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NCT Number: NCT03504046

Safety and Feasibility Evaluation of the APS APP

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Percent time in glucose range 70-180 mg/dL

    Time frame: 48 hours

    Time in target glucose range overall

Secondary outcomes

  1. Percent time in glucose range 80-140 mg/dL overnight

    Time frame: 48 hours

    Overnight time in tight target range

  2. Percent time in glucose range 70-150 mg/dl postprandial within 5 hours following meals

    Time frame: 48 hours

    Post prandial time in target

  3. Percent time glucose < 70 mg/dL

    Time frame: 48 hours

    Hypoglycemia

  4. Percent time glucose < 54 mg/dL

    Time frame: 48 hours

    Significant Hypoglycemia

  5. Percent time glucose > 180 mg/dL

    Time frame: 48 hours

    Hyperglycemia

  6. Percent time glucose > 250 mg/dL

    Time frame: 48 Hours

    Significant Hyperglycemia

  7. Connectivity Analysis (Number of Connection Errors Between devices)

    Time frame: 48 Hours

    Failure analysis of the devices/connectivity issues that may occur. This includes the overall number of connectivity errors between pump, sensor and phone device and the types of errors and how they were addressed.

Sponsors and collaborators

Lead sponsor

Sansum Diabetes Research Institute

Other

Collaborators

  • Harvard University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2018
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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