Diabetes
Conditions
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.
Interventions
DEVICEContinuous Glucose Monitoring (CGM)
Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM)
Sponsors
DexCom, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hypoglycemic events | 6 months | Change in average number of hypoglycemic events per patient between CGM use compared to BGM use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 A1C | 6 months | Percent change in A1C lab 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. |
| 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 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. |
Countries
United States
Contacts
Primary ContactStayce Beck, PhD, MPH
Backup ContactNelly Njeru
Outcome results
None listed