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

Type 1 Diabetes Mellitus Clinical Trial

— ALERTT1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772600
• Other study ID #: S61830
• Status: Completed
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: November 30, 2022
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• Dexcom G6 CGM
Use of Dexcom G6

Locations

Country	Name	City	State
Belgium	Onze-Lieve-Vrouw Ziekenhuis Aalst	Aalst
Belgium	Imeldaziekenhuis Bonheiden	Bonheiden
Belgium	University Hospital Brussels	Jette
Belgium	AZ Groeninge Kortrijk	Kortrijk
Belgium	University Hospital Leuven	Leuven
Belgium	University Hospital Antwerp	Wilrijk

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	DexCom, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of diabetes contacts which are not preplanned		6 months
Other	Resource utilization (cost material, use of extra adhesives)		6 months
Other	Number of severe adverse events		6 months
Other	Hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis)		6 months
Other	Work absenteeism due to diabetes		6 months
Other	Number of patients who stop using the Dexcom G6 CGM and the reason to stop		6 months
Other	Changes in time in range (70-180 mg/dL)	within-group change	36 months (extension phase)
Other	Changes in time in target (70-140 mg/dL)	within-group change	36 months (extension phase)
Other	Changes in time in hypoglycemia (<70 mg/dL)	within-group change	36 months (extension phase)
Other	Changes in time in clinically important hypoglycemia (<54 mg/dL)	within-group change	36 months (extension phase)
Other	Changes in time in hyperglycemia (>180 mg/dL)	within-group change	36 months (extension phase)
Other	Changes in time in clinically important hyperglycemia (>250 mg/dL)	within-group change	36 months (extension phase)
Other	Changes in time in glycemic variability, defined by coefficient of variation (CV)	within-group change	36 months (extension phase)
Other	Changes in time in glycemic variability, defined by standard deviation (SD)	within-group change	36 months (extension phase)
Other	Changes in time in glycemic variability, defined by mean amplitude of glycemic excursions (MAGE)	within-group change	36 months (extension phase)
Other	Changes in time in number of low glucose events (LGE) (LGE is defined as sensor glucose values =54 mg/dL for at least 20 minutes, preceded by at least 30 minutes with sensor glucose values >54 mg/dL)	within-group change	36 months (extension phase)
Other	Changes in HbA1c	within-group change	36 months (extension phase)
Other	Changes in in emotional distress due to diabetes measured by the PAID questionnaire	within-group change	36 months (extension phase)
Other	Changes in in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey	within-group change	36 months (extension phase)
Other	Changes in treatment satisfaction measured by the DTSQ	within-group change	36 months (extension phase)
Other	Changes in general quality of life measured by the SF-36 questionnaire	within-group change	36 months (extension phase)
Other	Changes in in fear of hypoglycemia measured by the hypoglycemia fear survey	within-group change	36 months (extension phase)
Other	Changes in hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis, expressed as admissions per patient year)	within-group change	36 months (extension phase)
Other	Changes in work absenteeism (expressed as days of work absenteeism per patient year)	within-group change	36 months (extension phase)
Other	Changes in number of severe hypoglycemic episodes (expressed as number of episodes per patient year)	within-group change	36 months (extension phase)
Other	Number of patients who stop using the Dexcom G6® CGM and the reason to stop	within-group change	36 months (extension phase)
Primary	Difference in time in range (70-180 mg/dL) between the control and experimental group	measured by Dexcom G6	6 months
Secondary	Between group difference in time in clinically important hypoglycemia (<54mg/dL)	measured by Dexcom G6	6 months
Secondary	Between group difference of HbA1c		6 months
Secondary	Between group difference in fear of hypoglycemia measured by the hypoglycemia fear survey		6 months
Secondary	Between group difference in time in hypoglycemia (<70 mg/dL)	measured by Dexcom G6	6 months
Secondary	Between group difference in time in target (70-140 mg/dL)	measured by Dexcom G6	6 months
Secondary	Between group difference in time in hyperglycemia (>180 mg/dL)	measured by Dexcom G6	6 months
Secondary	Between group difference in time in clinically important hyperglycemia (>250 mg/dL)	measured by Dexcom G6	6 months
Secondary	Composite endpoint: between group difference in number of patients with HbA1c <7% without episodes of severe hypoglycemia		6 months
Secondary	Between group difference in glycemic variability as measured by coefficient of variation [CV]	measured by Dexcom G6	6 months
Secondary	Between group difference in glycemic variability as measured by standard deviation [SD]	measured by Dexcom G6	6 months
Secondary	Between group difference in glycemic variability as measured by mean amplitude of glycemic excursions [MAGE]	measured by Dexcom G6	6 months
Secondary	Between group difference in mean glucose concentration	measured by Dexcom G6	6 months
Secondary	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
Secondary	Between group difference in number of severe hypoglycemic episodes	reported by the participant	6 months
Secondary	Between group difference in emotional distress due to diabetes measured by the problem areas in diabetes (PAID) questionnaire		6 months
Secondary	Between group difference in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey		6 months
Secondary	Between group difference in treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ)		6 months
Secondary	Between group difference in general quality of life measured by the SF-36 questionnaire		6 months
Secondary	Between group difference in number of patients having allergic reactions to the sensors	confirmed by a dermatologist	6 months