Supervised Safety and Feasibility Evaluation of Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes

Supervised Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the iAPS in Pregnant Patients With Type 1 Diabetes

Sponsors

Lead Sponsor: Sansum Diabetes Research Institute

Collaborator: Mayo Clinic
Harvard University
Icahn School of Medicine at Mount Sinai

Source Sansum Diabetes Research Institute
Brief Summary

This clinical trial is a safety and feasibility study to assess the performance of an artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the iAPS platform for pregnant patients with type 1 diabetes (T1D).

Detailed Description

The system will be evaluated on up to 21 pregnant adult subjects with type 1 diabetes age 18-45 years old at three clinical sites (Sansum Diabetes Research Institute, Mayo Clinic Rochester MN and Mt Sinai Hospital, New York City). Subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. During the session, subjects will bolus for all meals and snacks, and will perform their usual daily activities while being accompanied by study medical staff.

Overall Status Recruiting
Start Date July 27, 2020
Completion Date December 15, 2021
Primary Completion Date June 15, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Time in target glucose range 48 hours
Secondary Outcome
Measure Time Frame
Overnight time in target glucose range 48 hours
Postprandial time in target glucose range 2 hours
Glucose < 63 mg/dL 48 hours
Glucose < 54 mg/dL 48 hours
Glucose > 140 mg/dL 48 hours
Glucose > 180 mg/dL 48 hours
Glucose > 250 mg/dL 48 hours
Serious adverse events (SAE) 48 hours
Serious adverse device events (SADE) 48 hours
Adverse device effects (ADE) 48 hours
Unanticipated adverse device effects (UADE) 48 hours
Mean CGM glucose level 48 hours
Number of hypoglycemia treatments 48 hours
Enrollment 21
Condition
Intervention

Intervention Type: Device

Intervention Name: Automated Insulin Delivery

Description: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.

Arm Group Label: AID Evaluation

Other Name: Interoperable Artificial Pancreas System (iAPS)

Eligibility

Criteria:

Inclusion Criteria: - Age ≥ 18 and ≤ 45 years at the time of screening. - Clinical diagnosis of type 1 diabetes - Currently using an insulin pump at the time of screening. - HbA1c ≤ 9%, as performed by point of care or central laboratory testing. - Pregnant 14+0/7 to 32+6/7 weeks gestation. - Singleton pregnancy without any other significant known complications, such as preeclampsia, premature rupture of membranes, 2nd/3rd trimester bleeding, fetal growth or fluid abnormalities. - No proven or suspected fetal malformations diagnosed in the current pregnancy. - Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate. - Willing to switch to, or continue Novolog or Humalog for the closed-loop session. - Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial. - Willing to abide by the study protocol and use study-provided devices. Exclusion Criteria: - Known unstable cardiac disease or untreated cardiac disease, as revealed by history or physical examination. - Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas). - Hemophilia or any other bleeding disorder - Prior history of Preterm Premature Rupture of Membranes (PPROM) - Significant hyperemesis interfering with carbohydrate intake - Laboratory results: 1. A1C > 9% 2. Abnormal liver or renal function (Transaminase >2 times the upper limit of normal, creatinine > 1.5 mg/dL) 3. Liver and renal function testing drawn at screening visit or within three months prior to screening (for other purposes) will suffice for enrollment purposes - Dermatological conditions that would preclude wearing a CGM sensor or infusion site. - 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. - Having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

Gender: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Shelly McCrady-Spitzer

Phone: 507-255-0316

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Sansum Diabetes Research Institute | Santa Barbara, California, 93105, United States Recruiting Jordan Pinsker, MD 805-682-7640 257 [email protected] Jordan E Pinsker, MD Principal Investigator
Mayo Clinic | Rochester, Minnesota, 55905, United States Recruiting Shelly McCrady-Spitzer 507-255-0316 [email protected] Yogish Kudva, MBBS Principal Investigator
Icahn School of Medicine at Mount Sinai | New York, New York, 10029, United States Recruiting Camilla M Levister 212-241-5177 [email protected] Carol Levy, MD Principal Investigator
Location Countries

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: AID Evaluation

Type: Experimental

Description: After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov