T1 Diabetes Hypoglycemia Prevention Pilot

NCT02682940 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-03-03

No results posted yet for this study

Summary

A single center pilot study assessing the Vigilant Diabetes Management System for the prevention of recurrent mild to moderate hypoglycemia in type I diabetes patients.

Conditions

Interventions

DEVICE

Vigilant Diabetes Management Application

Subjects will download the Vigilant Diabetes Management 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

  • Atlanta Diabetes Associates

    collaborator OTHER
  • InSpark Technologies, Inc.

    lead INDUSTRY

Principal Investigators

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

  • Bruce Bode, MD · Atlanta Diabetes Associates

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
74 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

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Entities

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 NCT02682940 on ClinicalTrials.gov