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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Change in Blood Glucose Control Over the Two Study Weeks — 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.

Trial sites (1)