Inpatient Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the APS APP

Sansum Diabetes Research Institute1 site in 1 country6 target enrollmentFebruary 28, 2018

ConditionsType 1 Diabetes Mellitus

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Type 1 Diabetes Mellitus
Sponsor: Sansum Diabetes Research Institute
Enrollment: 6
Locations: 1
Primary Endpoint: Percent time in glucose range 70-180 mg/dL
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical trial is a safety and feasibility study to assess the performance of artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the APS APP platform.

Detailed Description

The system will be evaluated on up to 10 adult subjects with type 1 diabetes age 18-75 years old at a single clinical site (Sansum Diabetes Research Institute), who will complete a 48-hour closed-loop (CL) session in an observed CRC environment with medical staff present. During the session subjects will bolus for all meals and snacks and perform a 45-minute walking session while supervised by medical staff. The AP system used consists of an insulin pump, a CGM sensor, and a phone app (the Artificial Pancreas System \[APS\] phone app).

Registry

clinicaltrials.gov

Start Date

February 28, 2018

End Date

September 4, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sansum Diabetes Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 and ≤ 75 years at the time of screening.
•Clinical diagnosis of type 1 diabetes for at least one year.
•Has been using an insulin pump for at least 6 months at the time of screening.
•HbA1c \< 10.5%.
•Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate.
•Willing to perform at least 7 fingerstick blood glucose tests a day.
•If using Apidra (insulin glulisine) at home and planning to use the Tandem t:AP pump for the closed-loop session, willing to switch to Novolog or Humalog for the closed-loop session.
•Willing to refrain from taking acetaminophen products for the duration of the clinical trial.
•Willing to abide by the study protocol and use study-provided devices, including the Omnipod OR Tandem Pump, Dexcom CGM, glucometer, ketone meter and APS APP on the study phone device.

Exclusion Criteria

•Pregnancy
•One or more episodes of hypoglycemia requiring an emergency room visit or hospitalization in the past 6 months.
•One or more episodes of hyperglycemia requiring an emergency room visit or hospitalization in the past 6 months.
•Known unstable cardiac disease or untreated cardiac disease, as revealed by history or physical examination.
•Dermatological conditions that would preclude wearing a CGM sensor or Pod/infusion site.
•One or more seizures in the past year.
•Any condition that could interfere with participating in the trial, based on investigator judgment.
•Participation in another pharmaceutical or device trial at the time of enrollment or during the study.

Outcomes

Primary Outcomes

Percent time in glucose range 70-180 mg/dL

Time Frame: 48 hours

Time in target glucose range overall

Secondary Outcomes

Percent time glucose > 180 mg/dL(48 hours)
Percent time in glucose range 80-140 mg/dL overnight(48 hours)
Percent time in glucose range 70-150 mg/dl postprandial within 5 hours following meals(48 hours)
Percent time glucose > 250 mg/dL(48 Hours)
Percent time glucose < 70 mg/dL(48 hours)
Percent time glucose < 54 mg/dL(48 hours)
Connectivity Analysis (Number of Connection Errors Between devices)(48 Hours)