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

ID#: NCT04492566

Age: 18 - 45 years

Gender: Female

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: July 27, 2020

End Date: December 15, 2021

Contact Information:
Shelly McCrady-Spitzer
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).

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