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

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diabetes educational program
Sponsored by
Castilla-La Mancha Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ciudad Real General University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low Flash adherence

Arm Description

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

Outcomes

Primary Outcome Measures

Adherence to Flash 1
Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans per day)

Secondary Outcome Measures

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

Full Information

First Posted
October 4, 2022
Last Updated
July 4, 2023
Sponsor
Castilla-La Mancha Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT05570162
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Castilla-La Mancha Health Service

4. Oversight

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
Data Monitoring Committee
No

5. 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Flash adherence
Arm Type
Experimental
Arm Description
Adult (>18 yrs old) type 1 diabetes patients with 4 or less daily Flash scans
Intervention Type
Other
Intervention Name(s)
Diabetes educational program
Intervention Description
30-minute long diabetes educational program
Primary Outcome Measure Information:
Title
Adherence to Flash 1
Description
Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans per day)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Time in range
Description
Time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) of interstitial glucose
Time Frame
14 days
Title
Adherence to Flash 2
Description
Time of use of intermittently scanned continuous glucose monitoring (% possible time of use)
Time Frame
14 days
Title
Time below range 1 (TBR1)
Description
Time bellow range <3.9 mmol/L (<70 mg/dL) of the interstitial glucose
Time Frame
14 days
Title
Time below range 2 (TBR2)
Description
Time bellow range <3 mmol/L (<54 mg/dL) of the interstitial glucose
Time Frame
14 days
Title
Time above range 1 (TAR1)
Description
Time above range >10 mmol/L(>180 mg/dL) of the interstitial glucose
Time Frame
14 days
Title
Time above range 2 (TAR2)
Description
Time above range >13.9 mmol/L (>250 mg/dL) of the interstitial glucose
Time Frame
14 days
Title
Coefficient of variation percentage (CV)
Description
Coefficient of variation percentage of interstitial glucose
Time Frame
14 days
Title
Glucose management index
Description
Glucose management index of interstitial glucose
Time Frame
14 days
Title
Time in hypoglycemia
Description
Daily time in hypoglycemia (<3.9 mmol/L, <70 mg/dL) of interstitical glucose
Time Frame
14 days
Title
Hypoglycemia frequency
Description
Number of daily hypoglycemic events (<3.9 mmol/L, <70 mg/dL) of interstitical glucose
Time Frame
14 days
Title
Percentage of patients attaining the the International Consensus on Time in Range (ICTR)
Description
Percentage of patients (from total) attaining TIR>70%, TBR1<4%, TBR2<1%, TAR1<25%, TAR2<5% and CV <36%
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesus Moreno, PhD
Phone
926278000
Email
jmorenof@sescam.jccm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus Moreno-Fernandez, PhD
Organizational Affiliation
Ciudad Real General University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ciudad Real General University Hospital
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Moreno-Fernandez, PhD
Phone
926278000
Email
jmorenof@sescam.jccm.es

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
28970034
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. Erratum In: Lancet Diabetes Endocrinol. 2018 Feb;6(2):e2.
Results Reference
result
PubMed Identifier
30844467
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.
Results Reference
result
PubMed Identifier
27634581
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.
Results Reference
result
PubMed Identifier
29278709
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.
Results Reference
result
PubMed Identifier
32198165
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.
Results Reference
result

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

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