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An Evaluation of a Novel Glucose Sensing Technology in Type 2 Diabetes

NCT02082184 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2017-05-30

Study results available
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Summary

To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 2 diabetes using insulin.

Conditions

Interventions

DEVICE

Sensor Based Glucose Monitoring System

Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.

DEVICE

Standard Blood Glucose Monitoring

Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.

Sponsors & Collaborators

  • Abbott Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Thomas Haak · Research Institute of Diabetes Academy Mergentheim (FIDAM)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-06-30
Completion
2015-12-31

Countries

  • France
  • Germany
  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT02082184 on ClinicalTrials.gov