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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772600
Recruitment Status : Active, not recruiting
First Posted : December 11, 2018
Last Update Posted : June 5, 2020
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
prof dr Pieter Gillard, Universitaire Ziekenhuizen Leuven

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 18 months. The initial experimental group will keep using the unblinded Dexcom G6® for the next 18 months.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: Dexcom G6 CGM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicenter, randomized, double arm, open label, partial cross-over, parallel group clinical trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes
Actual Study Start Date : January 29, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Dexcom G6
Use a Dexcom G6 CGM for 24 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 18 months.




Primary Outcome Measures :
  1. Difference in time in range (70-180 mg/dL) between the control and experimental group [ Time Frame: 6 months ]
    measured by Dexcom G6


Secondary Outcome Measures :
  1. Between group difference in time in clinically important hypoglycemia (<54mg/dL) [ Time Frame: 6 months ]
    measured by Dexcom G6

  2. Between group difference of HbA1c [ Time Frame: 6 months ]
  3. Between group difference in fear of hypoglycemia measured by the hypoglycemia fear survey [ Time Frame: 6 months ]
  4. Between group difference in time in hypoglycemia (<70 mg/dL) [ Time Frame: 6 months ]
    measured by Dexcom G6

  5. Between group difference in time in target (70-140 mg/dL) [ Time Frame: 6 months ]
    measured by Dexcom G6

  6. Between group difference in time in hyperglycemia (>180 mg/dL) [ Time Frame: 6 months ]
    measured by Dexcom G6

  7. Between group difference in time in clinically important hyperglycemia (>250 mg/dL) [ Time Frame: 6 months ]
    measured by Dexcom G6

  8. Composite endpoint: between group difference in number of patients with HbA1c <7% without episodes of severe hypoglycemia [ Time Frame: 6 months ]
  9. Between group difference in glycemic variability as measured by coefficient of variation [CV] [ Time Frame: 6 months ]
    measured by Dexcom G6

  10. Between group difference in glycemic variability as measured by standard deviation [SD] [ Time Frame: 6 months ]
    measured by Dexcom G6

  11. Between group difference in glycemic variability as measured by mean amplitude of glycemic excursions [MAGE] [ Time Frame: 6 months ]
    measured by Dexcom G6

  12. Between group difference in mean glucose concentration [ Time Frame: 6 months ]
    measured by Dexcom G6

  13. 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

  14. Between group difference in number of severe hypoglycemic episodes [ Time Frame: 6 months ]
    reported by the participant

  15. Between group difference in emotional distress due to diabetes measured by the problem areas in diabetes (PAID) questionnaire [ Time Frame: 6 months ]
  16. Between group difference in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey [ Time Frame: 6 months ]
  17. Between group difference in treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ) [ Time Frame: 6 months ]
  18. Between group difference in general quality of life measured by the SF-36 questionnaire [ Time Frame: 6 months ]
  19. Between group difference in number of patients having allergic reactions to the sensors [ Time Frame: 6 months ]
    confirmed by a dermatologist


Other Outcome Measures:
  1. Number of diabetes contacts which are not preplanned [ Time Frame: 6 months ]
  2. Resource utilization (cost material, use of extra adhesives) [ Time Frame: 6 months ]
  3. Number of severe adverse events [ Time Frame: 6 months ]
  4. Hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis) [ Time Frame: 6 months ]
  5. Work absenteeism due to diabetes [ Time Frame: 6 months ]
  6. Number of patients who stop using the Dexcom G6 CGM and the reason to stop [ Time Frame: 6 months ]
  7. Changes in time in range (70-180 mg/dL) [ Time Frame: 24 months (extension phase) ]
    within-group change

  8. Changes in time in target (70-140 mg/dL) [ Time Frame: 24 months (extension phase) ]
    within-group change

  9. Changes in time in hypoglycemia (<70 mg/dL) [ Time Frame: 24 months (extension phase) ]
    within-group change

  10. Changes in time in clinically important hypoglycemia (<54 mg/dL) [ Time Frame: 24 months (extension phase) ]
    within-group change

  11. Changes in time in hyperglycemia (>180 mg/dL) [ Time Frame: 24 months (extension phase) ]
    within-group change

  12. Changes in time in clinically important hyperglycemia (>250 mg/dL) [ Time Frame: 24 months (extension phase) ]
    within-group change

  13. Changes in time in glycemic variability, defined by coefficient of variation (CV) [ Time Frame: 24 months (extension phase) ]
    within-group change

  14. Changes in time in glycemic variability, defined by standard deviation (SD) [ Time Frame: 24 months (extension phase) ]
    within-group change

  15. Changes in time in glycemic variability, defined by mean amplitude of glycemic excursions (MAGE) [ Time Frame: 24 months (extension phase) ]
    within-group change

  16. 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: 24 months (extension phase) ]
    within-group change

  17. Changes in HbA1c [ Time Frame: 24 months (extension phase) ]
    within-group change

  18. Changes in in emotional distress due to diabetes measured by the PAID questionnaire [ Time Frame: 24 months (extension phase) ]
    within-group change

  19. Changes in in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey [ Time Frame: 24 months (extension phase) ]
    within-group change

  20. Changes in treatment satisfaction measured by the DTSQ [ Time Frame: 24 months (extension phase) ]
    within-group change

  21. Changes in general quality of life measured by the SF-36 questionnaire [ Time Frame: 24 months (extension phase) ]
    within-group change

  22. Changes in in fear of hypoglycemia measured by the hypoglycemia fear survey [ Time Frame: 24 months (extension phase) ]
    within-group change

  23. Changes in hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis, expressed as admissions per patient year) [ Time Frame: 24 months (extension phase) ]
    within-group change

  24. Changes in work absenteeism (expressed as days of work absenteeism per patient year) [ Time Frame: 24 months (extension phase) ]
    within-group change

  25. Changes in number of severe hypoglycemic episodes (expressed as number of episodes per patient year) [ Time Frame: 24 months (extension phase) ]
    within-group change

  26. Number of patients who stop using the Dexcom G6® CGM and the reason to stop [ Time Frame: 24 months (extension phase) ]
    within-group change



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772600


Locations
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Belgium
Onze-Lieve-Vrouw Ziekenhuis Aalst
Aalst, Belgium, 9300
Imeldaziekenhuis Bonheiden
Bonheiden, Belgium, 2820
University Hospital Brussels
Jette, Belgium, 1090
AZ Groeninge Kortrijk
Kortrijk, Belgium, 8500
University Hospital Leuven
Leuven, Belgium, 3000
University Hospital Antwerp
Wilrijk, Belgium, 2650
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
DexCom, Inc.
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Responsible Party: prof dr Pieter Gillard, Prof Dr, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03772600    
Other Study ID Numbers: S61830
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by prof dr Pieter Gillard, Universitaire Ziekenhuizen Leuven:
Dexcom G6
FreeStyle Libre
time in range
continuous glucose monitoring
flash glucose monitoring
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases