Assessment of an Automatic Closed-loop Insulin Delivery System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- Stanford University
- Enrollment
- 21
- Locations
- 3
- Primary Endpoint
- Safety of Automatic Closed Loop Insulin Delivery System in Adolescents and Adults With Type 1 Diabetes
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The overall aim of this research proposal is to determine the safety, feasibility and efficacy of an automatic closed-loop insulin delivery system.
Detailed Description
This study will be completed in two parts. The initial part of this study will be an inpatient evaluation of the system with the primary goal of assessing safety and feasibility. This will involve 8 subjects with type 1 diabetes, aged 14 - 40 years, admitted for up to 60 hour. Plasma glucose levels will be collected hourly and tested by YSI (YSI 2300, Yellow Springs Instrument). These studies will be performed at Stanford University and will include group sporting activities to mimic the diabetes camp environment. Capillary blood glucose testing will be performed every 2-3 hours before meals, snacks, exercise, and prebed by subjects with research staff supervision during the day and at 00:00, 03:00 and 07:00 by research staff. These data will be reviewed by the DSMB before proceeding to camp studies. The second part of this study will be to test the efficacy of the system during diabetes summer camps. We will test the system in subjects with type 1 diabetes, aged 14-40 years, attending diabetes camp. There will be 20 subjects recruited, with 10 subjects randomized to the control arm Medtronic 530G system with threshold suspend (control group) and 10 subjects randomized to the automatic closed-loop insulin delivery (intervention group). Capillary blood glucose testing will be performed every 2-3 hours before meals, snacks, exercise and prebed by subjects with research staff supervision and at 00:00, 03:00 and 07:00 by research staff. The primary aim of this study is to generate preliminary data of system safety and efficacy in a closely supervised environment that challenges glucose control.
Investigators
Bruce A. Buckingham
MD
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of type 1 diabetes
- •The diagnosis of type 1 diabetes is based on the investigator's judgment
- •C peptide levels and antibody determinations are not required
- •Daily insulin therapy for ≥ 12 months
- •Insulin pump therapy for ≥ 3 months
- •Age 14.0 - 40.0 years
- •Subject comprehends written English
- •Female subjects who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD
- •Female subjects past menarche must have a negative urine pregnancy test
- •Informed consent form is signed by the subject and/or parent and assent assigned by the subject if under 18 years of age
Exclusion Criteria
- •Subject has a medical disorder that in the judgment of the investigator will affect the wearing of the devices or the completion of any aspect of the protocol
- •Diabetic ketoacidosis in the past month
- •Hypoglycemic seizure or loss of consciousness or an event requiring glucagon or IV glucose in the past 3 months
- •Subject has a respiratory condition such as asthma, treated with systemic or inhaled corticosteroids in the previous 6 months or cystic fibrosis
- •Subject has a history of any cardiac or vascular disorder such as myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, arrhythmia or thromboembolic disease
- •Subject has a history of liver or kidney disease (other than microalbuminuria)
- •Subject has active Graves' disease
- •Subjects with inadequately treated thyroid disease or celiac disease
- •Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
- •Subject has a history of diagnosed medical eating disorder
Outcomes
Primary Outcomes
Safety of Automatic Closed Loop Insulin Delivery System in Adolescents and Adults With Type 1 Diabetes
Time Frame: 6 days
1. As measured by the number of events of plasma glucose values ≤ 50 mg/dL OR frequency of system alerts preceding a plasma glucose value of ≤ 50 mg/dL in all subjects 2. As measured by the number of events of system alerts of plasma glucose values \>300 mg/dL lasting for more than one hour in all subjects. 3. As measured by number of events of serum ketones \>3 mmol/L in all subjects 4. As measured by the number of events meeting the criteria for severe hypoglycemia, defined as hypoglycemic seizure, loss of consciousness or coma or an event requiring administration of glucagon or IV glucose in all subjects
Secondary Outcomes
- Feasibility of Using the Automatic Closed Loop Delivery System in Adolescents and Adults With Type 1 Diabetes(6 days)
- Efficacy of Hybrid Closed-loop System in Comparison With Control(6 days)