N/A
Completed N=239
A French Study to Evaluate the Usefulness of an Implantable Continuous Glucose Monitoring (CGM) Sensor to Improve Glycemic Control in Participants With Diabetes Mellitus
Source: ClinicalTrials.gov NCT03445065 ↗Enrolled (actual)
239
Serious AEs
5.2%
Results posted
Sep 2021
Primary outcomePrimary: Cohort 1: HbA1c (%) Levels at Day 180 — 8.6; 8.8 HbA1c (%) — p=0.341
Summary
This study will be conducted in France and will evaluate the usefulness of using a long-term subcutaneously inserted continuous glucose monitoring (CGM) sensor (the Eversense XL CGM System) to improve glycemic control in patients with either Type 1 or Type 2 diabetes mellitus under insulin therapy. Participants will be enrolled into one of two cohorts (Cohorts 1 and 2). Cohort 1 will be focused on participants with Type 1 or Type 2 diabetes with hemoglobin A1C (HbA1c) >8%. Cohort 2 will be focused on participants with Type 1 diabetes spending more than 1.5 hours per day with mean glucose <70 mg/dL, including excursions below 54 mg/dL, for at least 28 days. Within each cohort, participants will be randomized in a 2:1 ratio to one of two groups: the Enabled and Control groups, respectively. The Enabled group will be trained to use the CGM system, whereas the Control group will continue with their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: HbA1c (%) Levels at Day 180 |
8.6; 8.8 | 0.341 |
| PRIMARY Cohort 2: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) From Day 90 to Day 120 |
4.0; 5.7 | 0.03892 sig |
| SECONDARY Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion |
1; 1; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Overall Number of Participants With at Least One Adverse Event |
46; 19; 25; 9; 2; 7 | — |
| SECONDARY Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 90 to Day 120 |
47.4; 42.1; 59.8; 55.0 | 0.056 |
| SECONDARY Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 90 to Day 120 |
18.5; 24.0; 8.5; 9.5 | 0.015 sig |
| SECONDARY Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 90 to Day 120 |
50.0; 55.2; 30.7; 34.0 | 0.080 |
| SECONDARY Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 90 to Day 120 |
2.6; 2.8; 9.5; 11.3 | 0.671 |
| SECONDARY Cohort 1: Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 90 to Day 120 |
1.1; 1.2 | 0.693 |
| SECONDARY Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 150 to Day 180 |
47.0; 48.0; 60.7; 61.1 | 0.753 |
| SECONDARY Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 150 to Day 180 |
18.5; 19.4; 8.7; 6.3 | 0.653 |
| SECONDARY Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 150 to Day 180 |
50.8; 49.5; 30.9; 27.8 | 0.685 |
| SECONDARY Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 150 to Day 180 |
2.1; 2.4; 8.4; 11.7 | 0.549 |
| SECONDARY Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 150 to Day 180 |
1.1; 1.0; 3.4; 6.0 | 0.859 |
| SECONDARY Cohort 2, Enabled Arm: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) During the Day 90-120 Period Compared With the Day 150-180 Period for the Enabled Group |
4.232; 3.430 | 0.045 sig |
| SECONDARY Cohort 2, Control Arm: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) During the Control Period (Days 90-120) Compared With the Enabled Period (Days 150-180) for Participants Who Switched to Use the CGM System |
5.792; 6.263 | 0.763 |
| SECONDARY Glucose Variability From Day 90 to Day 120, as Estimated With a Coefficient of Variation |
29.3; 28.0; 35.8; 36.3 | 0.140 |
| SECONDARY Glucose Variability From Day 150 to Day 180, as Estimated by a Coefficient of Variation |
26.0; 25.0; 34.4; 35.1 | 0.339 |
| SECONDARY HbA1c (%) Levels at Day 120 |
8.6; 8.7; 7.2; 7.3 | 0.558 |
| SECONDARY Cohort 2: HbA1c (%) Levels at Day 180 |
7.2; 7.2 | 0.616 |
| SECONDARY Number of Participants With the First Sensor Operating at Day 150 and Day 180 |
73; 27; 40; 19; 38; 10 | — |
| SECONDARY Mean Lifespan of the First Sensor |
159.2; 139.8; 147.3; 156.9 | — |
| SECONDARY Median Number of Sensors Used by Each Participant During the Study |
1.0; 1.0; 1.0; 1.0 | — |
| SECONDARY Number of Participants With the First Transmitter Operating at Day 150 and Day 180 |
1; 23; 0; 3; 1; 13 | — |
| SECONDARY Mean Lifespan of the First Transmitter |
34.6; 140.6; 33.8; 114.6 | — |
| SECONDARY Median Number of Transmitters Used by Each Participant During the Study |
2.0; 1.0; 2.0; 2.0 | — |
| SECONDARY Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180 |
67; 43; 75; 44; 61; 38 | — |
| SECONDARY Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study |
97; 52; 62; 28; 97; 52 | — |
| SECONDARY Diabetes Treatment Satisfaction Questionnaire - Original Status (DTSQs) Treatment Satisfaction Score at Baseline, Day 60, and Day 180 |
27.0; 24.4; 26.4; 26.8; 28.3; 24.3 | — |
| SECONDARY Change From Baseline in the DTSQs Treatment Satisfaction Score at Day 60 and Day 180 |
1.3; 0.2; 1.7; -1.8; -0.1; -0.1 | — |
| SECONDARY Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc) Treatment Satisfaction Score at Day 180 |
8.6; 7.1; 8.6; 5.3 | — |
| SECONDARY Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Baseline and Day 180 |
-2.9; -3.0; -2.7; -1.9; -2.7; -3.2 | — |
| SECONDARY Change From Baseline in the Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Day 180 |
0.1; 0.0; 0.1; 0.4 | — |
| SECONDARY The Continuous Glucose Monitoring Satisfaction (CGM-SAT) Questionnaire Overall Score at Day 60 and Day 180 |
2.9; 3.0; 2.8; 2.8 | — |
| SECONDARY Change From Day 60 in the CGM-SAT Questionnaire Overall Score at Day 180 |
-0.1; -0.1 | — |
| SECONDARY Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Baseline, Day 60, and Day 180 |
2.4; 3.1; 2.8; 2.3; 2.1; 3.0 | — |
| SECONDARY Change From Baseline in the Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Day 60 and Day 180 |
-0.2; 0.0; -0.3; 0.6; -0.2; -0.6 | — |
| SECONDARY Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Baseline, Day 60, and Day 180 |
21.4; 21.6; 26.6; 19.0; 17.4; 21.3 | — |
| SECONDARY Change From Baseline in the Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Day 60 and Day 180 |
-4.0; -0.3; -1.4; -1.4; -5.2; 1.4 | — |
| SECONDARY Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180 |
0.0; 0.1; 0.1; -0.4; -1.1; 0.6 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female participants at least 18 years of age
- Clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and an HbA1c > 8% (Cohort 1)
- Clinically confirmed diagnosis of Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending more than more than 1.5 hour with sensor glucose <70 mg/dl per day including excursions below 54 mg/dl as a mean for at least 28 days (Cohort 2)
- Participant is willing to comply with protocol
Exclusion Criteria
- Female participants of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study
- A condition preventing or complicating the placement, operation or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition
- History of hepatitis B, hepatitis C, or HIV
- Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin < 2000 mg per day); antibiotics for chronic infection (e.g. osteomyelitis, endocarditis)
- A condition requiring or likely to require magnetic resonance imaging (MRI)
- Known topical or local anesthetic allergy
- Known allergy to glucocorticoids or using systemic glucocorticoids (excluding topical, optical or nasal but including inhaled)
- Any condition that in the investigator's opinion would make the participant unable to complete the study or would make it not in the participant's best interest to participate in the study. Conditions include, but are not limited to, psychiatric conditions, known current or recent alcohol abuse or drug abuse by participant history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion
- Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period
- Legal incompetence or limited legal competence
- Dependency on sponsor or Investigator (e.g. co-worker or family member)
- The presence of any other active implanted device
Data sourced from ClinicalTrials.gov (NCT03445065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.