Safety and Feasibility Evaluation of the APS APP

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504046
• Other study ID #: G180011
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 28, 2018
• Est. completion date: September 4, 2018

Study information

• Verified date: September 2018
• Source: Sansum Diabetes Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 4, 2018
• Est. primary completion date: September 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Sansum Diabetes Research Institute	Santa Barbara	California

Sponsors (2)

Lead Sponsor	Collaborator
Sansum Diabetes Research Institute	Harvard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent time in glucose range 70-180 mg/dL	Time in target glucose range overall	48 hours
Secondary	Percent time in glucose range 80-140 mg/dL overnight	Overnight time in tight target range	48 hours
Secondary	Percent time in glucose range 70-150 mg/dl postprandial within 5 hours following meals	Post prandial time in target	48 hours
Secondary	Percent time glucose < 70 mg/dL	Hypoglycemia	48 hours
Secondary	Percent time glucose < 54 mg/dL	Significant Hypoglycemia	48 hours
Secondary	Percent time glucose > 180 mg/dL	Hyperglycemia	48 hours
Secondary	Percent time glucose > 250 mg/dL	Significant Hyperglycemia	48 Hours
Secondary	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.	48 Hours