MMPPC: A Probabilistic Closed-loop Artificial Pancreas to Handle Unannounced Meals and Exercise

Type 1 Diabetes Clinical Trial

— MMPPC  

Official title:

MMPPC: A Probabilistic Closed-loop Artificial Pancreas to Handle Unannounced

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02480309
• Other study ID #: 15-0272
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2015
• Last updated: December 8, 2016
• Start date: June 2015
• Est. completion date: March 2017

Study information

• Verified date: December 2016
• Source: University of Colorado, Denver
• Contact: David Maahs, MD
• Phone: 303-724-6706
• Email: maahs.david[@]ucdenver.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Device:
• Inpatient use of the MMPPC/DiAs system
An inpatient evaluation of the use of the MMPPC/DiAs system in day and night closed-loop control in adolescents and adults with type 1 diabetes.
• Outpatient use of the MMPPC/DiAs system
An outpatient evaluation of the use of the MMPPC/DiAs system in day and night closed-loop control in adolescents and adults with type 1 diabetes over 2-3 days.

Locations

Country	Name	City	State
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the Safety of the MMPPC/DiAs system<50 mg/dL	No more than two meter glucose values s <50 mg/dL, separated by at least 30 minutes	participants will be followed during inpatient stay an average of 36 hours	Yes
Primary	Evaluate the feasibility of the MMPPC/DiAs system	System initiation and operation at least 75% of the time for 75% of subjects	within 3 hours of enrollment of each subject	No
Primary	Evaluate the efficacy of the MMPPC/DiAs system	The time spent in range 70-180 mg/dL is at least 65% for 80% subjects	participants will be followed during inpatient and hospitals stays an average of 36 and 72 hours respectively	No