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Completed

NCT Number: NCT03772600

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onze-Lieve-Vrouw Ziekenhuis Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DEXCOM G6 CGM

Device

Use of Dexcom G6

Primary outcomes

  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 outcomes

  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 outcomes

  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: 36 months (extension phase)

    within-group change

  8. Changes in time in target (70-140 mg/dL)

    Time frame: 36 months (extension phase)

    within-group change

  9. Changes in time in hypoglycemia (<70 mg/dL)

    Time frame: 36 months (extension phase)

    within-group change

  10. Changes in time in clinically important hypoglycemia (<54 mg/dL)

    Time frame: 36 months (extension phase)

    within-group change

  11. Changes in time in hyperglycemia (>180 mg/dL)

    Time frame: 36 months (extension phase)

    within-group change

  12. Changes in time in clinically important hyperglycemia (>250 mg/dL)

    Time frame: 36 months (extension phase)

    within-group change

  13. Changes in time in glycemic variability, defined by coefficient of variation (CV)

    Time frame: 36 months (extension phase)

    within-group change

  14. Changes in time in glycemic variability, defined by standard deviation (SD)

    Time frame: 36 months (extension phase)

    within-group change

  15. Changes in time in glycemic variability, defined by mean amplitude of glycemic excursions (MAGE)

    Time frame: 36 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: 36 months (extension phase)

    within-group change

  17. Changes in HbA1c

    Time frame: 36 months (extension phase)

    within-group change

  18. Changes in in emotional distress due to diabetes measured by the PAID questionnaire

    Time frame: 36 months (extension phase)

    within-group change

  19. Changes in in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey

    Time frame: 36 months (extension phase)

    within-group change

  20. Changes in treatment satisfaction measured by the DTSQ

    Time frame: 36 months (extension phase)

    within-group change

  21. Changes in general quality of life measured by the SF-36 questionnaire

    Time frame: 36 months (extension phase)

    within-group change

  22. Changes in in fear of hypoglycemia measured by the hypoglycemia fear survey

    Time frame: 36 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: 36 months (extension phase)

    within-group change

  24. Changes in work absenteeism (expressed as days of work absenteeism per patient year)

    Time frame: 36 months (extension phase)

    within-group change

  25. Changes in number of severe hypoglycemic episodes (expressed as number of episodes per patient year)

    Time frame: 36 months (extension phase)

    within-group change

  26. Number of patients who stop using the Dexcom G6® CGM and the reason to stop

    Time frame: 36 months (extension phase)

    within-group change

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • DexCom, Inc.

Registry information

Acronym: ALERTT1

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Dec 11, 2018
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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