Clinical Efficacy of a Diabetes Educational Program to Improve Intermittently Continuous Glucose Monitoring (Flash) Adherence in Type 1 Diabetes Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes
- Sponsor
- Castilla-La Mancha Health Service
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Adherence to Flash 1
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Prospective observational study to analyse the clinical effectiveness of a diabetes educational program to improve intermittently continuous glucose monitoring (iCGM) adherence in adult type 1 diabetes (T1D) patients
Detailed Description
Cross-sectional prospective analysis of clinical efectiveness of a diabetes educational program to improve intermittently continuous glucose monitoring (iCGM) adherence in adult type 1 diabetes (T1D) patients. Glycometric data obtained through deidentified downloads from isCGM´s webpage. Primary outcome was time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) change after the heatwave. Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant. The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee (C-558).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 1 diabetes
- •Flash user for at least 6 months.
- •Treatment with multiple daily insulin injections (MDI).
- •Daily scan Flash frequency 4 or less
Exclusion Criteria
- •Other types of diabetes
- •Other types of diabetes treatment different from MDI (pe insulin pump)
Outcomes
Primary Outcomes
Adherence to Flash 1
Time Frame: 14 days
Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans per day)
Secondary Outcomes
- Time above range 2 (TAR2)(14 days)
- Glucose management index(14 days)
- Percentage of patients attaining the the International Consensus on Time in Range (ICTR)(14 days)
- Time above range 1 (TAR1)(14 days)
- Time in range(14 days)
- Time below range 2 (TBR2)(14 days)
- Time in hypoglycemia(14 days)
- Coefficient of variation percentage (CV)(14 days)
- Adherence to Flash 2(14 days)
- Time below range 1 (TBR1)(14 days)
- Hypoglycemia frequency(14 days)