T1 Diabetes Hypoglycemia Prevention Pilot

Stopped early · Not applicable

Conditions studied: Diabetes Mellitus, Type 1, Hypoglycemia

In brief

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.

Key facts

Study ID

NCT02682940

Run by

InSpark Technologies, Inc.

People needed

4

Starts

2016-05-01

Expected to finish

2016-12-01

Last updated by the study team

2017-03-03

Who can join

Age: 11 and older, up to 74. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male \& female ages 11-74
• At least 10% of readings are hypoglycemia (<70mg/dL) in meter download
• Clinical diagnosis of T1 DM
• MDI (Multiple Daily Insulin Injections) or CSII (Continuous Subcutaneous Insulin Infusion) for at least six months
• Willing to monitor and records signs \& symptoms of hypo
• SMBG (Self Monitoring Blood Glucose) at least three per day for last 30 days
• Ability to use Android or IOS mobile phone
• No CGM (Continuous Glucose Monitoring) Users

You may not qualify if…

• Pregnancy
• Unable to use the technology (no Android / iOS device)
• Any condition that in the investigators judgment is likely to cause the participant to be unable to understand or provide informed consent
• Unwilling to use SMBG at least three times a day
• Unwilling to monitor and record signs and symptoms of hypoglycemia
• Individuals who are unwilling to share their glucose meter
• Active CGM or anticipated use of CGM if in the study
• Severe visual impairment

Where it is running

• Atlanta Diabetes Associates — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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