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

November 10, 2023 updated by: Castilla-La Mancha Health Service

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Ciudad Real, Spain, 13005
        • Ciudad Real General University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Flash 1
Time Frame: 14 days
Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans per day)
14 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castilla-La Mancha Health Service

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Under other researchers request.

IPD Sharing Time Frame

Data will become available after 1 month of the request and for a 3-month period.

IPD Sharing Access Criteria

After request study from IP and ethic comittee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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