Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes
NCT ID: NCT03772600
Last Updated: 2022-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
269 participants
INTERVENTIONAL
2019-01-29
2022-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dexcom G6
Use a Dexcom G6 CGM for 36 months
Dexcom G6 CGM
Use of Dexcom G6
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexcom G6 CGM
Use of Dexcom G6
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
DexCom, Inc.
INDUSTRY
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
prof dr Pieter Gillard
Prof Dr
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S61830
Identifier Type: -
Identifier Source: org_study_id