Feasibility Evaluation of an Artificial Pancreas With Glucose Prediction Trust Index

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

The purpose of this pilot study is to establish that closed-loop insulin delivery with a target enchanted model predictive control (eMPC)/Health Monitoring System (HMS) algorithms with a trust index of the predicted glucose value is safe and effective, to analyze and learn to improve upon the accuracy of the predicted glucose values, and to collect efficacy data to inform a future larger study.

Key facts

Study ID

NCT03092310

Run by

Sansum Diabetes Research Institute

People needed

15

Starts

2017-03-20

Expected to finish

2017-12-20

Last updated by the study team

2018-07-12

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%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit, or if already completed within 2 months of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
• Serum creatinine of < 2.0 mg/dL. Serum creatinine will be assessed at the screening visit, or if already completed within 2 months of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
• Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate.
• Willing to perform at least 7 fingerstick blood glucose tests a day.
• Willing to refrain from taking acetaminophen products for the duration of the clinical trial. If acetaminophen is taken, subject is to avoid making any insulin dosing decisions based on CGM for at least 12 hours.
• Willing to abide by the study protocol and use study-provided devices, including the Omnipod, Dexcom CGM, glucometer, ketone meter and pAPS tablet.

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.
• One or more seizures in the past year.
• Screening A1c ≥ 10% or serum creatinine ≥ 2.0 mg/dL.
• Any condition that could interfere with participating in the trial, based on investigator judgment.
• Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals), defined as using any of these medications within 30 days of the screening visit or during the study.
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study.

Where it is running

• William Sansum Diabetes Center — Santa Barbara, California, United States

Full record on ClinicalTrials.gov

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