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

December 20, 2022 updated by: prof dr Pieter Gillard, Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
269

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Onze-Lieve-vrouw Ziekenhuis Aalst
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis Bonheiden
      • Jette, Belgium, 1090
        • University Hospital Brussels
      • Kortrijk, Belgium, 8500
        • AZ Groeninge Kortrijk
      • Leuven, Belgium, 3000
        • University Hospital Leuven
      • Wilrijk, Belgium, 2650
        • University Hospital Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dexcom G6
Use a Dexcom G6 CGM for 36 months
Device: Dexcom G6 CGM
Use of Dexcom G6
No Intervention: FreeStyle Libre

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?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in time in range (70-180 mg/dL) between the control and experimental group
Time Frame: 6 months
measured by Dexcom G6
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Between group difference in time in clinically important hypoglycemia (<54mg/dL)
Time Frame: 6 months
measured by Dexcom G6
6 months
Between group difference of HbA1c
Time Frame: 6 months
6 months
Between group difference in fear of hypoglycemia measured by the hypoglycemia fear survey
Time Frame: 6 months
6 months
Between group difference in time in hypoglycemia (<70 mg/dL)
Time Frame: 6 months
measured by Dexcom G6
6 months
Between group difference in time in target (70-140 mg/dL)
Time Frame: 6 months
measured by Dexcom G6
6 months
Between group difference in time in hyperglycemia (>180 mg/dL)
Time Frame: 6 months
measured by Dexcom G6
6 months
Between group difference in time in clinically important hyperglycemia (>250 mg/dL)
Time Frame: 6 months
measured by Dexcom G6
6 months
Composite endpoint: between group difference in number of patients with HbA1c <7% without episodes of severe hypoglycemia
Time Frame: 6 months
6 months
Between group difference in glycemic variability as measured by coefficient of variation [CV]
Time Frame: 6 months
measured by Dexcom G6
6 months
Between group difference in glycemic variability as measured by standard deviation [SD]
Time Frame: 6 months
measured by Dexcom G6
6 months
Between group difference in glycemic variability as measured by mean amplitude of glycemic excursions [MAGE]
Time Frame: 6 months
measured by Dexcom G6
6 months
Between group difference in mean glucose concentration
Time Frame: 6 months
measured by Dexcom G6
6 months
Between group difference in number of low glucose events (LGE)
Time Frame: 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
6 months
Between group difference in number of severe hypoglycemic episodes
Time Frame: 6 months
reported by the participant
6 months
Between group difference in emotional distress due to diabetes measured by the problem areas in diabetes (PAID) questionnaire
Time Frame: 6 months
6 months
Between group difference in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey
Time Frame: 6 months
6 months
Between group difference in treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ)
Time Frame: 6 months
6 months
Between group difference in general quality of life measured by the SF-36 questionnaire
Time Frame: 6 months
6 months
Between group difference in number of patients having allergic reactions to the sensors
Time Frame: 6 months
confirmed by a dermatologist
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of diabetes contacts which are not preplanned
Time Frame: 6 months
6 months
Resource utilization (cost material, use of extra adhesives)
Time Frame: 6 months
6 months
Number of severe adverse events
Time Frame: 6 months
6 months
Hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis)
Time Frame: 6 months
6 months
Work absenteeism due to diabetes
Time Frame: 6 months
6 months
Number of patients who stop using the Dexcom G6 CGM and the reason to stop
Time Frame: 6 months
6 months
Changes in time in range (70-180 mg/dL)
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in time in target (70-140 mg/dL)
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in time in hypoglycemia (<70 mg/dL)
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in time in clinically important hypoglycemia (<54 mg/dL)
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in time in hyperglycemia (>180 mg/dL)
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in time in clinically important hyperglycemia (>250 mg/dL)
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in time in glycemic variability, defined by coefficient of variation (CV)
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in time in glycemic variability, defined by standard deviation (SD)
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in time in glycemic variability, defined by mean amplitude of glycemic excursions (MAGE)
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
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)
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in HbA1c
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in in emotional distress due to diabetes measured by the PAID questionnaire
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in treatment satisfaction measured by the DTSQ
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in general quality of life measured by the SF-36 questionnaire
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in in fear of hypoglycemia measured by the hypoglycemia fear survey
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis, expressed as admissions per patient year)
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in work absenteeism (expressed as days of work absenteeism per patient year)
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Changes in number of severe hypoglycemic episodes (expressed as number of episodes per patient year)
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)
Number of patients who stop using the Dexcom G6® CGM and the reason to stop
Time Frame: 36 months (extension phase)
within-group change
36 months (extension phase)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
DexCom, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S61830

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

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Locations

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