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. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Overnight Time in Target Glucose Range
Sensor glucose time within the target range of 63-140 mg/dl overnight
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
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
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose < 63 mg/dL
Percent time CGM glucose \< 63 mg/dL
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose < 54 mg/dL
Percent time CGM glucose \< 54 mg/dL
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose > 140 mg/dL
Percent time GGM glucose \> 140 mg/dL
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose > 180 mg/dL
Percent time GGM glucose \> 180 mg/dL
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Hypoglycemic Events Per Week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Severe Hypoglycemic Events
Number of hypoglycemic events that events that require active assistance of another individual
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Hyperglycemic Events
Number of episodes with ketones \>1 mmol/L
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose > 250 mg/dL
Percent time GGM glucose \> 250 mg/dL
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Serious Adverse Events (SAE)
The total number of serious adverse events during the clinical trial
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Serious Adverse Device Events (SADE)
The total number of serious adverse events related to the study device use during the clinical trial
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Adverse Device Effects (ADE)
The total number of adverse device effects (ADE) during the clinical trial
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Unanticipated Adverse Device Effects (UADE)
The total number of unanticipated adverse device effects (UADE) during the clinical trial
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Mean CGM Glucose Level
Mean CGM glucose level during AID use
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use