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Type 1 Diabetes MellitusALERTT1NCT03772600

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

A study testing Dexcom G6 CGM in people with Type 1 Diabetes Mellitus, run by Universitaire Ziekenhuizen KU Leuven at 6 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Dexcom G6 CGM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
6 sitesBelgium
Study dates
29 Jan 2019to 30 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Belgium6 sites

  • Onze-Lieve-Vrouw Ziekenhuis Aalst

    Aalst, 9300

  • Imeldaziekenhuis Bonheiden

    Bonheiden, 2820

  • University Hospital Brussels

    Jette, 1090

  • AZ Groeninge Kortrijk

    Kortrijk, 8500

  • University Hospital Leuven

    Leuven, 3000

  • University Hospital Antwerp

    Wilrijk, 2650

Other trials in Belgium

About this study

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.

Read more

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.

Being tested
Dexcom G6 CGM
Keywords
Dexcom G6, FreeStyle Libre, time in range, continuous glucose monitoring, flash glucose monitoring
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexcom G6 CGMDevice

    Use of Dexcom G6

Study groups in NCT03772600
Study groupRoleWhat they receive
Dexcom G6ExperimentalUse a Dexcom G6 CGM for 36 months
Receives: Device: Dexcom G6 CGM
FreeStyle LibreNo interventionKeep 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 being measured

The primary outcome is the main question the study is designed to answer.

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

    measured by Dexcom G6

    Measured: 6 months

Secondary outcomes (19)

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

    measured by Dexcom G6

    Measured: 6 months

  2. Between group difference of HbA1c

    Measured: 6 months

  3. Between group difference in fear of hypoglycemia measured by the hypoglycemia fear survey

    Measured: 6 months

  4. Between group difference in time in hypoglycemia (<70 mg/dL)

    measured by Dexcom G6

    Measured: 6 months

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

    measured by Dexcom G6

    Measured: 6 months

  6. Between group difference in time in hyperglycemia (>180 mg/dL)

    measured by Dexcom G6

    Measured: 6 months

  7. Between group difference in time in clinically important hyperglycemia (>250 mg/dL)

    measured by Dexcom G6

    Measured: 6 months

  8. Composite endpoint: between group difference in number of patients with HbA1c <7% without episodes of severe hypoglycemia

    Measured: 6 months

  9. Between group difference in glycemic variability as measured by coefficient of variation [CV]

    measured by Dexcom G6

    Measured: 6 months

  10. Between group difference in glycemic variability as measured by standard deviation [SD]

    measured by Dexcom G6

    Measured: 6 months

  11. Between group difference in glycemic variability as measured by mean amplitude of glycemic excursions [MAGE]

    measured by Dexcom G6

    Measured: 6 months

  12. Between group difference in mean glucose concentration

    measured by Dexcom G6

    Measured: 6 months

  13. 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

    Measured: 6 months

  14. Between group difference in number of severe hypoglycemic episodes

    reported by the participant

    Measured: 6 months

  15. Between group difference in emotional distress due to diabetes measured by the problem areas in diabetes (PAID) questionnaire

    Measured: 6 months

  16. Between group difference in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey

    Measured: 6 months

  17. Between group difference in treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ)

    Measured: 6 months

  18. Between group difference in general quality of life measured by the SF-36 questionnaire

    Measured: 6 months

  19. Between group difference in number of patients having allergic reactions to the sensors

    confirmed by a dermatologist

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2018
  2. Study start29 Jan 2019
  3. Primary completion1 Oct 2020
  4. Study completion30 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
multicenter, randomized, double arm, open label, partial cross-over, parallel group clinical trial
Masking
None (open label)
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03772600
Sponsor's protocol ID
S61830
Acronym
ALERTT1
Status last verified
Dec 2022
First submitted
5 Dec 2018
Last updated
21 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Aernouts C, Belde SPW, Lambrechts J, Mertens J, Ledeganck KJ, Francque SM, De Block CEM. Metabolic dysfunction-associated steatotic liver disease is associated with worse time in ranges in type 1 diabetes. Diabetes Obes Metab. 2024 Sep;26(9):3781-3790. doi: 10.1111/dom.15723. Epub 2024 Jun 25.

    PubMed 38924290

  • 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.

    PubMed 38236409

  • 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.

    PubMed 36702566

  • 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.

    PubMed 34089660

Questions about this trial

What is this clinical trial studying?

A study testing Dexcom G6 CGM in people with Type 1 Diabetes Mellitus, run by Universitaire Ziekenhuizen KU Leuven at 6 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in time in range (70-180 mg/dL) between the control and experimental group (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03772600, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.

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