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Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes (ALERTT1)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Dexcom G6 CGM
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring Dexcom G6, FreeStyle Libre, time in range, continuous glucose monitoring, flash glucose monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Onze-Lieve-Vrouw Ziekenhuis Aalst
  • Imeldaziekenhuis Bonheiden
  • University Hospital Brussels
  • AZ Groeninge Kortrijk
  • University Hospital Leuven
  • University Hospital Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dexcom G6

FreeStyle Libre

Arm Description

Use a Dexcom G6 CGM for 36 months

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.

Outcomes

Primary Outcome Measures

Difference in time in range (70-180 mg/dL) between the control and experimental group
measured by Dexcom G6

Secondary Outcome Measures

Between group difference in time in clinically important hypoglycemia (<54mg/dL)
measured by Dexcom G6
Between group difference of HbA1c
Between group difference in fear of hypoglycemia measured by the hypoglycemia fear survey
Between group difference in time in hypoglycemia (<70 mg/dL)
measured by Dexcom G6
Between group difference in time in target (70-140 mg/dL)
measured by Dexcom G6
Between group difference in time in hyperglycemia (>180 mg/dL)
measured by Dexcom G6
Between group difference in time in clinically important hyperglycemia (>250 mg/dL)
measured by Dexcom G6
Composite endpoint: between group difference in number of patients with HbA1c <7% without episodes of severe hypoglycemia
Between group difference in glycemic variability as measured by coefficient of variation [CV]
measured by Dexcom G6
Between group difference in glycemic variability as measured by standard deviation [SD]
measured by Dexcom G6
Between group difference in glycemic variability as measured by mean amplitude of glycemic excursions [MAGE]
measured by Dexcom G6
Between group difference in mean glucose concentration
measured by Dexcom G6
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
Between group difference in number of severe hypoglycemic episodes
reported by the participant
Between group difference in emotional distress due to diabetes measured by the problem areas in diabetes (PAID) questionnaire
Between group difference in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey
Between group difference in treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ)
Between group difference in general quality of life measured by the SF-36 questionnaire
Between group difference in number of patients having allergic reactions to the sensors
confirmed by a dermatologist

Full Information

First Posted
December 5, 2018
Last Updated
December 20, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
DexCom, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03772600
Brief Title
Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes
Acronym
ALERTT1
Official Title
Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
DexCom, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Dexcom G6, FreeStyle Libre, time in range, continuous glucose monitoring, flash glucose monitoring

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multicenter, randomized, double arm, open label, partial cross-over, parallel group clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
269 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexcom G6
Arm Type
Experimental
Arm Description
Use a Dexcom G6 CGM for 36 months
Arm Title
FreeStyle Libre
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dexcom G6 CGM
Intervention Description
Use of Dexcom G6
Primary Outcome Measure Information:
Title
Difference in time in range (70-180 mg/dL) between the control and experimental group
Description
measured by Dexcom G6
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Between group difference in time in clinically important hypoglycemia (<54mg/dL)
Description
measured by Dexcom G6
Time Frame
6 months
Title
Between group difference of HbA1c
Time Frame
6 months
Title
Between group difference in fear of hypoglycemia measured by the hypoglycemia fear survey
Time Frame
6 months
Title
Between group difference in time in hypoglycemia (<70 mg/dL)
Description
measured by Dexcom G6
Time Frame
6 months
Title
Between group difference in time in target (70-140 mg/dL)
Description
measured by Dexcom G6
Time Frame
6 months
Title
Between group difference in time in hyperglycemia (>180 mg/dL)
Description
measured by Dexcom G6
Time Frame
6 months
Title
Between group difference in time in clinically important hyperglycemia (>250 mg/dL)
Description
measured by Dexcom G6
Time Frame
6 months
Title
Composite endpoint: between group difference in number of patients with HbA1c <7% without episodes of severe hypoglycemia
Time Frame
6 months
Title
Between group difference in glycemic variability as measured by coefficient of variation [CV]
Description
measured by Dexcom G6
Time Frame
6 months
Title
Between group difference in glycemic variability as measured by standard deviation [SD]
Description
measured by Dexcom G6
Time Frame
6 months
Title
Between group difference in glycemic variability as measured by mean amplitude of glycemic excursions [MAGE]
Description
measured by Dexcom G6
Time Frame
6 months
Title
Between group difference in mean glucose concentration
Description
measured by Dexcom G6
Time Frame
6 months
Title
Between group difference in number of low glucose events (LGE)
Description
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
Time Frame
6 months
Title
Between group difference in number of severe hypoglycemic episodes
Description
reported by the participant
Time Frame
6 months
Title
Between group difference in emotional distress due to diabetes measured by the problem areas in diabetes (PAID) questionnaire
Time Frame
6 months
Title
Between group difference in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey
Time Frame
6 months
Title
Between group difference in treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ)
Time Frame
6 months
Title
Between group difference in general quality of life measured by the SF-36 questionnaire
Time Frame
6 months
Title
Between group difference in number of patients having allergic reactions to the sensors
Description
confirmed by a dermatologist
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Number of diabetes contacts which are not preplanned
Time Frame
6 months
Title
Resource utilization (cost material, use of extra adhesives)
Time Frame
6 months
Title
Number of severe adverse events
Time Frame
6 months
Title
Hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis)
Time Frame
6 months
Title
Work absenteeism due to diabetes
Time Frame
6 months
Title
Number of patients who stop using the Dexcom G6 CGM and the reason to stop
Time Frame
6 months
Title
Changes in time in range (70-180 mg/dL)
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in time in target (70-140 mg/dL)
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in time in hypoglycemia (<70 mg/dL)
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in time in clinically important hypoglycemia (<54 mg/dL)
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in time in hyperglycemia (>180 mg/dL)
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in time in clinically important hyperglycemia (>250 mg/dL)
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in time in glycemic variability, defined by coefficient of variation (CV)
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in time in glycemic variability, defined by standard deviation (SD)
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in time in glycemic variability, defined by mean amplitude of glycemic excursions (MAGE)
Description
within-group change
Time Frame
36 months (extension phase)
Title
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)
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in HbA1c
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in in emotional distress due to diabetes measured by the PAID questionnaire
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in treatment satisfaction measured by the DTSQ
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in general quality of life measured by the SF-36 questionnaire
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in in fear of hypoglycemia measured by the hypoglycemia fear survey
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis, expressed as admissions per patient year)
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in work absenteeism (expressed as days of work absenteeism per patient year)
Description
within-group change
Time Frame
36 months (extension phase)
Title
Changes in number of severe hypoglycemic episodes (expressed as number of episodes per patient year)
Description
within-group change
Time Frame
36 months (extension phase)
Title
Number of patients who stop using the Dexcom G6® CGM and the reason to stop
Description
within-group change
Time Frame
36 months (extension phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Onze-Lieve-Vrouw Ziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Imeldaziekenhuis Bonheiden
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
University Hospital Brussels
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
AZ Groeninge Kortrijk
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University Hospital Antwerp
City
Wilrijk
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymous data can be shared with participating centers, based on research questions mentioned in this protocol or based on a new study protocol approved by the relevant ethical committees.
Citations:
PubMed Identifier
34089660
Citation
Visser MM, Charleer S, Fieuws S, De Block C, Hilbrands R, Van Huffel L, Maes T, Vanhaverbeke G, Dirinck E, Myngheer N, Vercammen C, Nobels F, Keymeulen B, Mathieu C, Gillard P. Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes (ALERTT1): a 6-month, prospective, multicentre, randomised controlled trial. Lancet. 2021 Jun 12;397(10291):2275-2283. doi: 10.1016/S0140-6736(21)00789-3. Epub 2021 Jun 2.
Results Reference
derived

Learn more about this trial

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

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