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

April 25, 2025 updated by: Enea Parimbelli

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Diabetes Mellitus (DM) represents one of the major and fastest growing global health emergencies. Approximately 90% of the individuals with DM are affected by type 2 diabetes (T2D), whose management usually begins with lifestyle interventions, then progressing to one or more antihyperglycemic, while only ultimately moving to insulin therapy. Focusing on non-insulin treated T2D, evidence has shown lifestyle modifications, including exercise, healthy diet and education, to be effective in reversibility of the disease, but also in preventing the transition to T2D in high-risk (healthy) individuals. This would call for the improvement of participatory medicine, exploiting the increase in smartphone use over the past decade. In this framework, technological platforms would be key for the development of personalized, patient-centered interventions that integrate patient-reported data, tailored education, and individualized feedback. A fundamental component of these technological platforms for participatory medicine in diabetes is represented by continuous glucose monitoring (CGM) devices. These devices, usable in real-life conditions, provide prompt information on glucose trends and variability, warnings for out of-range glucose values as well as the ability for physicians to remotely review glucose profiles. Numerous studies have shown benefits of using CGM devices mainly in T1D but recently also in advanced T2D, while only limited data is available in non insulin treated T2D. The increasing accuracy of these devices paved the way for the development of tools assessing glucose tolerance in real-life conditions. The development of these tools would be highly beneficial for patients with T2D, allowing to provide information on therapy effectiveness and, possibly, disease progression. Moreover, incorporation of these tools into technological platforms, empowering participatory interventions and supporting self-management, would be fundamental for both the patients and the healthcare system.

The aim of the GluToTrack project is to combine bioengineering mathematical models and a data collection platform based on m-health solutions to develop a tool for glucose tolerance tracking, as well as evaluating the impact of individuals' daily activities like exercise on it, from PGHD and CGM data collected in real-life conditions. Data, required for the mathematical model validation phase, will be gathered, exploiting an e-health approach combining medical informatics and medical device wearables, running an in vivo clinical trial in a population of 20 patients with non-insulin treated T2D.

The clinical trial is an interrupted time series analysis. The trial seeks to enroll 20 participants with non-insulin treated T2D, 40 to 70 years old and physically inactive (less than 150 min/week of moderate physical activity).

During the first visit (visit 1, day 0) routine vital signs will be registered, and wearables (a CGM device and an activity tracker) and smartphones provided. The study is structured in two 1-week-long phases: in the first week patients will be asked to maintain their already sedentary lifestyle, while during the second week, participants should take at least 10,000 steps/day, with sitting replaced by standing and light-intensity walking, for a total of at least 150 min/week of light physical activity. At the end of the first week (visit 2, day 7) participants undergo an MMTT, which consists in the ingestion of a meal containing 75 g of carbohydrates and the drawing of 10 plasma samples for the measurement of plasma glucose, insulin and C-peptide concentrations. At the end of the second week (visit 3, day 14), subjects will repeat the MMTT to also assess the potential impact of the physical activity intervention on glucose tolerance.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • Istituti Clinici Scientifici Maugeri di Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Behavioral: Physical 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Glucose Control Over the Two Study Weeks
Time Frame: From enrollment to the end of the treatment at 2 weeks

The estimation of the Disposition Index (DI) requires plasma measurements in hospitalized setting. The investigators propose a model able to estimate the DI from CGM data collected in outpatient condition.

The DI (index of glucose tolerance) quantified using mathematical models from patient generated health data and CGM data, and the reference one, from plasma measurements, will be calculated to assess if these are affected or not by physical activity. Also the area under the glucose curve measured by CGM device will be evaluated to assess the intervention effect.
From enrollment to the end of the treatment at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enea Parimbelli

Collaborators

University of Padova
Istituti Clinici Scientifici Maugeri SpA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 15, 2026

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTSPV46-24
  • P2022XSFA7 (Other Grant/Funding Number: PRIN 2022 PNRR - MIUR (Italian Ministry of University and Research))
  • F53D23008460001 (Other Grant/Funding Number: CUP UO UNIPV Pavia)
  • C53D23007310001 (Other Grant/Funding Number: CUP master)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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