Type 1 Diabetes Mellitus
Conditions
Keywords
Dexcom G6, FreeStyle Libre, time in range, continuous glucose monitoring, flash glucose monitoring
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.
Interventions
DEVICEDexcom G6 CGM
Use of Dexcom G6
Sponsors
DexCom, Inc.
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
multicenter, randomized, double arm, open label, partial cross-over, parallel group clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in time in range (70-180 mg/dL) between the control and experimental group | 6 months | measured by Dexcom G6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between group difference of HbA1c | 6 months | — |
| Between group difference in fear of hypoglycemia measured by the hypoglycemia fear survey | 6 months | — |
| Between group difference in time in hypoglycemia (<70 mg/dL) | 6 months | measured by Dexcom G6 |
| Between group difference in time in target (70-140 mg/dL) | 6 months | measured by Dexcom G6 |
| Between group difference in time in hyperglycemia (>180 mg/dL) | 6 months | measured by Dexcom G6 |
| Between group difference in time in clinically important hyperglycemia (>250 mg/dL) | 6 months | measured by Dexcom G6 |
| Composite endpoint: between group difference in number of patients with HbA1c <7% without episodes of severe hypoglycemia | 6 months | — |
| Between group difference in glycemic variability as measured by coefficient of variation [CV] | 6 months | measured by Dexcom G6 |
| Between group difference in glycemic variability as measured by standard deviation [SD] | 6 months | measured by Dexcom G6 |
| Between group difference in time in clinically important hypoglycemia (<54mg/dL) | 6 months | measured by Dexcom G6 |
| Between group difference in mean glucose concentration | 6 months | measured by Dexcom G6 |
| Between group difference in number of low glucose events (LGE) | 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 |
| Between group difference in number of severe hypoglycemic episodes | 6 months | reported by the participant |
| Between group difference in emotional distress due to diabetes measured by the problem areas in diabetes (PAID) questionnaire | 6 months | — |
| Between group difference in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey | 6 months | — |
| Between group difference in treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ) | 6 months | — |
| Between group difference in general quality of life measured by the SF-36 questionnaire | 6 months | — |
| Between group difference in number of patients having allergic reactions to the sensors | 6 months | confirmed by a dermatologist |
| Between group difference in glycemic variability as measured by mean amplitude of glycemic excursions [MAGE] | 6 months | measured by Dexcom G6 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in general quality of life measured by the SF-36 questionnaire | 36 months (extension phase) | within-group change |
| Changes in in fear of hypoglycemia measured by the hypoglycemia fear survey | 36 months (extension phase) | within-group change |
| Changes in hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis, expressed as admissions per patient year) | 36 months (extension phase) | within-group change |
| Changes in in emotional distress due to diabetes measured by the PAID questionnaire | 36 months (extension phase) | within-group change |
| Changes in number of severe hypoglycemic episodes (expressed as number of episodes per patient year) | 36 months (extension phase) | within-group change |
| Number of patients who stop using the Dexcom G6® CGM and the reason to stop | 36 months (extension phase) | within-group change |
| Changes in work absenteeism (expressed as days of work absenteeism per patient year) | 36 months (extension phase) | within-group change |
| Changes in in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey | 36 months (extension phase) | within-group change |
| Changes in treatment satisfaction measured by the DTSQ | 36 months (extension phase) | within-group change |
| 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) | 36 months (extension phase) | within-group change |
| Changes in HbA1c | 36 months (extension phase) | within-group change |
| Number of diabetes contacts which are not preplanned | 6 months | — |
| Resource utilization (cost material, use of extra adhesives) | 6 months | — |
| Number of severe adverse events | 6 months | — |
| Hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis) | 6 months | — |
| Work absenteeism due to diabetes | 6 months | — |
| Number of patients who stop using the Dexcom G6 CGM and the reason to stop | 6 months | — |
| Changes in time in range (70-180 mg/dL) | 36 months (extension phase) | within-group change |
| Changes in time in target (70-140 mg/dL) | 36 months (extension phase) | within-group change |
| Changes in time in hypoglycemia (<70 mg/dL) | 36 months (extension phase) | within-group change |
| Changes in time in clinically important hypoglycemia (<54 mg/dL) | 36 months (extension phase) | within-group change |
| Changes in time in hyperglycemia (>180 mg/dL) | 36 months (extension phase) | within-group change |
| Changes in time in clinically important hyperglycemia (>250 mg/dL) | 36 months (extension phase) | within-group change |
| Changes in time in glycemic variability, defined by coefficient of variation (CV) | 36 months (extension phase) | within-group change |
| Changes in time in glycemic variability, defined by standard deviation (SD) | 36 months (extension phase) | within-group change |
| Changes in time in glycemic variability, defined by mean amplitude of glycemic excursions (MAGE) | 36 months (extension phase) | within-group change |
Countries
Belgium
Outcome results
None listed