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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P120005 S041/ PAS001 |
| Date Original Protocol Accepted |
12/20/2016
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| Date Current Protocol Accepted |
01/09/2024
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| Study Name |
Dexcom G5 Mobile Cont Glucose Monitoring Sys -PAS
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| Device Name |
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Analytical
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| Study Population |
Child: 2 yrs < 12 yrs,
Adolescent: 13-18 yrs,
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, observational, non-inferiority, adaptive design study intended to evaluate the safety of non-adjunctive CGM use in CGM-naïve adult and pediatric subjects, by assessing the number of hypoglycemic and diabetic ketoacidosis (DKA) events with use of CGM. The sponsor has defined hypoglycemia as (1) severe hypoglycemia resulting in a seizure or loss of consciousness or (2) moderate hypoglycemia defined as the inability to self-treat due to weakness or confusion to take carbohydrates, requiring assistance by a third party. The sponsor defined DKA as requiring an emergency room (ER) visit or hospitalization.
The study has two cohorts:
(1) Cohort A, enrolling adults and pediatric subjects, includes a baseline period of 6 months using a blood glucose meter (BGM) as a comparator. Subjects will perform self-monitored blood glucose (SMBG) testing using their personal BGM. Each subject will serve as their own control defined as the subject’s first 6 months in the study with diabetes management using SMBG. The second six months comprise the intervention period during which subjects will use CGM to manage their diabetes. Cohort A subjects will be in the study period for approximately 12 months and will have approximately 3 clinic visits and 10 monthly telephone calls.
(2) Cohort B, enrolling pediatric subjects, includes only an intervention period of 6 months of study participation, using a CGM. Cohort B participants cannot serve as their own controls because they will not participate in a BGM period. These subjects will be included in all analyses that do not require a control. In order to ensure the safety results are the same for pediatric subjects in Cohort A and those in Cohort B subjects, additional sensitivity analyses will be performed to compare the safety outcomes during the CGM phase for Cohort A and Cohort B to ensure they are similar. Cohort B subjects will be in the study period for approximately 6 months and will have approximately 2 clinic visits and 5 monthly telephone calls.
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| Study Population |
Adult and pediatric subjects, less than or equal to 2 years of age, with type 1 diabetes (T1D) or insulin-requiring type 2 diabetes (T2D), naïve to CGM (either naïve to real-time CGM or may have used professional CGM). Subpopulation enrollment is targeted for 1/3 pediatric (2/3 in Cohort A and 1/3 in Cohort B) and 2/3 adult subjects (all in Cohort A), with approximately 10% of adult participants greater than or equal to 65 years of age.
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| Sample Size |
1110 participants are required to demonstrate non-inferiority of CGM to SMBG. Target enrollment specified up to 1,388 subjects (or more depending on the sample size re-estimation procedure) to allow for an assumed 20% lost to follow-up.
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| Key Study Endpoints |
Primary Endpoint: The primary endpoint for this clinical study is to assess change in the average number of hypoglycemic events per participant after 6-months of CGM use compared to 6-months of BGM use in Cohort A.
Secondary endpoints: The secondary endpoints for this clinical study will be to assess patient reported outcomes, clinical measurements, and CGM metrics after 6-months of CGM use compared with 6-months of baseline data with BGM use in Cohort A. For Cohort B, secondary analyses will assess outcomes after 6-months of CGM use compared with the baseline status collected at the initial visit.
Additional analyses include, but are not limited to the following:
Clinical Measurements
1. A1C change, overall and across the A1C range
2. Change in percentage of participants with at least one (1) hypoglycemia event
3. Change in the percentage of participants with at least one (1) diabetic ketoacidosis event
4. Percentage of participants with increased and decreased number of hypoglycemia events
5. Change in the number & proportion of hypoglycemia events stratified by day versus night
Patient Reported Outcomes
1. Glucose Monitoring Satisfaction Survey (GMSS)
2. CGM Satisfaction
3. Diabetes Distress Scale (DDS)
4. Hypoglycemia Fear Survey-Worry subscale (HFS-W)
5. Hypoglycemia Confidence
CGM Metrics-comparing Month 7 (after CGM initiated) with Month 12:
1. Average of CGM Glucose
2. Standard Deviation (SD) of CGM glucose
3. Percentage of CGM glucose within range: 70-180 mg/dL
4. Percent Time-in-Hypoglycemia (<70 mg/dL)
5. Percentage of CGM glucose in Hypoglycemia: (<55 mg/dL)
6. Percent Time-in-Hyperglycemia (>250 mg/dL)
7. Percentage of CGM glucose in Hyperglycemia (>300 mg/dL)
Other Metrics
1. CGM adherence: frequency of CGM use at month 12 compared to month 7 of CGM use
2. Change in SMBG frequency after initiation of CGM compared to baseline period, defined aa time point when BGM or CGM is established (months 3-6 for BGM and months 9-12 for CGM)
3. Change in the numbers & proportions of hypoglycemic events stratified by sensor location (used in approved wear locations or off-label)
4. A subpopulation analyses will be conducted at the end of the study, including but not limited to: Type 1 diabetes, Type 2 diabetes, adult, pediatric, and elderly.
In addition, the safety outcomes for the additional outcomes listed above will be repeated to compare the outcomes for pediatric subjects in Cohort A and those in Cohort B.
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| Follow-up Visits and Length of Follow-up |
Follow-up Visits and Length of Follow-up Subjects in Cohort A will be in the study period for approximately 12 months and will have approximately 3 clinic visits and monthly telephone calls (total of 10). Subjects in Cohort B will be in the study period for approximately 6 months and will have approximately 2 clinic visits and monthly telephone calls (total of 5).
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