Safety and Feasibility Evaluation of the APS APP
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Artificial Pancreas App
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring artificial pancreas, hyperglycemia, hypoglycemia
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.
Sites / Locations
- Sansum Diabetes Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Artificial Pancreas App
Arm Description
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.
Outcomes
Primary Outcome Measures
Percent time in glucose range 70-180 mg/dL
Time in target glucose range overall
Secondary Outcome Measures
Percent time in glucose range 80-140 mg/dL overnight
Overnight time in tight target range
Percent time in glucose range 70-150 mg/dl postprandial within 5 hours following meals
Post prandial time in target
Percent time glucose < 70 mg/dL
Hypoglycemia
Percent time glucose < 54 mg/dL
Significant Hypoglycemia
Percent time glucose > 180 mg/dL
Hyperglycemia
Percent time glucose > 250 mg/dL
Significant Hyperglycemia
Connectivity Analysis (Number of Connection Errors Between devices)
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.
Full Information
NCT ID
NCT03504046
First Posted
April 5, 2018
Last Updated
September 4, 2018
Sponsor
Sansum Diabetes Research Institute
Collaborators
Harvard University
1. Study Identification
Unique Protocol Identification Number
NCT03504046
Brief Title
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
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
September 4, 2018 (Actual)
Study Completion Date
September 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sansum Diabetes Research Institute
Collaborators
Harvard University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
artificial pancreas, hyperglycemia, hypoglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Artificial Pancreas App
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Artificial Pancreas App
Intervention Description
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 Measure Information:
Title
Percent time in glucose range 70-180 mg/dL
Description
Time in target glucose range overall
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Percent time in glucose range 80-140 mg/dL overnight
Description
Overnight time in tight target range
Time Frame
48 hours
Title
Percent time in glucose range 70-150 mg/dl postprandial within 5 hours following meals
Description
Post prandial time in target
Time Frame
48 hours
Title
Percent time glucose < 70 mg/dL
Description
Hypoglycemia
Time Frame
48 hours
Title
Percent time glucose < 54 mg/dL
Description
Significant Hypoglycemia
Time Frame
48 hours
Title
Percent time glucose > 180 mg/dL
Description
Hyperglycemia
Time Frame
48 hours
Title
Percent time glucose > 250 mg/dL
Description
Significant Hyperglycemia
Time Frame
48 Hours
Title
Connectivity Analysis (Number of Connection Errors Between devices)
Description
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.
Time Frame
48 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Dassau, PhD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jordan Pinsker, MD
Organizational Affiliation
Sansum Diabetes Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sansum Diabetes Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Feasibility Evaluation of the APS APP
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