 | 6 months | 
| Between group difference in time in target (70-140 mg/dL) | measured by Dexcom G6 | 6 months | 
| Between group difference in time in hyperglycemia (>180 mg/dL) | measured by Dexcom G6 | 6 months | 
| Between group difference in time in clinically important hyperglycemia (>250 mg/dL) | measured by Dexcom G6 | 6 months | 
| 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] | measured by Dexcom G6 | 6 months | 
| Between group difference in glycemic variability as measured by standard deviation [SD] | measured by Dexcom G6 | 6 months | 
| Between group difference in glycemic variability as measured by mean amplitude of glycemic excursions [MAGE] | measured by Dexcom G6 | 6 months | 
| Between group difference in mean glucose concentration | measured by Dexcom G6 | 6 months | 
| Between group difference in number of low glucose events (LGE) | 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 | 6 months | 
| Between group difference in number of severe hypoglycemic episodes | reported by the participant | 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 general quality of life measured by the SF-36 questionnaire |  | 6 months | 
| Between group difference in number of patients having allergic reactions to the sensors | confirmed by a dermatologist | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexcom G6, FreeStyle Libre, time in range, continuous glucose monitoring, flash glucose monitoring