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DIgital Assisted MONitoring for DiabeteS - I

NCT01804803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2020-06-04

No results posted yet for this study

Summary

The study aims to validate the clinical efficacy of a telemedicine- and web-based system platform for Self-monitoring of blood glucose (SMBG) data transmission and analysis in terms of improved metabolic control, assessed by measuring changes in HbA1c, in insulin-treated diabetic patients. The system platform involves (i.) systematic (real-time and anywhere) transmission of SMBG data to a decision supported software (DSS)-assisted server, (ii.) web-based analysis of data, and (iii.) feedback on patients and medical staff to implement metabolic control. The expected outcome is that using this telemedicine-based system with transmission of SMBG data, web-based analysis of data and medical feedback to patients and medical team will improve glucose control in insulin-treated individuals with type 1 or type 2 diabetes mellitus.

Conditions

Interventions

PROCEDURE

Use of software-implemented glucometer for real-time collection and transmission of measured glucose values to remote server.

Device is a smartphone-connected glucometer. The smartphone will be implemented with a software for real-time collection and transmission of measured glucose values to the remote server. Thus, the glucometer will be made "hot" for real-time and anywhere data transmission. In addition, at the time of blood glucose measuring, the patient will enter information on whether the measurement is being performed in the pre-prandial, post-prandial or absorptive periods, and will indicate which meals the measurement refers to (i.e., breakfast, lunch, dinner, snack). SMBG results will be immediately transmitted to the remote server, which will perform data collection and analysis, and provide feed-back to the patient and the medical staff according to pre-defined specific algorithms (Decision Supported Software, DSS).

PROCEDURE

Use of regular glucometer

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • LifeScan

    collaborator INDUSTRY

  • University of Bari

    lead OTHER

Principal Investigators

  • Francesco Giorgino, M.D., Ph.D. · University of Bari Aldo Moro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-09
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Italy

Study Locations

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Entities

Diseases
Companies

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 NCT01804803 on ClinicalTrials.gov