An Outpatient Pump Shutoff Pilot Feasibility and Safety Study

Completed · Phase 2

Conditions studied: Type 1 Diabetes

In brief

The purpose of this study is to evaluate an overnight system that will turn off the insulin pump automatically if the system predicts that a low blood sugar is likely. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur. We have tested this system overnight in the hospital and are ready to test the system in the home environment to learn more about how well it will work and to make sure that the blood sugar does not go too high when the pump shuts off. This study has several phases and will take about a month or a little more for a patient to complete. Patients will use the study system for about 5 days at home to show that the patient is able to use it correctly. After that, the patient will be asked to use the study system each night for an additional 3-4 weeks. During this time, the system will be active for two-thirds of the nights and not active for one-third of the nights. When the system is active and predicts that your blood sugar will become low, the insulin pump will shut off for up to 2 hours. The study will include 2 clinical centers in the United States.

Key facts

Study ID: NCT01736930
Run by: Jaeb Center for Health Research
People needed: 20
Starts: 2012-01-01
Expected to finish: 2012-06-01
Last updated by the study team: 2016-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months
Age >=18.0 years
HbA1c <=8.0%
Availability of internet access for periodic upload of study data
Experience using the Medtronic pump and CGM and investigator is confident that subject will use CGM on a near-daily basis during the study
Nocturnal hypoglycemia meeting the following criterion based on CGM download: during the most recent 15 nights with CGM glucose data (must be within the past 42 days), one or more nights with a sensor glucose value <=70 mg/dL.

You may not qualify if…

Diabetic ketoacidosis in the past 3 months
Hypoglycemic seizure or loss of consciousness in the past 6 months
History of seizure disorder (except for hypoglycemic seizure)
Coronary artery disease or heart failure
Cystic fibrosis
Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
History of ongoing renal disease (other than microalbuminuria). Creatinine level to have been obtained within the last year if subject has diabetes of >10 years duration or is over 50 years of age. If creatinine is > 1.5 mg/dL, the subject is excluded.
History of liver disease
Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as: inpatient psychiatric treatment in the past 6 months, uncontrolled adrenal disorder, and/or abuse of alcohol
Pregnancy: A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.

Where it is running

Stanford University — Stanford, California, United States
Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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