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
17 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
This research aims to evaluate the safety and effectiveness of integrating predictive models into insulin therapy management through the glUCModel mobile app in adults with Type 1 Diabetes Mellitus who are using Multiple Daily Injections (MDI) therapy. The study focuses on whether using the app improves blood sugar control by increasing the time glucose levels stay within a target range, reducing episodes of high and low blood sugar, and assessing the app's design and usability. The trial is a randomized and open-label study involving participants aged 18 to 65 years. Participants will go through four phases: an initial screening phase to collect consent and baseline data; a 2-week run-in phase where standard care with continuous glucose monitoring (CGM) is followed to create personalized models for those in the app group; an active treatment phase where all continue MDI therapy with the intervention group additionally using the glUCModel app; and a final evaluation phase involving questionnaires and data analysis. CGM data from the last two weeks of treatment will be analyzed to measure outcomes. During the study, participants will complete questionnaires assessing treatment satisfaction and usability, including the Pittsburgh and DTSQ surveys. Researchers will monitor blood sugar levels, counting the frequency and duration of hypo- and hyperglycemic events, glycemic variability, and adherence to app recommendations. The primary outcome is the percentage of time spent in the target glucose range during the last two weeks. The total participation spans from screening through data evaluation, with safety and usability closely monitored throughout.
CONDITIONS
Brief 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 multiple daily injections (MDI) bolus-basal insulin therapy
- Wearing continuous glucose monitors (CGMs) connected to a mobile phone
- Proficient in Spanish language
- Willing to participate in the trial
- At least one year since diabetes diagnosis
- 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 wearing continuous glucose monitors (CGMs)
- Not proficient in Spanish language
- Less than one year since diabetes diagnosis
- 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 treated with corticosteroids
- Hospitalized or had surgery in the last six months
- Pregnant or planning pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 2 weeks
Participants continue their multiple daily injection insulin therapy. Those in the intervention group will also use the glUCModel mobile application to receive AI-powered insulin dosing recommendations and glucose predictions.
Regular use of the mobile app during the treatment period; visit frequency as per standard clinical care
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
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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