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

Stopped early · Not applicable

Conditions studied: Hypoglycemia, Diabetes Mellitus, Type 1

In brief

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

Key facts

Study ID

NCT02906891

Run by

InSpark Technologies, Inc.

People needed

13

Starts

2016-05-01

Expected to finish

2016-12-01

Last updated by the study team

2017-03-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• • Male or female participants aged between 18 and 75 years
• Clinical diagnosis of type 1 diabetes mellitus and using multiple daily injections or CSII for at least six months
• Patient has had documented nocturnal hypoglycemia in the last 2 months with an associated blood sugar reading less than 56mg/dL. Night is defined as the 8 hour interval when the patient usually sleeps (I.e. 11:00 pm to 7:00 am, for example).
• OR
• Patient has had at least 1 severe low at night in the last 6 months (helped by another). Night is defined as the 8 hour interval when the patient usually sleeps (I.e. 11:00 pm to 7:00 am, for example).
• Willing to monitor and record signs and symptoms of hypoglycemia
• Willing to test blood glucose levels at least three times a day
• Ability to use Android or IOS mobile phone
• No CGM Users

You may not qualify if…

• • Pregnancy
• Unable to use the technology
• Any condition that in the investigators judgment is likely to cause the participant to be unable e 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 data

Where it is running

• East Carolina University — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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