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Telemedical Devices in the Management of Type 2 Diabetes Mellitus to Improve Diabetic Control and Quality of Life

NCT04038528 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2019-07-31

No results posted yet for this study

Summary

The aim of this study is to understand, in adult patients with Type 2 diabetes mellitus, if the use of telemedicine (monitoring and treatment without patients having to attend a healthcare facility) and home-based care is more effective than traditional general practitioner (GP) and outpatient care in terms of patients taking medication regularly and their quality of life.

The hypothesis of this study is that patients with Type 2 diabetes mellitus uploading data on a telemedicine system achieve a glycemic control, evaluated in terms of glycated hemoglobin levels, similar to that of patients followed in a traditional diabetes outpatient department, with improvements to quality of life

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

telemonitoring of T2DM

Baseline record of: * Weight * Height * BMI * Abdominal circumference * Winsor Index * ECG * Retinography * Blood level of (fasting values): total cholesterol, HDL cholesterol, LDL cholesterol, blood sugar, triglycerides, glycated hemoglobin These parameters will be checked again at 3, 6 and 18 months in the two groups. Telemedicine group (intervention): * Blood sugar (two measurements per week). * Body weight (weekly) * Blood pressure (weekly) Use of devices that allow the automatic upload of data via wi-fi or web is allowed Control group (control): Routine appointments scheduled by their GPs and specialists in outpatient clinics to record blood sugar levels as per standard GP or specialist physician's indications. Blood sugar level is measured in mg/dl in a drop of capillary blood with the use of standard glucose meter

Sponsors & Collaborators

  • GPI SpA

    collaborator UNKNOWN

  • Centro Studi Internazionali, Italy

    lead NETWORK

Principal Investigators

  • Antonio V Gaddi, MD, PhD · EuroGenLab, Bologna, Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2020-03-01
Completion
2020-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04038528 on ClinicalTrials.gov