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

NCT ID: NCT05570162

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-10-01

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).

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low Flash adherence

Adult (\>18 yrs old) type 1 diabetes patients with 4 or less daily Flash scans

Group Type EXPERIMENTAL

Diabetes educational program

Intervention Type OTHER

30-minute long diabetes educational program

Interventions

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Diabetes educational program

30-minute long diabetes educational program

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Castilla-La Mancha Health Service

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jesus Moreno-Fernandez, PhD

Role: PRINCIPAL_INVESTIGATOR

Ciudad Real General University Hospital

Locations

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Ciudad Real General University Hospital

Ciudad Real, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 28970034 (View on PubMed)

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.

Reference Type RESULT
PMID: 30844467 (View on PubMed)

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.

Reference Type RESULT
PMID: 27634581 (View on PubMed)

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.

Reference Type RESULT
PMID: 29278709 (View on PubMed)

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.

Reference Type RESULT
PMID: 32198165 (View on PubMed)

Other Identifiers

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C-558

Identifier Type: -

Identifier Source: org_study_id

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