Supervised Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the iAPS in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home

Sansum Diabetes Research Institute3 sites in 1 country10 target enrollmentJuly 27, 2020

ConditionsType 1 Diabetes Pregnancy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Sansum Diabetes Research Institute
Enrollment: 10
Locations: 3
Primary Endpoint: Time in Target Glucose Range
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 27, 2020

End Date

October 5, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Sansum Diabetes Research Institute

Responsible Party

Sponsor

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.

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:
•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.

Outcomes

Primary Outcomes

Time in Target Glucose Range

Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

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

Secondary Outcomes

Glucose > 180 mg/dL(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 > 140 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)
Hypoglycemic Events Per Week(Duration of iAPS Use During Pregnancy up to 40 weeks of Use)
Overnight Time in Target Glucose Range(Duration of iAPS Use During Pregnancy up to 40 weeks of Use)
Hyperglycemic Events(Duration of iAPS Use During Pregnancy up to 40 weeks of Use)
Serious Adverse Events (SAE)(Duration of iAPS Use During Pregnancy up to 40 weeks of Use)
Adverse Device Effects (ADE)(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)
Severe Hypoglycemic Events(Duration of iAPS Use During Pregnancy up to 40 weeks of Use)
Glucose > 250 mg/dL(Duration of iAPS Use During Pregnancy up to 40 weeks of Use)
Serious Adverse Device Events (SADE)(Duration of iAPS Use During Pregnancy up to 40 weeks of Use)
Unanticipated Adverse Device Effects (UADE)(Duration of iAPS Use During Pregnancy up to 40 weeks of Use)
Mean CGM Glucose Level(Duration of iAPS Use During Pregnancy up to 40 weeks of Use)