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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492566
• Other study ID #: G200099/S001
• Status: Completed
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: October 5, 2022

Study information

• Verified date: July 2023
• Source: Sansum Diabetes Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 5, 2022
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

• 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.

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

• History of severe hypoglycemia in the past 6 months

• History of DKA requiring hospitalization in the past 6 months

• Significant chronic kidney disease (eGFR < 60) or hemodialysis

• Significant liver disease

• History of adrenal insufficiency

• History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated

• History of high dose steroid use in the past 8 weeks

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Pregnancy
• Type 1 Diabetes

Intervention

Device:
• Automated Insulin Delivery
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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Sansum Diabetes Research Institute	Santa Barbara	California

Sponsors (4)

Lead Sponsor	Collaborator
Sansum Diabetes Research Institute	Harvard University, Icahn School of Medicine at Mount Sinai, Mayo Clinic

Country where clinical trial is conducted

United States, 

References & 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 Pre — View Citation

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. Feasibili — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Closed-Loop Active Time	Percent time (hours/day) of closed-loop use during the clinical trial	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Other	Sensor Use Time	Percent Time CGM during the clinical trial	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Other	Maternal Outcomes: Gestational Hypertension	Number of subjects who develop gestational hypertension during pregnancy	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Other	Maternal Outcomes: Pre-eclampsia	Number of subjects who develop pre-eclampsia during pregnancy	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Other	Maternal Outcomes: Eclampsia	Number of subjects who develop eclampsia during pregnancy	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Other	Maternal Outcomes: Oligo/Polyhydramnios	Number of subjects who develop oligo/polyhydramnios during pregnancy	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Other	Maternal Outcomes: Pre Term Labor	Number of subjects who develop pre term labor during pregnancy	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Other	Maternal Outcomes: Primary Caesarian Section	Number of subjects who underwent primary caesarian section	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Other	Fetal Outcomes: Large for Gestational Age	Number of infants born large for gestational age	At Delivery
Other	Fetal Outcomes: Neonatal Hypoglycemia	Number of infants who develop neonatal hypoglycemia. Neonatal hypoglycemia is defined as treatment requiring IV dextrose, treatment of the newborn with glucose gel is also reported, however protocols for use of glucose gel varied by delivery location.	At delivery and up to 48 hours afterwards
Other	Fetal Outcomes: Neonatal Intensive Care Unit Admission	Number of infants who are admitted to the neonatal intensive care unit	At delivery and up to 7 days afterwards
Primary	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	Overnight Time in Target Glucose Range	Sensor glucose time within the target range of 63-140 mg/dl overnight	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Postprandial Time in Target Glucose Range	Sensor glucose time within the target range of 63-140 mg/dl postprandially within 2 hours following meals and 2 hours following meals	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Glucose < 63 mg/dL	Percent time CGM glucose < 63 mg/dL	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Glucose < 54 mg/dL	Percent time CGM glucose < 54 mg/dL	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Glucose > 140 mg/dL	Percent time GGM glucose > 140 mg/dL	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Glucose > 180 mg/dL	Percent time GGM glucose > 180 mg/dL	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Hypoglycemic Events Per Week	Number of hypoglycemic events per week, defined as time <54 mg/dL for 15 consecutive minutes followed by time >70 mg/dL for 15 consecutive minutes.	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Severe Hypoglycemic Events	Number of hypoglycemic events that events that require active assistance of another individual	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Hyperglycemic Events	Number of episodes with ketones >1 mmol/L	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Glucose > 250 mg/dL	Percent time GGM glucose > 250 mg/dL	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Serious Adverse Events (SAE)	The total number of serious adverse events during the clinical trial	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Serious Adverse Device Events (SADE)	The total number of serious adverse events related to the study device use during the clinical trial	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Adverse Device Effects (ADE)	The total number of adverse device effects (ADE) during the clinical trial	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Unanticipated Adverse Device Effects (UADE)	The total number of unanticipated adverse device effects (UADE) during the clinical trial	Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary	Mean CGM Glucose Level	Mean CGM glucose level during AID use	Duration of iAPS Use During Pregnancy up to 40 weeks of Use