Clinical Efficacy of a Diabetes Educational Program to Improve Flash Adherence in Type 1 Diabetes Patients

Study Overview
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Brief Summary
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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
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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).

Official Title
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Clinical Efficacy of a Diabetes Educational Program to Improve Intermittently Continuous Glucose Monitoring (Flash) Adherence in Type 1 Diabetes Patients

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: Diabetes educational program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 30 minutes diabetes educational program: 10-minute talk about Flash measurements and importance of diabetes control. 10-minute practic exercises with Flash values and tendencies. 10-minute talk about recomendations for increasing daily Flash scanning.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Flash adherence<br>Adult (>18 yrs old) type 1 diabetes patients with 4 or less daily Flash scans | Other: Diabetes educational program<br>* 30-minute long diabetes educational program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Flash 1 | Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans per day) | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in range | Time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) of interstitial glucose | 14 days | 
| Adherence to Flash 2 | Time of use of intermittently scanned continuous glucose monitoring (% possible time of use) | 14 days | 
| Time below range 1 (TBR1) | Time bellow range <3.9 mmol/L (<70 mg/dL) of the interstitial glucose | 14 days | 
| Time below range 2 (TBR2) | Time bellow range <3 mmol/L (<54 mg/dL) of the interstitial glucose | 14 days | 
| Time above range 1 (TAR1) | Time above range >10 mmol/L(>180 mg/dL) of the interstitial glucose | 14 days | 
| Time above range 2 (TAR2) | Time above range >13.9 mmol/L (>250 mg/dL) of the interstitial glucose | 14 days | 
| Coefficient of variation percentage (CV) | Coefficient of variation percentage of interstitial glucose | 14 days | 
| Glucose management index | Glucose management index of interstitial glucose | 14 days | 
| Time in hypoglycemia | Daily time in hypoglycemia (<3.9 mmol/L, <70 mg/dL) of interstitical glucose | 14 days | 
| Hypoglycemia frequency | Number of daily hypoglycemic events (<3.9 mmol/L, <70 mg/dL) of interstitical glucose | 14 days | 
| Percentage of patients attaining the the International Consensus on Time in Range (ICTR) | Percentage of patients (from total) attaining TIR>70%, TBR1<4%, TBR2<1%, TAR1<25%, TAR2<5% and CV <36% | 14 days |