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

NCT04492566 | Completed Results DMC FDA Device

• 1 other identifier: G200099/S001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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).

Conditions

Type 1 Diabetes; Pregnancy

Keywords

type 1 diabetes; pregnancy; artificial pancreas; automated insulin delivery

Outcome Measures

Primary Outcomes (1)

• Time in Target Glucose Range

  Time in target glucose range 63-140 mg/dL measured by CGM to determine safety and efficacy of the integrated system

  Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Secondary Outcomes (15)

• Overnight Time in Target Glucose Range

  Duration of iAPS Use During Pregnancy up to 40 weeks of Use

• Postprandial Time in Target Glucose Range

  Duration of iAPS Use During Pregnancy up to 40 weeks of Use

• Glucose < 63 mg/dL

  Duration of iAPS Use During Pregnancy up to 40 weeks of Use

• Glucose < 54 mg/dL

  Duration of iAPS Use During Pregnancy up to 40 weeks of Use

• Glucose > 140 mg/dL

  Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Other Outcomes (11)

• Closed-Loop Active Time

  Duration of iAPS Use During Pregnancy up to 40 weeks of Use

• Sensor Use Time

  Duration of iAPS Use During Pregnancy up to 40 weeks of Use

• Maternal Outcomes: Gestational Hypertension

  Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Study Arms (1)

AID Evaluation

EXPERIMENTAL

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.

Device: Automated Insulin Delivery

Interventions

Automated Insulin Delivery 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.

Also known as: Interoperable Artificial Pancreas System (iAPS)

AID Evaluation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• A1C \> 9%
• Abnormal liver or renal function (Transaminase \>2 times the upper limit of normal, creatinine \> 1.5 mg/dL)
• 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

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Mayo Clinic: collaborator
• Harvard University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (3)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (2)

• 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.

  PMID: 37196353 RESULT

• 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.

  PMID: 35230138 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Kristin Castorino
• Organization: Sansum Diabetes Research Institute

info@sansum.org

805-682-7638

Study Officials

• Eyal Dassau, PhD

  Harvard University John A Paulson School of Engineering and Applied Sciences

  PRINCIPAL INVESTIGATOR

• Yogish Kudva, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Carol Levy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Barak Rosenn, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Grenye O'Malley, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Kristin Castorino, DO

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

• Jordan Pinsker, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: July 27, 2020
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: August 4, 2023
• Results First Posted: August 4, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)