Status:
COMPLETED
Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
3-14 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a continuous glucose moni...
Detailed Description
Patients who are eligible for the clinical trial initially will use a Veo insulin pump and Enlite sensor at home to verify that the patient is able to use the continuous glucose monitor (CGM) and inse...
Eligibility Criteria
Inclusion
- 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 3 to \<15 years
- HbA1c \<=8.5%
- Availability of internet access for periodic upload of study data
Exclusion
- Diabetic ketoacidosis in the past 3 months
- Hypoglycemic seizure or loss of consciousness in past 6 months
- History of seizure disorder (except for hypoglycemic seizures)
- 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), or liver disease (Creatinine is \> 1.5 mg/dL (132 µmol/L))
- 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
- Abuse of alcohol
- Pregnancy
- Liver disease as defined by an Alanine Aminotransferase Test (ALT) greater than 3 times the upper limit of normal
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01823341
Start Date
May 1 2013
End Date
September 1 2014
Last Update
August 30 2016
Active Locations (3)
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1
Stanford University
Stanford, California, United States, 94305
2
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
3
St. Joseph's Health Care
London, Ontario, Canada, N6A4V2