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An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT)

NCT02232698 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2017-04-10

Study results available
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Summary

The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 1 diabetes using insulin.

Conditions

  • Type 1 Diabetes Mellitus

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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Sponsors & Collaborators

  • Abbott Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Stephan Matthaei · Diabetes Center Quakenbruck

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Austria
  • Germany
  • Netherlands
  • Spain
  • Sweden

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 NCT02232698 on ClinicalTrials.gov