CClinicalTrials.gg
Status unknownNCT05708820OPTIM@TEUpdated Feb 1, 2023

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

An interventional study of Online education programme and Standard education programme in Diabetes Mellitus, Type I, sponsored by Hospital Mutua de Terrassa. Status unknown at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-01.

Sponsored by Hospital Mutua de Terrassa · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type I

Keywords

  • Diabetes Mellitus, Type I
  • education programme
  • online
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Hospital Mutua de Terrassa is the lead sponsor of 33 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pregnants
  • People on corticosteroid treatment
  • People with severe disease
  • People with continuous subcutaneous insulin infusion (CSII)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Standard care

    Group in face-to-face session

    Behavioral: Standard education programme

  • Experimental
    Online education programme

    Group in online sessions

    Behavioral: Online education programme

Interventions

  • BehavioralOnline education programme

    Online group will follow the education programme through videos that they can view at any time and a live session to answer questions.

  • BehavioralStandard education programme

    Face-to-face educacion programme in a group session

06

What researchers measure

Primary outcomes

  1. HbA1c

    glycosylated hemoglobin

    Time frame: Change from Baseline at 12 months

Secondary outcomes

  1. Time in Range (TIR)

    Time spent between 70-180 mg/dl measured by glucose sensor

    Time frame: Change from Baseline at 12 months

  2. Knowledge related to diabetes management

    Diabetes Knowledge Questionnaire (DKQ2)- 15 questions with 4 options, high score indicates maximum level of knowledge

    Time frame: Change from Baseline at 12 months

  3. Awareness of hypoglycemia

    Clarke Test- 8 questions, ≥ 4 answers with R= reduced awareness

    Time frame: Change from Baseline at 12 months

07

Study locations

2 of 2 sites recruiting
  • Hospital Mutua de Terrassa
    Terrassa, Barcelona 08221, Spain
    • Endocrinology Unit · Contact
    • Núria Alonso, RN · Principal investigator
    Recruiting
  • Hospital Universitari Mútua de Terrassa
    Terrassa, Barcelona 08221, Spain
    • Núria Alonso-Carril, RN · Contact
    • Núria Alonso · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05708820
Lead sponsor
Hospital Mutua de Terrassa
Responsible party
Sponsor
First posted
Feb 1, 2023
Start date
Dec 14, 2022
Primary completion
Jul 31, 2023 (estimated)
Completion
Jul 31, 2024 (estimated)
Last update
Feb 1, 2023

Study contacts

Núria Alonso-Carril, RN
Contact
nuriaalonso@mutuaterrassa.com
+34 937365050 ext. 11330
Núria Alonso, RN
principal investigator · Hospital Universitari Mútua Terrassa

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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