Clinical trial NCT03772600: Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes
Official title: Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Dexcom G6
FreeStyle Libre
time in range
continuous glucose monitoring
flash glucose monitoring
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2018-12-11
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, randomized, double arm, open label, partial cross-over, parallel group clinical trial
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Difference in time in range (70-180 mg/dL) between the control and experimental group
timeFrame: 6 months
Secondary outcomes:
measure: Between group difference in time in clinically important hypoglycemia (<54mg/dL)
timeFrame: 6 months
measure: Between group difference of HbA1c
timeFrame: 6 months
measure: Between group difference in fear of hypoglycemia measured by the hypoglycemia fear survey
timeFrame: 6 months
measure: Between group difference in time in hypoglycemia (<70 mg/dL)
timeFrame: 6 months
measure: Between group difference in time in target (70-140 mg/dL)
timeFrame: 6 months
measure: Between group difference in time in hyperglycemia (>180 mg/dL)
timeFrame: 6 months
measure: Between group difference in time in clinically important hyperglycemia (>250 mg/dL)
timeFrame: 6 months
measure: Composite endpoint: between group difference in number of patients with HbA1c <7% without episodes of severe hypoglycemia
timeFrame: 6 months
measure: Between group difference in glycemic variability as measured by coefficient of variation [CV]
timeFrame: 6 months
measure: Between group difference in glycemic variability as measured by standard deviation [SD]
timeFrame: 6 months
measure: Between group difference in glycemic variability as measured by mean amplitude of glycemic excursions [MAGE]
timeFrame: 6 months
measure: Between group difference in mean glucose concentration
timeFrame: 6 months
measure: Between group difference in number of low glucose events (LGE)
timeFrame: 6 months
measure: Between group difference in number of severe hypoglycemic episodes
timeFrame: 6 months
measure: Between group difference in emotional distress due to diabetes measured by the problem areas in diabetes (PAID) questionnaire
timeFrame: 6 months
measure: Between group difference in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey
timeFrame: 6 months
measure: Between group difference in treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ)
timeFrame: 6 months
measure: Between group difference in general quality of life measured by the SF-36 questionnaire
timeFrame: 6 months
measure: Between group difference in number of patients having allergic reactions to the sensors
timeFrame: 6 months
Other outcomes:
measure: Number of diabetes contacts which are not preplanned
timeFrame: 6 months
measure: Resource utilization (cost material, use of extra adhesives)
timeFrame: 6 months
measure: Number of severe adverse events
timeFrame: 6 months
measure: Hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis)
timeFrame: 6 months
measure: Work absenteeism due to diabetes
timeFrame: 6 months
measure: Number of patients who stop using the Dexcom G6 CGM and the reason to stop
timeFrame: 6 months
measure: Changes in time in range (70-180 mg/dL)
timeFrame: 36 months (extension phase)
measure: Changes in time in target (70-140 mg/dL)
timeFrame: 36 months (extension phase)
measure: Changes in time in hypoglycemia (<70 mg/dL)
timeFrame: 36 months (extension phase)
measure: Changes in time in clinically important hypoglycemia (<54 mg/dL)
timeFrame: 36 months (extension phase)
measure: Changes in time in hyperglycemia (>180 mg/dL)
timeFrame: 36 months (extension phase)
measure: Changes in time in clinically important hyperglycemia (>250 mg/dL)
timeFrame: 36 months (extension phase)
measure: Changes in time in glycemic variability, defined by coefficient of variation (CV)
timeFrame: 36 months (extension phase)
measure: Changes in time in glycemic variability, defined by standard deviation (SD)
timeFrame: 36 months (extension phase)
measure: Changes in time in glycemic variability, defined by mean amplitude of glycemic excursions (MAGE)
timeFrame: 36 months (extension phase)
measure: 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)
timeFrame: 36 months (extension phase)
measure: Changes in HbA1c
timeFrame: 36 months (extension phase)
measure: Changes in in emotional distress due to diabetes measured by the PAID questionnaire
timeFrame: 36 months (extension phase)
measure: Changes in in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey
timeFrame: 36 months (extension phase)
measure: Changes in treatment satisfaction measured by the DTSQ
timeFrame: 36 months (extension phase)
measure: Changes in general quality of life measured by the SF-36 questionnaire
timeFrame: 36 months (extension phase)
measure: Changes in in fear of hypoglycemia measured by the hypoglycemia fear survey
timeFrame: 36 months (extension phase)
measure: Changes in hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis, expressed as admissions per patient year)
timeFrame: 36 months (extension phase)
measure: Changes in work absenteeism (expressed as days of work absenteeism per patient year)
timeFrame: 36 months (extension phase)
measure: Changes in number of severe hypoglycemic episodes (expressed as number of episodes per patient year)
timeFrame: 36 months (extension phase)
measure: Number of patients who stop using the Dexcom G6® CGM and the reason to stop
timeFrame: 36 months (extension phase)
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouw Ziekenhuis Aalst
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis Bonheiden
city: Jette
country: Belgium
facility: University Hospital Brussels
city: Kortrijk
country: Belgium
facility: AZ Groeninge Kortrijk
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Wilrijk
country: Belgium
facility: University Hospital Antwerp
Study officials:
References:
citation: 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.