NCT03772600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 29, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

1.7 years

First QC Date

December 5, 2018

Last Update Submit

December 20, 2022

Conditions

Type 1 Diabetes Mellitus

Keywords

Dexcom G6FreeStyle Libretime in rangecontinuous glucose monitoringflash glucose monitoring

Outcome Measures

Primary Outcomes (1)

  • Difference in time in range (70-180 mg/dL) between the control and experimental group

    measured by Dexcom G6

    6 months

Secondary Outcomes (19)

  • Between group difference in time in clinically important hypoglycemia (<54mg/dL)

    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)

    6 months

  • Between group difference in time in target (70-140 mg/dL)

    6 months

  • +14 more secondary outcomes

Other Outcomes (26)

  • Number of diabetes contacts which are not preplanned

    6 months

  • Resource utilization (cost material, use of extra adhesives)

    6 months

  • Number of severe adverse events

    6 months

  • +23 more other outcomes

Study Arms (2)

Dexcom G6

EXPERIMENTAL

Use a Dexcom G6 CGM for 36 months

Device: Dexcom G6 CGM

FreeStyle Libre

NO INTERVENTION

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.

Interventions

Dexcom G6 CGMDEVICE

Use of Dexcom G6

Dexcom G6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Onze-Lieve-Vrouw Ziekenhuis Aalst

Aalst, 9300, Belgium

Location

Imeldaziekenhuis Bonheiden

Bonheiden, 2820, Belgium

Location

University Hospital Brussels

Jette, 1090, Belgium

Location

AZ Groeninge Kortrijk

Kortrijk, 8500, Belgium

Location

University Hospital Leuven

Leuven, 3000, Belgium

Location

University Hospital Antwerp

Wilrijk, 2650, Belgium

Location

Related Publications (3)

  • Visser MM, Van Muylder A, Charleer S, Isitt JJ, Roze S, De Block C, Maes T, Vanhaverbeke G, Nobels F, Keymeulen B, Mathieu C, Luyten J, Gillard P, Verhaeghe N. Cost-utility analysis of Dexcom G6 real-time continuous glucose monitoring versus FreeStyle Libre 1 intermittently scanned continuous glucose monitoring in adults with type 1 diabetes in Belgium. Diabetologia. 2024 Apr;67(4):650-662. doi: 10.1007/s00125-023-06084-2. Epub 2024 Jan 18.

    PMID: 38236409DERIVED

  • 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. Effect of switching from intermittently scanned to real-time continuous glucose monitoring in adults with type 1 diabetes: 24-month results from the randomised ALERTT1 trial. Lancet Diabetes Endocrinol. 2023 Feb;11(2):96-108. doi: 10.1016/S2213-8587(22)00352-7.

    PMID: 36702566DERIVED

  • 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.

    PMID: 34089660DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: multicenter, randomized, double arm, open label, partial cross-over, parallel group clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 11, 2018

Study Start

January 29, 2019

Primary Completion

October 1, 2020

Study Completion

November 30, 2022

Last Updated

December 21, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

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.

Locations

BE(6)