Safety and Feasibility Evaluation of the APS APP

Completed · Phase 2/Phase 3

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03504046

Run by

Sansum Diabetes Research Institute

People needed

6

Starts

2018-02-28

Expected to finish

2018-09-04

Last updated by the study team

2018-09-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sansum Diabetes Research Institute — Santa Barbara, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.