N/A
Completed N=68
Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes
Source: ClinicalTrials.gov NCT01083433 ↗Enrolled (actual)
68
Serious AEs
10.3%
Results posted
Jan 2022
Primary outcomePrimary: Glycemic Control — 10.8; 9.43; 9.4; 11.0 percent HbA1c
Summary
The purpose of this research study is to find out ways to help pre-teens and teens and their families to improve diabetes control and to help with the burden of diabetes management. Specifically, the study aims to find out if coming to diabetes clinic more frequently and for a longer period of time helps adolescents with diabetes, and if adolescents who wear a continuous glucose monitor (CGM) for 3-5 days a month will have better diabetes control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Control |
10.8; 9.43; 9.4; 11.0; 9.93; 10.0 | — |
| SECONDARY Insulin Dose Changes |
1.02; 1.03; 1.10; 0.98; 1.09; 1.0 | — |
| SECONDARY Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL) |
3.3; 3.7; 3.8; 2.9; 4.4; 4.0 | — |
| SECONDARY Adherence to Prescribed Diabetes Regimen |
51; 58.0; 54.9; 47.3; 50.2; 50.9 | — |
| SECONDARY Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor |
6.3; 5.5; 6.1; 6.6 | — |
| SECONDARY Diabetes Knowledge |
33; 33; 31; 33; 33; 33 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetes mellitus of at least 12 months duration, followed by Rainbow Babies and Children's Pediatric Endocrinology and Diabetes Division
- Most recent HbA1c >= 8.5%
- Patients must be willing to check their blood sugar at least 4 times daily while wearing the CGM
- Patients and families must be willing to come to diabetes clinic once a month for 4 months
Exclusion Criteria
- Inability to understand and/or speak the English language
- Pregnancy
- Psychological counseling with Dr. Rebecca Hazen regarding diabetes adherence prior to the study
Data sourced from ClinicalTrials.gov (NCT01083433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.