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Safety and Feasibility Evaluation of the APS APP

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ClinicalTrials.gov Identifier: NCT03504046
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
Harvard University
Information provided by (Responsible Party):
Sansum Diabetes Research Institute

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: Artificial Pancreas App Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inpatient Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the APS APP
Actual Study Start Date : February 28, 2018
Actual Primary Completion Date : September 4, 2018
Actual Study Completion Date : September 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Artificial Pancreas App
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
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 Outcome Measures :
  1. Percent time in glucose range 70-180 mg/dL [ Time Frame: 48 hours ]
    Time in target glucose range overall


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504046


Locations
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United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
Sansum Diabetes Research Institute
Harvard University
Investigators
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Principal Investigator: Eyal Dassau, PhD Harvard University
Principal Investigator: Jordan Pinsker, MD Sansum Diabetes Research Institute

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Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT03504046     History of Changes
Other Study ID Numbers: G180011
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Sansum Diabetes Research Institute:
artificial pancreas
hyperglycemia
hypoglycemia

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents