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

  • STATUS
    Recruiting
  • participants needed
    21
  • sponsor
    Sansum Diabetes Research Institute
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Updated on 5 January 2021
See if I qualify
glycosylated hemoglobin
hba1c
hemoglobin a1c
premature birth
type 1 diabetes mellitus
premature rupture of membranes
novolog
humalog
diabetes
type 2 diabetes mellitus
insulin

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).

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.

Details
Condition Diabetes Mellitus, diabetes (pediatric), Insulin dependent diabetes mellitus, Pregnancy, Pregnancy, diabetes (pediatric)
Age 18years - 45years
Treatment Automated Insulin Delivery
Clinical Study IdentifierNCT04492566
SponsorSansum Diabetes Research Institute
Last Modified on5 January 2021

Eligibility

 Yes No Not Sure

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
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
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glycosylated hemoglobin
hba1c
hemoglobin a1c
premature birth
type 1 diabetes mellitus
premature rupture of membranes
novolog
humalog
diabetes
type 2 diabetes mellitus
insulin

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