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

Universitaire Ziekenhuizen KU Leuven269 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

269

Conditions

Type 1 Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

measured by Dexcom G6

Time frame: 6 months

Secondary Outcomes

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

measured by Dexcom G6

Time frame: 6 months

Between group difference of HbA1c

Time frame: 6 months

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

Time frame: 6 months

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

measured by Dexcom G6

Time frame: 6 months

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

measured by Dexcom G6

Time frame: 6 months

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

measured by Dexcom G6

Time frame: 6 months

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

measured by Dexcom G6

Time frame: 6 months

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

Time frame: 6 months

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

measured by Dexcom G6

Time frame: 6 months

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

measured by Dexcom G6

Time frame: 6 months

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

measured by Dexcom G6

Time frame: 6 months

Between group difference in mean glucose concentration

measured by Dexcom G6

Time frame: 6 months

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

Time frame: 6 months

Between group difference in number of severe hypoglycemic episodes

reported by the participant

Time frame: 6 months

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

Time frame: 6 months

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

Time frame: 6 months

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

Time frame: 6 months

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

Time frame: 6 months

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

confirmed by a dermatologist

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes