Actively Recruiting

Phase Not Applicable
Age: 40Years - 70Years
All Genders
NCT06864546

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

Led by Enea Parimbelli · Updated on 2025-04-30

20

Participants Needed

1

Research Sites

37 weeks

Total Duration

On this page

Sponsors

E

Enea Parimbelli

Lead Sponsor

I

Istituti Clinici Scientifici Maugeri SpA

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with type 2 diabetes not treated with insulin or only treated with metformin
  • Physically inactive, with less than 150 minutes per week of moderate physical activity
  • Age between 40 and 70 years
  • HbA1c level below 8.5%
Not Eligible

You will not qualify if you...

  • Diabetes diagnosis less than 3 years before study start
  • Pregnancy
  • Symptomatic heart disease such as past heart attack, coronary bypass, stenting, angina, or stroke
  • Use of medications that affect glucose metabolism, including oral steroids
  • Use of medications that significantly lower heart rate, including beta blockers and others
  • Presence of atrial fibrillation
  • Use of an electronic pacemaker

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Istituti Clinici Scientifici Maugeri di Pavia

Pavia, Pavia, Italy, 27100

Actively Recruiting

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Research Team

E

Enea Parimbelli

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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