A Participatory Approach to Support Glucose Tolerance Tracking in Real-Life of Patients With Type 2 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 70
Healthy Volunteers: f
View:

• 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%.

Locations
Other Locations
Italy
Istituti Clinici Scientifici Maugeri di Pavia
RECRUITING
Pavia
Contact Information
Primary
Enea Parimbelli
enea.parimbelli@unipv.it
+39 0382 9895981
Time Frame
Start Date: 2025-05
Estimated Completion Date: 2026-01-15
Participants
Target number of participants: 20
Treatments
Experimental: Physical activity intervention
Study participants will be monitored for two weeks with a CGM device and an activity tracker. During the first week, participants will follow their usual daily routine, while in the second week, subjects will be asked to engage in daily physical activity, consisting of walking
Related Therapeutic Areas
Sponsors
Collaborators: University of Padova, Istituti Clinici Scientifici Maugeri SpA
Leads: Enea Parimbelli

This content was sourced from clinicaltrials.gov