T1 Diabetes Hypoglycemia Prevention Pilot
NCT02682940 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2017-03-03
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
- Diabetes Mellitus, Type 1
- Hypoglycemia
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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