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A Pilot Study of Nocturnal Hypoglycemia Prevention in Type 1 Diabetes Using the Vigilant Diabetes Management Companion

NCT02906891 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-03-03

No results posted yet for this study

Summary

A single center pilot study assessing the Vigilant Diabetes Management Companion for the prevention of recurrent nocturnal hypoglycemia in type I diabetes patients.

Conditions

Interventions

DEVICE

Vigilant Diabetes Management Application

The Vigilant Diabetes Management Companion by InSpark Technologies was developed to assist in the prevention of hypoglycemia by providing the individual with an unobtrusive analysis of their blood glucose values and notifying them about periods of upcoming risk for low and high blood glucose; and in particular periods of risk for severe hypoglycemia. This allows the individual to take preventive corrective action. Subjects will download the Vigilant DiabetesManagement Application and use it in conjunction with a study supplied wireless blood glucose meter. They will check blood glucose values at least three times a day and receive summaries and notifications from Vigilant regarding periods of risk and blood glucose patterns.

Sponsors & Collaborators

  • East Carolina University

    collaborator OTHER

  • InSpark Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Laurel Fuqua, RN, MSN · InSpark Technologies, Inc.

  • Robert Tanenberg, MD · East Carolina University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02906891 on ClinicalTrials.gov