Safety and Feasibility Evaluation of the APS APP

NCT03504046 | Completed Phase 2 FDA Device

• 1 other identifier: G180011
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

artificial pancreas; hyperglycemia; hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Percent time in glucose range 70-180 mg/dL

  Time in target glucose range overall

  48 hours

Secondary Outcomes (7)

• 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 < 70 mg/dL

  48 hours

• Percent time glucose < 54 mg/dL

  48 hours

• Percent time glucose > 180 mg/dL

  48 hours

Study Arms (1)

Artificial Pancreas App

EXPERIMENTAL

After completing a 1 week open-loop run in period, subjects will use the APS APP for a 48-hour period in an observed transitional environment.

Device: Artificial Pancreas App

Interventions

Artificial Pancreas App DEVICE

The portable Artificial Pancreas System App (APS APP) is an artificial pancreas system comprised primarily of an insulin pump, a continuous glucose monitor (CGM), and a cellular phone device to connect the components.

Artificial Pancreas App

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Harvard University: collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eyal Dassau, PhD

  Harvard University

  PRINCIPAL INVESTIGATOR

• Jordan Pinsker, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 20, 2018
• Study Start: February 28, 2018
• Primary Completion: September 4, 2018
• Study Completion: September 4, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)