N/A
Completed N=10
Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
Source: ClinicalTrials.gov NCT01586065 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Number of High Glucose Correction Doses Administered. — 0; 2; 2; 5 sensor/plasma glucose-based insulin dose
Summary
The purpose of this study is to see if children and adolescents with poorly controlled type 1 diabetes will benefit from using a continuous glucose monitor (CGM), a device that can be used to check blood sugars.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of High Glucose Correction Doses Administered. |
0; 2; 2; 5; 5; 10 | — |
| SECONDARY Pre- and Post-meal (2-3 Hour) Glucose Levels |
157; 163; 174; 183 | — |
Eligibility Criteria
Inclusion Criteria
- 12 to <18 years old
- T1D for at least one year
- Treatment with insulin pump therapy
- A1c ≥9%
- Willingness to comply with study procedures
Exclusion Criteria
- Current diabetic ketoacidosis
- Hypoglycemia unawareness
- Chronic use of medications that affect recognition of hypoglycemia (e.g., beta blockers)
- Chronic use of medications that mimic symptoms of high or low blood sugars (e.g., decongestants)
- Recent or frequent severe hypoglycemia (2 episodes in the last year; 1 episode in the last 6 months)
- Skin rashes or conditions that may affect CGM placement and wear
Data sourced from ClinicalTrials.gov (NCT01586065). 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.