Development of Algorithms for a Hypoglycemic Prevention Alarm: Closed Loop Study

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being conducted at Stanford University Medical Center and the University of Colorado Barbara Davis Center. It is paid for by the Juvenile Diabetes Research Foundation. The purpose of doing this research study is to understand the best way to stop an insulin infusion pump from delivering insulin to prevent a subject from having hypoglycemia. Nocturnal hypoglycemia is a common problem with type 1 diabetes. This is a pilot study to evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor communicating wirelessly with a bedside computer running an algorithm that temporarily suspends insulin delivery when hypoglycemia is predicted in a home setting.

Key facts

Study ID

NCT00884611

Run by

Stanford University

People needed

20

Starts

2007-05-01

Expected to finish

2011-08-01

Last updated by the study team

2018-02-28

Who can join

Age: 12 and older, up to 46. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older,
• Type 1 diabetes for at least 1 year
• Current user of the MiniMed Paradigm Real-Time Revel system and Sof-sensor glucose sensor
• Hemoglobin A1c level of < 8.0%,
• Home computer with access to the Internet,
• At least one CGMglucose value < 70 mg/dL during the most recent 15 nights of CGM glucose data.
• Not pregnant or planning to become pregnant

You may not qualify if…

• The exclusion criteria for this study is the following:
• The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
• The presence of any of the following diseases:
• Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
• Cystic fibrosis
• Angina (recurrent heart pain)
• Past heart attack or coronary artery (heart vessel) disease
• Past stroke or impairment of blood flow to the brain
• Other major illness that in the judgment of the investigator might interfere with the completion of the protocol Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
• Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
• Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
• Severe hypoglycemic event, as described as a seizure, loss of consciousness, severe neurological impairment, or neurological impairment suggestive of hypoglycemia and requiring an emergency department visit or hospitalization within 18 months of enrollment.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States
• Barbara Davis Center for Childhood Diabetes, University of Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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