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

• Sponsor: Castilla-La Mancha Health Service (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05570162
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 2
• Patients Per Site Per Month: 20.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Other: Diabetes educational program	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 41 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Clinical Efficacy of a Diabetes Educational Program to Improve Intermittently Continuous Glucose Monitoring (Flash) Adherence in Type 1 Diabetes Patients
• Actual Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adherence to Flash 1 [14 days]

   Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans per day)

Secondary Outcome Measures

1. Time in range [14 days]

   Time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) of interstitial glucose

2. Adherence to Flash 2 [14 days]

   Time of use of intermittently scanned continuous glucose monitoring (% possible time of use)

3. Time below range 1 (TBR1) [14 days]

   Time bellow range <3.9 mmol/L (<70 mg/dL) of the interstitial glucose

4. Time below range 2 (TBR2) [14 days]

   Time bellow range <3 mmol/L (<54 mg/dL) of the interstitial glucose

5. Time above range 1 (TAR1) [14 days]

   Time above range >10 mmol/L(>180 mg/dL) of the interstitial glucose

6. Time above range 2 (TAR2) [14 days]

   Time above range >13.9 mmol/L (>250 mg/dL) of the interstitial glucose

7. Coefficient of variation percentage (CV) [14 days]

   Coefficient of variation percentage of interstitial glucose

8. Glucose management index [14 days]

   Glucose management index of interstitial glucose

9. Time in hypoglycemia [14 days]

   Daily time in hypoglycemia (<3.9 mmol/L, <70 mg/dL) of interstitical glucose

10. Hypoglycemia frequency [14 days]

    Number of daily hypoglycemic events (<3.9 mmol/L, <70 mg/dL) of interstitical glucose

11. 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%

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ciudad Real General University Hospital	Ciudad Real		Spain	13005

Sponsors and Collaborators

• Castilla-La Mancha Health Service

Investigators

• Principal Investigator: Jesus Moreno-Fernandez, PhD, Ciudad Real General University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Castilla-La Mancha Health Service
• ClinicalTrials.gov Identifier: NCT05570162
• Other Study ID Numbers: C-558
• First Posted: Oct 6, 2022
• Last Update Posted: Nov 30, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Nov 30, 2022