Clinical trial NCT05570162: Clinical Efficacy of a Diabetes Educational Program to Improve Flash Adherence in Type 1 Diabetes Patients
Official title: Clinical Efficacy of a Diabetes Educational Program to Improve Intermittently Continuous Glucose Monitoring (Flash) Adherence in Type 1 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Castilla-La Mancha Health Service
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Adherence to Flash 1
timeFrame: 14 days
Secondary outcomes:
measure: Time in range
timeFrame: 14 days
measure: Adherence to Flash 2
timeFrame: 14 days
measure: Time below range 1 (TBR1)
timeFrame: 14 days
measure: Time below range 2 (TBR2)
timeFrame: 14 days
measure: Time above range 1 (TAR1)
timeFrame: 14 days
measure: Time above range 2 (TAR2)
timeFrame: 14 days
measure: Coefficient of variation percentage (CV)
timeFrame: 14 days
measure: Glucose management index
timeFrame: 14 days
measure: Time in hypoglycemia
timeFrame: 14 days
measure: Hypoglycemia frequency
timeFrame: 14 days
measure: Percentage of patients attaining the the International Consensus on Time in Range (ICTR)
timeFrame: 14 days
Other outcomes:
Locations:
city: Ciudad Real
country: Spain
facility: Ciudad Real General University Hospital
Study officials:
affiliation: Ciudad Real General University Hospital
name: Jesus Moreno-Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. Epub 2017 Sep 29.
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. Diabetes Res Clin Pract. 2019 Apr;150:111-121. doi: 10.1016/j.diabres.2019.03.003. Epub 2019 Mar 4.
citation: 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/S0140-6736(16)31535-5. Epub 2016 Sep 12.
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. doi: 10.1016/j.diabres.2017.12.015. Epub 2017 Dec 24.
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.