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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| Harvard University | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AID Evaluation | Experimental | After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated Insulin Delivery | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Postprandial Time in Target Glucose Range |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Sensor Use Time | Percent Time CGM during the clinical trial |
Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Eyal Dassau, PhD | Harvard University John A Paulson School of Engineering and Applied Sciences | Principal Investigator |
| Yogish Kudva, MD | Mayo Clinic | Principal Investigator |
| Carol Levy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Barak Rosenn, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Grenye O'Malley, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Kristin Castorino, DO | Sansum Diabetes Research Institute | Principal Investigator |
| Jordan Pinsker, MD | Sansum Diabetes Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37196353 | Result | 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 Pregnancy Consortium. At-Home Use of a Pregnancy-Specific Zone-MPC Closed-Loop System for Pregnancies Complicated by Type 1 Diabetes: A Single-Arm, Observational Multicenter Study. Diabetes Care. 2023 Jul 1;46(7):1425-1431. doi: 10.2337/dc23-0173. | |
| 35230138 |
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| ID | Title | Description |
|---|---|---|
| FG000 | AID Evaluation | After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Ten participants were enrolled in the study and used the system from their enrollment until delivery of the baby.
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| ID | Title | Description |
|---|---|---|
| BG000 | AID Evaluation | After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | percent time | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
Pregnancy through delivery, up to 40 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AID Evaluation | After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ketosis | Endocrine disorders | SNOMED CT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristin Castorino | Sansum Diabetes Research Institute | 805-682-7638 | info@sansum.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2021 | Jun 21, 2023 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 30, 2022 | Mar 18, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
|
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 |
| Glucose < 63 mg/dL | Percent time CGM glucose < 63 mg/dL | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
| Glucose < 54 mg/dL | Percent time CGM glucose < 54 mg/dL | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
| Glucose > 140 mg/dL | Percent time GGM glucose > 140 mg/dL | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
| Glucose > 180 mg/dL | Percent time GGM glucose > 180 mg/dL | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
| 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 |
| 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 |
| Hyperglycemic Events | Number of episodes with ketones >1 mmol/L | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
| Glucose > 250 mg/dL | Percent time GGM glucose > 250 mg/dL | 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 | 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 | 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 | 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 | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
| Mean CGM Glucose Level | Mean CGM glucose level during AID use | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
| Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
| 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 |
| 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 |
| Maternal Outcomes: Eclampsia | Number of subjects who develop eclampsia during pregnancy | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
| 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 |
| 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 |
| 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 |
| Fetal Outcomes: Large for Gestational Age | Number of infants born large for gestational age | At Delivery |
| 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 |
| 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 |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Result |
| 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. Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm. Diabetes Technol Ther. 2022 Jul;24(7):471-480. doi: 10.1089/dia.2021.0521. Epub 2022 Apr 26. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Glycated Hemoglobin | Mean | Standard Deviation | percentage of glycated hemoglobin |
|
|
|
| Secondary | Overnight Time in Target Glucose Range | Sensor glucose time within the target range of 63-140 mg/dl overnight | Posted | Mean | Standard Deviation | percent time | 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 | Posted | Mean | Standard Deviation | percent time | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Secondary | Glucose < 63 mg/dL | Percent time CGM glucose < 63 mg/dL | Posted | Median | Inter-Quartile Range | percent time | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Secondary | Glucose < 54 mg/dL | Percent time CGM glucose < 54 mg/dL | Posted | Median | Inter-Quartile Range | percent time | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Secondary | Glucose > 140 mg/dL | Percent time GGM glucose > 140 mg/dL | Posted | Mean | Standard Deviation | percent time | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Secondary | Glucose > 180 mg/dL | Percent time GGM glucose > 180 mg/dL | Posted | Median | Inter-Quartile Range | percent time | 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. | Posted | Mean | Standard Deviation | events per week | 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 | Posted | Mean | Standard Deviation | Number of Events | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Secondary | Hyperglycemic Events | Number of episodes with ketones >1 mmol/L | Posted | Mean | Standard Deviation | Number of Events | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Secondary | Glucose > 250 mg/dL | Percent time GGM glucose > 250 mg/dL | Posted | Median | Inter-Quartile Range | percent time | 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 | Posted | Number | Events | 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 | Posted | Number | Events | 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 | Infusion Set Failure | Posted | Number | Events | 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 | Posted | Number | Events | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Secondary | Mean CGM Glucose Level | Mean CGM glucose level during AID use | Posted | Mean | Standard Deviation | mg/dL | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Other Pre-specified | Closed-Loop Active Time | Percent time (hours/day) of closed-loop use during the clinical trial | Posted | Mean | Standard Deviation | percent time | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Other Pre-specified | Sensor Use Time | Percent Time CGM during the clinical trial | Posted | Mean | Standard Deviation | percent time | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Other Pre-specified | Maternal Outcomes: Gestational Hypertension | Number of subjects who develop gestational hypertension during pregnancy | Posted | Count of Participants | Participants | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Other Pre-specified | Maternal Outcomes: Pre-eclampsia | Number of subjects who develop pre-eclampsia during pregnancy | Posted | Count of Participants | Participants | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Other Pre-specified | Maternal Outcomes: Eclampsia | Number of subjects who develop eclampsia during pregnancy | Posted | Count of Participants | Participants | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Other Pre-specified | Maternal Outcomes: Oligo/Polyhydramnios | Number of subjects who develop oligo/polyhydramnios during pregnancy | Posted | Count of Participants | Participants | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Other Pre-specified | Maternal Outcomes: Pre Term Labor | Number of subjects who develop pre term labor during pregnancy | Posted | Count of Participants | Participants | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Other Pre-specified | Maternal Outcomes: Primary Caesarian Section | Number of subjects who underwent primary caesarian section | Posted | Count of Participants | Participants | Duration of iAPS Use During Pregnancy up to 40 weeks of Use |
|
|
|
| Other Pre-specified | Fetal Outcomes: Large for Gestational Age | Number of infants born large for gestational age | Posted | Count of Participants | Participants | At Delivery |
|
|
|
| Other Pre-specified | 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. | No IV glucose was given, all treated with glucose gel. | Posted | Count of Participants | Participants | At delivery and up to 48 hours afterwards |
|
|
|
| Other Pre-specified | Fetal Outcomes: Neonatal Intensive Care Unit Admission | Number of infants who are admitted to the neonatal intensive care unit | Posted | Count of Participants | Participants | At delivery and up to 7 days afterwards |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 6 |
| 10 |
| COVID-19 | Infections and infestations | SNOMED CT | Systematic Assessment |
|
| gestational hypertension | Pregnancy, puerperium and perinatal conditions | SNOMED CT | Systematic Assessment |
|
| exacerbation of pre-pregnancy hypertension | Pregnancy, puerperium and perinatal conditions | SNOMED CT | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |