Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home

NCT ID: NCT04492566

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-27
• Study Completion Date: 2022-10-05

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.

For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Conditions

Type 1 Diabetes; Pregnancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AID Evaluation

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.

For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Group Type: EXPERIMENTAL

Automated Insulin Delivery

Intervention Type: DEVICE

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

For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Interventions

Automated Insulin Delivery

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

For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Intervention Type: DEVICE

Other Intervention Names

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.
• Have a care partner with the following responsibilities: knowing subject whereabouts and being promptly available for contact by study staff during the day and night, residing in the same dwelling as subject during the night, being agreeable to all device training during the supervised HCL session and additional training on hyper- and hypoglycemia treatment, and assisting with emergency care if needed, such as transportation to the hospital or emergency department.

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
• History of severe hypoglycemia in the past 6 months
• History of DKA requiring hospitalization in the past 6 months
• Significant chronic kidney disease (eGFR < 60) or hemodialysis
• Significant liver disease
• History of adrenal insufficiency
• History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
• History of high dose steroid use in the past 8 weeks

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Sansum Diabetes Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eyal Dassau, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard University John A Paulson School of Engineering and Applied Sciences

Yogish Kudva, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Carol Levy, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Barak Rosenn, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Grenye O'Malley, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Kristin Castorino, DO

Role: PRINCIPAL_INVESTIGATOR

Sansum Diabetes Research Institute

Jordan Pinsker, MD

Role: PRINCIPAL_INVESTIGATOR

Sansum Diabetes Research Institute

Locations

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Mayo Clinic

Rochester, Minnesota, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

Levy CJ, Kudva YC, Ozaslan B, Castorino K, O'Malley G, Kaur RJ, Levister CM, Church MM, Desjardins D, McCrady-Spitzer S, Ogyaadu S, Trinidad MC, Reid C, Rizvi S, Deshpande S, Zaniletti I, Kremers WK, Pinsker JE, Doyle FJ, Dassau E; LOIS-P Diabetes and Pregnancy Consortium. At-Home Use of a Pregnancy-Specific Zone-MPC Closed-Loop System for Pregnancies Complicated by Type 1 Diabetes: A Single-Arm, Observational Multicenter Study. Diabetes Care. 2023 Jul 1;46(7):1425-1431. doi: 10.2337/dc23-0173.

Reference Type: RESULT

PMID: 37196353 (View on PubMed)

Ozaslan B, Levy CJ, Kudva YC, Pinsker JE, O'Malley G, Kaur RJ, Castorino K, Levister C, Trinidad MC, Desjardins D, Church MM, Plesser M, McCrady-Spitzer S, Ogyaadu S, Nelson K, Reid C, Deshpande S, Kremers WK, Doyle FJ , III, Rosenn B, Dassau E. Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm. Diabetes Technol Ther. 2022 Jul;24(7):471-480. doi: 10.1089/dia.2021.0521. Epub 2022 Apr 26.

Reference Type: RESULT

PMID: 35230138 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

G200099/S001

Identifier Type: -

Identifier Source: org_study_id