Clinical trial NCT03504046: Safety and Feasibility Evaluation of the APS APP
Official title: Inpatient Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the APS APP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 1 Diabetes Mellitus
Keywords: artificial pancreas
hyperglycemia
hypoglycemia
Lead sponsor: Sansum Diabetes Research Institute
Sponsor class: OTHER
Collaborators: name: Harvard University
First posted: 2018-04-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Percent time in glucose range 70-180 mg/dL
timeFrame: 48 hours
Secondary outcomes:
measure: Percent time in glucose range 80-140 mg/dL overnight
timeFrame: 48 hours
measure: Percent time in glucose range 70-150 mg/dl postprandial within 5 hours following meals
timeFrame: 48 hours
measure: Percent time glucose < 70 mg/dL
timeFrame: 48 hours
measure: Percent time glucose < 54 mg/dL
timeFrame: 48 hours
measure: Percent time glucose > 180 mg/dL
timeFrame: 48 hours
measure: Percent time glucose > 250 mg/dL
timeFrame: 48 Hours
measure: Connectivity Analysis (Number of Connection Errors Between devices)
timeFrame: 48 Hours
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
Study officials:
affiliation: Harvard University
name: Eyal Dassau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sansum Diabetes Research Institute
name: Jordan Pinsker, MD
role: PRINCIPAL_INVESTIGATOR
References: