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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05708820

Acronym

OPTIM@TE

Enrollment

Registered

2023-02-01

Start date

2022-12-14

Completion date

2024-07-31

Last updated

2023-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type I

Keywords

Diabetes Mellitus, Type I, education programme, online

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
HbA1c	Change from Baseline at 12 months	glycosylated hemoglobin

Secondary

Measure	Time frame	Description
Time in Range (TIR)	Change from Baseline at 12 months	Time spent between 70-180 mg/dl measured by glucose sensor
Knowledge related to diabetes management	Change from Baseline at 12 months	Diabetes Knowledge Questionnaire (DKQ2)- 15 questions with 4 options, high score indicates maximum level of knowledge
Awareness of hypoglycemia	Change from Baseline at 12 months	Clarke Test- 8 questions, ≥ 4 answers with R= reduced awareness

Countries

Spain

Contacts

Primary ContactNúria Alonso-Carril, RN

nuriaalonso@mutuaterrassa.com+34 937365050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026