Zone-Model Predictive Control on the Diabetes Assistant (DiAs) Platform Safety and Feasibility

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Use of Zone-Model Predictive Control (MPC) Controller on the Diabetes Assistant (DiAs) Platform With Fault Detection in Adolescents With Type 1 Diabetes in the Outpatient Setting (UCSB Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02506764
• Other study ID #: IRB 34487
• Status: Not yet recruiting
• Phase: Phase 1
• First received: July 11, 2015
• Last updated: July 22, 2015
• Start date: July 2015

Study information

• Verified date: July 2015
• Source: Stanford University
• Contact: Trang Ly, MBBS PHD
• Phone: 650.215.0732
• Email: trangly[@]stanford.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This clinical trial is designed to test the feasibility of a portable closed-loop artificial pancreas (AP) system using the Zone-Model Predictive Control (MPC) algorithm on the Diabetes Assistant (DiAs) platform in adolescents with type 1 diabetes. The system will also have additional fault detection algorithms designed to detect sensor failure as well as infusion set failure. The fault detection algorithms will be implemented via the remote monitoring software and clinical staff will be alerted to potential failures to assist with clinical care.

Description:

This clinical trial is designed to test the feasibility of a portable closed-loop artificial pancreas (AP) system using the Zone-Model Predictive Control (MPC) algorithm on the Diabetes Assistant (DiAs) platform. The system will also have additional fault detection algorithms designed to detect sensor failure as well as infusion set failure. The fault detection algorithms will be implemented via the remote monitoring software and clinical staff will be alerted to potential failures to assist with clinical care. This information will not be directly communicated to subjects to influence diabetes management in real-time.

The study is a safety and feasibility study to assess the performance of the AP device in a fully supervised study of adolescents with type 1 diabetes over 72 hours. The study will recruit up to 10 subjects, with up to 5 subjects at both Stanford University and University of Colorado. Subjects will reside in a hotel setting where they will sleep overnight and engage in mild to moderate intensity exercise at least twice daily, with clinical staff in attendance at all times. Exercise will include activities such as soccer, basketball, football or gym sessions. Subjects will choose the size, content and timing of their meals to emulate free-living conditions. The primary objective is to ensure that the system is feasible in glucose control in this cohort. Subjects will also wear a Dexcom G4P sensor at home for 72h prior to the start of the hotel admission and this will serve as a control period. This will generate up to 30 days of closed-loop data. Prior to proceeding to the second phase, there will be a DSMB review of the data generated from this initial phase.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 19 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes

2. Daily insulin therapy for at least 12 months

3. Aged between 10.0 to 19.0 years

4. Insulin pump use for at least 3 months

5. Subject is using a downloadable pump

6. Female participants who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD

7. Female participants who have entered menarche must have a negative urine pregnancy test

8. Informed consent form signed by the subject and/or parent and assent signed by the subject if < 18 years

9. Total daily insulin requirement > 0.4 units/kg/day over the preceding two weeks

10. Subject is able to understand and speak English

Exclusion Criteria:

1. 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

2. Diabetic ketoacidosis in the past month

3. History of seizure or loss of consciousness in the last 6 months

4. Subject has a respiratory condition such as asthma, treated with systemic or inhaled corticosteroids in the previous 6 months or cystic fibrosis

5. 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

6. Subject has a history of liver or kidney disease (other than microalbuminuria)

7. Systolic blood pressure > 140 mmHg on screening visit

8. Diastolic blood pressure > 90 mmHg on screening visit

9. Subject has active Graves disease

10. Subjects with inadequately treated thyroid disease or celiac disease

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• Artificial Pancreas using the Zone-Model Predictive Control
Artificial pancreas (AP) system using the Zone-Model Predictive Control (MPC) algorithm on the Diabetes Assistant (DiAs) platform
• Dexcom G4P sensor
Subjects will wear a Dexcom G4P sensor for continuous glucose monitoring, these blood glucose values will not be used to make treatment decisions.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Stanford University	Rensselaer Polytechnic Institute, University of California, San Diego, University of California, Santa Barbara, University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functioning safety alerts	Safety will be determined if system alerts are activated for hypoglycemia (<50 mg/dl) and hyperglycemia (>300 mg/dl) and > 300 mg/dL	72 hours	No
Primary	Functioning system for 75 percent of time of study	Feasibility will be established if the system is functional for at least 75% of the time for the duration of the study.	change over 72 Hours	No