A Participatory Approach to Support Glucose Tolerance Tracking in Real-Life of Patients With Type 2 Diabetes
Recruiting · NCT06864546 · Interventional (participants receive a specific treatment) · Lead sponsor: Enea Parimbelli
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Recent studies show that lifestyle interventions, such as exercise, healthy diet, and education, can help prevent type 2 diabetes in high-risk individuals, and even reverse the disease in its early stages. However, not many methods have been developed to use modern technology to help people manage their diabetes in a more active way, in line with participatory medicine, where patients play a key role in their treatment. In this study, the investigators propose an e-health approach to automatically collect health data from patients, including information from continuous glucose monitor (CGM) and other health tracking devices, in real-life conditions. The investigators will also develop a simple and easy-to-understand tool to track patient's metabolic status and will analyze how it relates to lifestyle changes using the data collected during the study. Twenty sedentary individuals with type 2 diabetes, not on insulin treatment, will take part in the trial. All patients will be monitored for two weeks using a CGM device and an activity tracker. During the first week, participants will follow their normal daily routine, while in the second week, subjects will be asked to engage in moderate physical activity every day, consisting of walking. At the end of each week, patients will take a meal tolerance test. The main goal of the study is to measure how blood sugar levels change over the two weeks, also evaluating the impact of individuals' daily activities like exercise on it. The research team will develop and use mathematical models to measure this change. A secondary goal is to evaluate the ease of use of the e-health system for data collection.
Who can take part
Inclusion criteria
- Non-insulin treated T2D diagnosis (not treated at all or only with metformin);
- Physically inactive (less than 150 minutes/week of moderate physical activity);
- Age between 40 and 70;
- HbA1c below 8.5%.
Exclusion criteria
- Diabetes diagnosis less than 3 years before the study initiation;
- Pregnancy;
- Symptomatic heart disease, e.g. history of myocardial infarction, coronary bypass, stenting procedure, angina, or any ischemic cerebrovascular event;
- Use of a medication that significantly impacts glucose metabolism (oral steroids);
- Use of a medication that significantly lowers heart rate (beta blockers, reserpine, guanethidine, methyldopa, clonidine, cimetidine, digitalis, calcium channel blockers, amiodarone, antiarrhythmic drugs, or lithium);
- Atrial fibrillation;
- Use of an electronic pacemaker.
Where it is running
1 location listed.
- Istituti Clinici Scientifici Maugeri di Pavia - Pavia, Pavia, Italy