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

NCT06864546 | Recruiting

• 4 other identifiers: CTSPV46-24P2022XSFA7F53D23008460001C53D23007310001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus, Non Insulin Dependent

Keywords

type 2 diabetes; e-health; mathematical modeling; glucose tolerance; continuous glucose monitor; physical activity

Outcome Measures

Primary Outcomes (1)

• Change in Blood Glucose Control Over the Two Study 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

Study Arms (1)

Physical activity intervention

EXPERIMENTAL

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

Interventions

Physical activity intervention BEHAVIORAL

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

Physical activity intervention

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enea Parimbelli: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator
• University of Padova: collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri di Pavia

Pavia, Pavia, 27100, Italy

RECRUITING

Related Publications (3)

• Jackson MA, Ahmann A, Shah VN. Type 2 Diabetes and the Use of Real-Time Continuous Glucose Monitoring. Diabetes Technol Ther. 2021 Mar;23(S1):S27-S34. doi: 10.1089/dia.2021.0007.

  PMID: 33534631 BACKGROUND

• Dehghani Zahedani A, Shariat Torbaghan S, Rahili S, Karlin K, Scilley D, Thakkar R, Saberi M, Hashemi N, Perelman D, Aghaeepour N, McLaughlin T, Snyder MP. Improvement in Glucose Regulation Using a Digital Tracker and Continuous Glucose Monitoring in Healthy Adults and Those with Type 2 Diabetes. Diabetes Ther. 2021 Jul;12(7):1871-1886. doi: 10.1007/s13300-021-01081-3. Epub 2021 May 28.

  PMID: 34047962 BACKGROUND

• Duvivier BM, Schaper NC, Hesselink MK, van Kan L, Stienen N, Winkens B, Koster A, Savelberg HH. Breaking sitting with light activities vs structured exercise: a randomised crossover study demonstrating benefits for glycaemic control and insulin sensitivity in type 2 diabetes. Diabetologia. 2017 Mar;60(3):490-498. doi: 10.1007/s00125-016-4161-7. Epub 2016 Nov 30.

  PMID: 27904925 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Central Study Contacts

Enea Parimbelli

CONTACT

+39 0382 9895981; enea.parimbelli@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor (RTD-A)

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 15, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-03

Locations

IT (1)