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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Diabetes educational program

• Registration Number: NCT05570162
• Lead Sponsor: Castilla-La Mancha Health Service

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).

Study Timeline

• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-06
• Study Start: 2022-11-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Flash adherence	Diabetes educational program	Adult (\>18 yrs old) type 1 diabetes patients with 4 or less daily Flash scans

Primary Outcome Measures

Name	Time	Method
Adherence to Flash 1	14 days	Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans per day)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ciudad Real General University Hospital; 🇪🇸 Ciudad Real, Spain