Actively Recruiting
Evaluation of a Mobile AI-powered Decision Support System for Insulin Dosing and Glucose Prediction in Type 1 Diabetes: The glUCModel Clinical Trial Protocol
Led by Universidad Complutense de Madrid · Updated on 2026-01-06
34
Participants Needed
2
Research Sites
46 weeks
Total Duration
On this page
Sponsors
U
Universidad Complutense de Madrid
Lead Sponsor
B
Bioinspired Intelligence SL
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety and efficacy of integrating predictive models into insulin therapy management via the user-centered glUCModel mobile app in People with Type 1 Diabetes Mellitus following Multiple Insulin Dosing therapy. Participants will be aged 18 to 65 years. The main questions it aims to answer are: Does using the app improve glycaemic control, as measured by time in range? Does using the app reduce the number of episodes of hyperglycaemia and hypoglycaemia? Are the app's design and functionality adequate? The study will comprise four phases:ses}): * Screening phase: Informed consent, collection of sociodemographic and clinical data, and baseline Pittsburg, IFIS, and DTSQ questionnaires. * Run-in phase: 2 weeks of standard care with CGM. Data will be used to generate personalized predictive models in the intervention group. * Active treatment phase: Participants continue MDI therapy. The intervention group will additionally use the glUCModel mobile app. CGM data from the final 2 weeks will be analyzed. * Evaluation and analysis phase: Participants will complete the uMARS, Pittsburgh, and DTSQ questionnaires. Statistical analysis and correlations among outcomes will be processed.
CONDITIONS
Official Title
Evaluation of a Mobile AI-powered Decision Support System for Insulin Dosing and Glucose Prediction in Type 1 Diabetes: The glUCModel Clinical Trial Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HbA1c less than 9%
- Currently following a multiple daily insulin injections (MDI) Bolus-Basal therapy
- Using continuous glucose monitors (CGMs) connected to a mobile phone
- Proficient in Spanish language
- Willing to participate in the trial
- Diagnosed with diabetes at least one year ago
- Able to use a mobile application like glUCModel
- Own a mobile phone with Android or iOS operating system
- Able to follow a portion-controlled diet for diabetes
- Educated to actively manage insulin dosing
You will not qualify if you...
- HbA1c 9% or higher
- Not using continuous glucose monitors (CGMs)
- Not proficient in Spanish language
- Diagnosed with diabetes less than one year ago
- Unable to use a mobile application like glUCModel
- Unable to follow a portion-controlled diet for diabetes
- Unable to actively manage insulin dosing
- Diagnosed with a significant psychiatric disorder
- Currently undergoing treatment with corticosteroids
- Hospitalized or had surgery in the last six months
- Pregnant or planning a pregnancy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Universidad Complutense de Madrid
Madrid, Madrid, Spain, 280240
Not Yet Recruiting
2
Hospital Universitario de Toledo
Toledo, Toledo, Spain, 45007
Actively Recruiting
Research Team
I
Ignacio Hidalgo, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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