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