Trial Search Results

Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study

The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp setting will allow us to obtain pilot efficacy data.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

University of Virginia

Collaborator: Stanford University

Stanford Investigator(s):

Intervention(s):

  • Device: Diabetes Assistant (DiAs)
  • Device: Tandem t:slim Insulin Pump
  • Device: Dexcom G4 Platinum sensor

Phase:

N/A

Eligibility


Inclusion Criteria:

   1. 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

   2. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide
   levels and antibody determinations are not required.

   3. Age 10.0 - 35 years

   4. Willingness to use a Sure-T or Contact Detach infusion set while at camp

Exclusion Criteria:

   1. Diabetic ketoacidosis in the past month

   2. Hypoglycemic seizure or loss of consciousness in the past 3 months

   3. History of seizure disorder (except for hypoglycemic seizure)

   4. Using an OmniPod insulin infusion pump

   5. History of any heart disease including coronary artery disease, heart failure, or
   arrhythmias

   6. Cystic fibrosis

   7. 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.

   8. History of ongoing renal disease (other than microalbuminuria).

   9. Insulin pump users who supplement with injected intermediate or long acting insulin.

10. Subjects who take other anti-diabetic medications other than insulin..

11. Medical or psychiatric condition that in the judgment of the investigator might
   interfere with the completion of the protocol such as:

12. Inpatient psychiatric treatment in the past 6 months

13. Uncontrolled adrenal disorder

14. Abuse of alcohol

15. Pregnancy (verbal denial of pregnancy obtained with telephone informed consent,
   pregnancy test performed at camp before study devices are assigned).

16. Sexually active females who do not practice acceptable contraceptive methods to
   prevent pregnancy.

Ages Eligible for Study

10 Years - 35 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting