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Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control (OPTIM@TE)

Primary Purpose

Diabetes Mellitus, Type I

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Online education programme
Standard education programme
Sponsored by
Hospital Mutua de Terrassa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type I focused on measuring Diabetes Mellitus, Type I, education programme, online

Eligibility Criteria

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

Inclusion Criteria: HbA1c ≥7,5% More than 3 years of diagnosis Ability to follow online sessions Having a device to follow up the education programme Exclusion Criteria: Pregnants People on corticosteroid treatment People with severe disease People with continuous subcutaneous insulin infusion (CSII)

Sites / Locations

  • Hospital Mutua de TerrassaRecruiting
  • Hospital Universitari Mútua de TerrassaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care

Online education programme

Arm Description

Group in face-to-face session

Group in online sessions

Outcomes

Primary Outcome Measures

HbA1c
glycosylated hemoglobin

Secondary Outcome Measures

Time in Range (TIR)
Time spent between 70-180 mg/dl measured by glucose sensor
Knowledge related to diabetes management
Diabetes Knowledge Questionnaire (DKQ2)- 15 questions with 4 options, high score indicates maximum level of knowledge
Awareness of hypoglycemia
Clarke Test- 8 questions, ≥ 4 answers with R= reduced awareness

Full Information

First Posted
March 29, 2022
Last Updated
January 24, 2023
Sponsor
Hospital Mutua de Terrassa
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1. Study Identification

Unique Protocol Identification Number
NCT05708820
Brief Title
Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control
Acronym
OPTIM@TE
Official Title
Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Mutua de Terrassa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate the effectiveness of an online intervention for people with type 1 diabetes who present not optimal control of the disease.
Detailed Description
Study area: adults with type 1 diabetes, HbA1c >7.5%, >3 years diagnosed. Methods: randomized clinical trial. It will include 60 participants . The improvement of Glycated Haemoglobin in both groups before and after intervention will be compared; adherence to the treatment, quality of life, time in the glycaemic range, perception of hypoglycaemia and knowledge about diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type I
Keywords
Diabetes Mellitus, Type I, education programme, online

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Group in face-to-face session
Arm Title
Online education programme
Arm Type
Experimental
Arm Description
Group in online sessions
Intervention Type
Behavioral
Intervention Name(s)
Online education programme
Intervention Description
Online group will follow the education programme through videos that they can view at any time and a live session to answer questions.
Intervention Type
Behavioral
Intervention Name(s)
Standard education programme
Intervention Description
Face-to-face educacion programme in a group session
Primary Outcome Measure Information:
Title
HbA1c
Description
glycosylated hemoglobin
Time Frame
Change from Baseline at 12 months
Secondary Outcome Measure Information:
Title
Time in Range (TIR)
Description
Time spent between 70-180 mg/dl measured by glucose sensor
Time Frame
Change from Baseline at 12 months
Title
Knowledge related to diabetes management
Description
Diabetes Knowledge Questionnaire (DKQ2)- 15 questions with 4 options, high score indicates maximum level of knowledge
Time Frame
Change from Baseline at 12 months
Title
Awareness of hypoglycemia
Description
Clarke Test- 8 questions, ≥ 4 answers with R= reduced awareness
Time Frame
Change from Baseline at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HbA1c ≥7,5% More than 3 years of diagnosis Ability to follow online sessions Having a device to follow up the education programme Exclusion Criteria: Pregnants People on corticosteroid treatment People with severe disease People with continuous subcutaneous insulin infusion (CSII)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Núria Alonso-Carril, RN
Phone
+34 937365050
Ext
11330
Email
nuriaalonso@mutuaterrassa.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Núria Alonso, RN
Organizational Affiliation
Hospital Universitari Mútua Terrassa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Endocrinology Unit
First Name & Middle Initial & Last Name & Degree
Núria Alonso, RN
Facility Name
Hospital Universitari Mútua de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Núria Alonso-Carril, RN
First Name & Middle Initial & Last Name & Degree
Núria Alonso

12. IPD Sharing Statement

Plan to Share IPD
No

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Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control

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