Type 1 Diabetes Mellitus
Conditions
Keywords
artificial pancreas, hyperglycemia, hypoglycemia
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).
Interventions
DEVICEArtificial 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.
Sponsors
Harvard University
Sansum Diabetes Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent time in glucose range 70-180 mg/dL | 48 hours | Time in target glucose range overall |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent time in glucose range 70-150 mg/dl postprandial within 5 hours following meals | 48 hours | Post prandial time in target |
| Percent time glucose < 70 mg/dL | 48 hours | Hypoglycemia |
| Percent time glucose < 54 mg/dL | 48 hours | Significant Hypoglycemia |
| Percent time in glucose range 80-140 mg/dL overnight | 48 hours | Overnight time in tight target range |
| Percent time glucose > 250 mg/dL | 48 Hours | Significant Hyperglycemia |
| Connectivity Analysis (Number of Connection Errors Between devices) | 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. |
| Percent time glucose > 180 mg/dL | 48 hours | Hyperglycemia |
Countries
United States
Outcome results
None listed