Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Artificial Pancreas Project, Diabetes Mellitus, Type 1, Insulin pump therapy, Continuous Glucose Monitors (CGM), Juvenile-Onset Diabetes, Autoimmune Diabetes, Closed-to-Range, Diabetes Assistant (DiAs)
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and a Medtronic, Animas or Tandem insulin infusion pump for at least 3 months
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide levels and antibody determinations are not required.
- Age 10.0 - 35 years
- Willingness to use a Sure-T or Contact Detach infusion set while at camp
Exclusion Criteria:
- Diabetic ketoacidosis in the past month
- Hypoglycemic seizure or loss of consciousness in the past 3 months
- History of seizure disorder (except for hypoglycemic seizure)
- Using an OmniPod insulin infusion pump
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- 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).
- Insulin pump users who supplement with injected intermediate or long acting insulin.
- Subjects who take other anti-diabetic medications other than insulin..
- 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 (verbal denial of pregnancy obtained with telephone informed consent, pregnancy test performed at camp before study devices are assigned).
- Sexually active females who do not practice acceptable contraceptive methods to prevent pregnancy.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Closed-Loop Control with DiAs System
Control Group, Sensor-Augmented Pump Therapy
Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.
Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.