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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05570162
• Other study ID #: C-558
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2023
• Source: Castilla-La Mancha Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 1, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Diabetes educational program
30-minute long diabetes educational program

Locations

Country	Name	City	State
Spain	Ciudad Real General University Hospital	Ciudad Real

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-La Mancha Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S014 — View Citation

Chatterjee S, Davies MJ, Heller S, Speight J, Snoek FJ, Khunti K. Diabetes structured self-management education programmes: a narrative review and current innovations. Lancet Diabetes Endocrinol. 2018 Feb;6(2):130-142. doi: 10.1016/S2213-8587(17)30239-5. — View Citation

Dunn TC, Xu Y, Hayter G, Ajjan RA. Real-world flash glucose monitoring patterns and associations between self-monitoring frequency and glycaemic measures: A European analysis of over 60 million glucose tests. Diabetes Res Clin Pract. 2018 Mar;137:37-46. d — View Citation

Gomez-Peralta F, Dunn T, Landuyt K, Xu Y, Merino-Torres JF. Flash glucose monitoring reduces glycemic variability and hypoglycemia: real-world data from Spain. BMJ Open Diabetes Res Care. 2020 Mar;8(1):e001052. doi: 10.1136/bmjdrc-2019-001052. — View Citation

Hermanns N, Ehrmann D, Schipfer M, Kroger J, Haak T, Kulzer B. The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial. Di — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Flash 1	Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans per day)	14 days
Secondary	Time in range	Time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) of interstitial glucose	14 days
Secondary	Adherence to Flash 2	Time of use of intermittently scanned continuous glucose monitoring (% possible time of use)	14 days
Secondary	Time below range 1 (TBR1)	Time bellow range <3.9 mmol/L (<70 mg/dL) of the interstitial glucose	14 days
Secondary	Time below range 2 (TBR2)	Time bellow range <3 mmol/L (<54 mg/dL) of the interstitial glucose	14 days
Secondary	Time above range 1 (TAR1)	Time above range >10 mmol/L(>180 mg/dL) of the interstitial glucose	14 days
Secondary	Time above range 2 (TAR2)	Time above range >13.9 mmol/L (>250 mg/dL) of the interstitial glucose	14 days
Secondary	Coefficient of variation percentage (CV)	Coefficient of variation percentage of interstitial glucose	14 days
Secondary	Glucose management index	Glucose management index of interstitial glucose	14 days
Secondary	Time in hypoglycemia	Daily time in hypoglycemia (<3.9 mmol/L, <70 mg/dL) of interstitical glucose	14 days
Secondary	Hypoglycemia frequency	Number of daily hypoglycemic events (<3.9 mmol/L, <70 mg/dL) of interstitical glucose	14 days
Secondary	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