Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control
OPTIM@TE
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2022
CompletedStudy Start
First participant enrolled
December 14, 2022
CompletedFirst Posted
Study publicly available on registry
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedFebruary 1, 2023
January 1, 2023
8 months
March 29, 2022
January 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c
glycosylated hemoglobin
Change from Baseline at 12 months
Secondary Outcomes (3)
Time in Range (TIR)
Change from Baseline at 12 months
Knowledge related to diabetes management
Change from Baseline at 12 months
Awareness of hypoglycemia
Change from Baseline at 12 months
Study Arms (2)
Standard care
ACTIVE COMPARATORGroup in face-to-face session
Online education programme
EXPERIMENTALGroup in online sessions
Interventions
Online group will follow the education programme through videos that they can view at any time and a live session to answer questions.
Face-to-face educacion programme in a group session
Eligibility Criteria
You may qualify if:
- HbA1c ≥7,5%
- More than 3 years of diagnosis
- Ability to follow online sessions
- Having a device to follow up the education programme
You may not qualify if:
- Pregnants
- People on corticosteroid treatment
- People with severe disease
- People with continuous subcutaneous insulin infusion (CSII)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, 08221, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Núria Alonso, RN
Hospital Universitari Mútua Terrassa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2022
First Posted
February 1, 2023
Study Start
December 14, 2022
Primary Completion
July 31, 2023
Study Completion
July 31, 2024
Last Updated
February 1, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share