Continuous Monitoring and Control of Hypoglycemia
- Conditions
- Diabetes
- Interventions
- Device: Continuous Glucose Monitoring (CGM)
- Registration Number
- NCT03340831
- Lead Sponsor
- DexCom, Inc.
- Brief Summary
Evaluate safety of non-adjunctive CGM use in CGM naive participants.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1388
- Naïve to real-time CGM
- Type 1 or insulin-requiring Type 2 diabetes
- ≥ 2 years old
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CGM/BGM Group Continuous Glucose Monitoring (CGM) 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).
- Primary Outcome Measures
Name Time Method Change in hypoglycemic events 6 months Change in average number of hypoglycemic events per patient between CGM use compared to BGM use
- Secondary Outcome Measures
Name Time Method Change in A1C 6 months Percent change in A1C lab between CGM use period compared to BGM use period.
Change in incidence of hypoglycemic events 6 months Percent change of participants with at least one event between CGM use period compared to BGM use period.
Change in Hypoglycemia Confidence PRO scores 6 months Percent change in mean scores for the Hypoglycemia Confidence Scale between CGM use period compared to BGM use period.
Change in GMSS PRO scores 6 months 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.
Change in Diabetes Distress Scale (DDS) PRO scores 6 months Percent change in mean scores for the DDS between CGM use period compared to BGM use period.
Change in Hypoglycemia Fear PRO scores 6 months Percent change in mean scores for the Hypoglycemia Fear Survey between CGM use period compared to BGM use period.
Trial Locations
- Locations (25)
Scripps Whittier Diabetes Institute
🇺🇸La Jolla, California, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Diabetes & Endocrinology Consultants, PC
🇺🇸Morehead City, North Carolina, United States
Diabetes and Endocrine Associates
🇺🇸La Mesa, California, United States
Mills-Peninsula Medical Center
🇺🇸San Mateo, California, United States
Rocky Mountain Diabetes Center
🇺🇸Idaho Falls, Idaho, United States
Mountain Diabetes and Endocrine Center
🇺🇸Asheville, North Carolina, United States
Sansum Diabetes Research Institute
🇺🇸Santa Barbara, California, United States
Intervent Clinical Research Center
🇺🇸Pembroke Pines, Florida, United States
Atlanta Diabetes
🇺🇸Atlanta, Georgia, United States
Northshore University Health System
🇺🇸Skokie, Illinois, United States
International Diabetes Research Center
🇺🇸Minneapolis, Minnesota, United States
Research Institute of Dallas
🇺🇸Dallas, Texas, United States
Advanced Research Associates
🇺🇸Ogden, Utah, United States
Cotton O'Neil Clinical Research
🇺🇸Topeka, Kansas, United States
Vanderbilt Eskind Diabetes Clinic
🇺🇸Nashville, Tennessee, United States
University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology
🇺🇸Oklahoma City, Oklahoma, United States
University of South Florida Clinical Research Center
🇺🇸Tampa, Florida, United States
Methodist Physicians Clinic - Diabetes and Endocrine Specialists
🇺🇸Omaha, Nebraska, United States
Amarillo Medical Specialists, LLP
🇺🇸Amarillo, Texas, United States
Centre of Excellence in Diabetes and Endocrinology
🇺🇸Sacramento, California, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
University of Florida Pediatric Endocrinology
🇺🇸Gainesville, Florida, United States
Texas Diabetes and Endocrine
🇺🇸Austin, Texas, United States
Iowa Diabetes & Endocrinology Research Center
🇺🇸Des Moines, Iowa, United States