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New treatment option for Diabetes (Insulin-requiring, Type 1 or Type 2)
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
ClinicalTrials.gov ID: NCT07304778
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- HbA1c \< 9%
- Currently following an MDI Bolus-Basal therapy.
- Wearing CGMs connected to a mobile phone.
- Spanish language proficiency.
- Willingness to participate in the trial.
You likely can't join if
- HbA1c \< 9%.
- Not wearing CGMs.
- Non-Spanish language proficiency.
- Less than one year since the time of diabetes diagnosis
- Unable to use a mobile application like glUCModel
- Unable to follow a Portion-controlled diet for diabetes
See the full eligibility criteria
- HbA1c \< 9%
- Currently following an MDI Bolus-Basal therapy.
- Wearing CGMs connected to a mobile phone.
- Spanish language proficiency.
- Willingness to participate in the trial.
- At least one year since the time of diabetes diagnosis.
- Ability to use a mobile application like glUCModel.
- Own a mobile phone running Android or iOS operating system.
- Ability to follow a Portion-controlled diet for diabetes.
- Educated to do an active management of insulin dosing
- HbA1c \< 9%.
- Not wearing CGMs.
- Non-Spanish language proficiency.
- Less than one year since the time of diabetes diagnosis
- Unable to use a mobile application like glUCModel
- Unable to follow a Portion-controlled diet for diabetes
- Unable to do an active management of insulin dosing.
- Diagnosed with a significant psychiatric disorder.
- people in treatment with corticoids
- Patients who have required hospitalization or surgery in the last six months.
- Pregnancy or planning a pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
- Toledo, Toledo, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain; Toledo, Toledo, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.