Aurora, Colorado 80045


Purpose:

To determine the safety, feasibility and efficacy of the Multiple Model Probabilistic Predictive Control / Diabetes Assistant (MMPPC/DiAS) system in full day and night closed-loop control in adolescents and adults with type 1 diabetes. This will be addressed in two parts. There will be an initial 36 hour inpatient study with hourly plasma glucose monitoring and scheduled exercise and meals. If the system is shown to be safe, feasible and effective, the study will proceed to supervised hotel studies with remote monitoring to test system use over 3 days/2 nights.


Study summary:

To further develop and refine an artificial pancreas system using the MMPPC framework that the investigators have developed. The MMPPC controller has been tested in a number of in silico studies as well as a small cohort of clinical studies. The controller is unique compared to other closed-loop systems in that it does not require meal announcement or a priming dose of insulin prior to a meal and is therefore a fully closed-loop system. Initial results were encouraging and the investigators achieved acceptable glucose control during the day and night. With this protocol, the investigators will further test the algorithm, as well how well the algorithm operates within an automated, portable closed-loop device, the DIAS in clinical studies. The DIAS system is able to use glucose sensor input and communicate to an insulin pump. The algorithm is incorporated within an Android phone, which determines insulin delivery. The studies will involve an initial inpatient phase, with frequent plasma glucose monitoring and proceed to supervised, remotely-monitored studies in a hotel setting.


Criteria:

Inclusion Criteria: 1. Clinical diagnosis of type 1 diabetes - The diagnosis of type 1 diabetes is based on the investigator's judgment; - C peptide level and antibody determinations are not needed. 2. Daily insulin therapy for at least 12 months 3. Age between 14.0 to 55.0 years of age. 4. Subject has used a downloadable insulin pump for at least 3 months. 5. Subject comprehends written English. 6. Female patients who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD 7. Female patients must have a negative urine pregnancy test 8. Informed consent form signed by subjects aged ≥ 18 years 9. Parent/guardian (for subjects < 18 years) and subject understand the study protocol and agree to comply with it. Both parents must sign if possible. 10. Total daily insulin requirement should be at least 0.4 units/kg/day Exclusion Criteria: 1. Diabetic ketoacidosis in the past month 2. History of seizure or loss of consciousness in the previous 6 months 3. Subject has a respiratory condition such as asthma, if treated with systemic corticosteroids in the previous 6 months, or cystic fibrosis 4. 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 5. Subject has a history of liver or kidney disease (other than microalbuminuria) 6. Systolic blood pressure > 140 mmHg on screening visit 7. Diastolic blood pressure > 90 mmHg on screening visit 8. Subject has active Graves disease with a suppressed Thyroid Stimulating Hormone 9. Subjects with inadequately treated thyroid disease or celiac disease 10. Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol 11. Either the subject or the subject's primary caregiver has received inpatient psychiatric treatment in the past 6 months 12. Subject has a history of diagnosed medical eating disorder 13. Subject has a history of known illicit drug abuse 14. Subject has a history of known prescription drug abuse 15. Subject has a history of current alcohol abuse 16. Subject has a history of visual impairment which would not allow subject to participate


NCT ID:

NCT02480309


Primary Contact:

Principal Investigator
David Maahs, MD
University of Colorado, Denver

David Maahs, MD
Phone: 303-724-6706
Email: maahs.david@ucdenver.edu


Backup Contact:

Email: laurel.messer@ucdenver.edu
Laura Messer, RN, MPH
Phone: 303-724-6742


Location Contact:

Aurora, Colorado 80045
United States



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Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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