RecruitingNot ApplicableNCT06864546

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


Sponsor

Enea Parimbelli

Enrollment

20 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study helps people with type 2 diabetes track how different foods and activities affect their blood sugar in daily life. Participants use wearable sensors and get personalized feedback through an app. **You may be eligible if...** - You have type 2 diabetes managed without insulin (either no medication or metformin only) - You are between 40 and 70 years old - You are not very physically active (less than 2.5 hours of moderate exercise per week) - Your HbA1c (a blood sugar control measure) is below 8.5% **You may NOT be eligible if...** - You were diagnosed with diabetes less than 3 years ago - You use insulin or other diabetes medications besides metformin - You have serious heart, kidney, or vision complications from diabetes - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPhysical activity intervention

In the first week, patients will be asked to maintain their normal sedentary life, spending most of the waking day sitting. During the second week, participants will be asked to take at least 10,000 steps/day, with sitting replaced by standing and light-intensity walking. See doi: 10.1007/s00125-016-4161-7


Locations(1)

Istituti Clinici Scientifici Maugeri di Pavia

Pavia, Pavia, Italy

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NCT06864546