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| General |
| Study Status |
Delayed |
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 |
Cross-Sectional 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: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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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 subjects, by assessing the number of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) events with the use of CGM. The sponsor has defined SH as hypoglycemia resulting in a seizure, loss of consciousness, or requiring glucagon by a third party and DKA as requiring an emergency room (ER) visit or hospitalization. The study 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 comprises the intervention period during which subjects will use CGM to manage their diabetes. Subjects will be in the study period for approximately 12 months and will have approximately 3 clinic visits and 10 monthly telephone calls.
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| Study Population |
Adult and pediatric subjects, less than or equal to 2 years of age, with T1D or insulin-requiring T2D, naïve to CGM. Subpopulation enrollment is targeted for 1/3 pediatric and 2/3 adult subjects, with approximately 10% of adult participants greater than or equal to 65 years of age.
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| Sample Size |
1038 subjects at up to 30 investigational sites in the US*
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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 after 6-months of CGM use compared to 6-months of BGM use.
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.
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.
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| Follow-up Visits and Length of Follow-up |
Subjects will be in the study period for approximately 12 months and will have approximately 3 clinic visits and monthly telephone calls (total of 10).
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| Interim or Final Data Summary |
| Interim Results |
Since the last interim progress report was submitted to FDA, five (5) Serious Adverse Events (SAEs) have occurred on four (4) participants during reporting period of October 2, 2021, to October 2, 2022, covered in this interim study status report. All five SAEs are not device related.
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| Actual Number of Patients Enrolled |
985
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| Actual Number of Sites Enrolled |
27
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| Patient Follow-up Rate |
782 subjects have completed the study
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| Final Safety Findings |
Since the last interim progress report was submitted to FDA (P120005/R019); One (1) Serious Adverse Event (SAE) has occurred on one (01) participant during reporting period of October 02, 2022, to October 02, 2023, covered in this interim study status report. The summary of safety data (Serious Adverse Events) related to this study is summarized in Table 15-1 as reported by site Principal Investigators. The reported SAE is not device related.
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| Final Effect Findings |
There is no effectiveness data available at this time for the pediatric population. Since the study is still in the enrollment phase; there is no comparison data available for Clinic Visit Month 12 (Cohort A) or Clinic Visit Month 6 (Cohort B) at this time.
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