Continuous Monitoring and Control of Hypoglycemia

Study Overview
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Brief Summary
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Evaluate safety of non-adjunctive CGM use in CGM naive participants.

Detailed Description
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The study comprises recruitment and consenting of pediatric and adult participants. At entry, the following information will be collected: demographics, labs, clinical and diabetes history information (history of mild/severe hypoglycemia or DKA events in the past 6 months and SMBG testing frequency). There are 3 clinic visits: Study Entry, Month 6 and Month 12 . Monthly phone contacts will be made to assess for any mild/severe hypoglycemic or DKA events and any details surrounding an event. Clinic visits at Months 6 and 12 will capture frequency of SMBG testing, A1C level and PRO information. CGM data will be obtained during the study to assess for CGM adherence.

Official Title
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Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management

Conditions
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Diabetes

Intervention / Treatment
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* Device: Continuous Glucose Monitoring (CGM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Naïve to real-time CGM Type 1 or insulin-requiring Type 2 diabetes ≥ 2 years old Exclusion Criteria: Use of RT-CGM, within the past 12 months Pregnancy Concomitant disease or condition that may compromise patient safety including and not limited to severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits, or ongoing treatment for a significant malignancy. Known (or suspected) significant allergy to medical grade adhesives Dialysis

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CGM/BGM Group<br>single-group, whereby participant is their own control. Use of a Blood Glucose Meter (BGM) for 6 months is compared to use of the G5 and G6 CGM System for 6 months, with collection of major diabetes related events (mild/severe hypoglycemia and DKA). | Device: Continuous Glucose Monitoring (CGM)<br>* Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hypoglycemic events | Change in average number of hypoglycemic events per patient between CGM use compared to BGM use | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1C | Percent change in A1C lab between CGM use period compared to BGM use period. | 6 months | 
| Change in incidence of hypoglycemic events | Percent change of participants with at least one event between CGM use period compared to BGM use period. | 6 months | 
| Change in GMSS PRO scores | Percent change in mean scores for the Glucose monitoring satisfaction survey (GMSS) [Emotional and Trust subscales] between CGM use period compared to BGM use period. | 6 months | 
| Change in Diabetes Distress Scale (DDS) PRO scores | Percent change in mean scores for the DDS between CGM use period compared to BGM use period. | 6 months | 
| Change in Hypoglycemia Fear PRO scores | Percent change in mean scores for the Hypoglycemia Fear Survey between CGM use period compared to BGM use period. | 6 months | 
| Change in Hypoglycemia Confidence PRO scores | Percent change in mean scores for the Hypoglycemia Confidence Scale between CGM use period compared to BGM use period. | 6 months |