Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04492566
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : June 22, 2021
Sponsor:
Collaborators:
Mayo Clinic
Harvard University
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Sansum Diabetes Research Institute

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).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Pregnancy Device: Automated Insulin Delivery Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 27, 2020
Estimated Primary Completion Date : May 15, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

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.

Other Name: Interoperable Artificial Pancreas System (iAPS)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Overnight time in target glucose range [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Sensor glucose time within the target range of 63-140 mg/dl overnight

  2. Postprandial time in target glucose range [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Sensor glucose time within the target range of 63-140 mg/dl postprandially within 2 hours following mealsand 2 hours following meals

  3. Glucose < 63 mg/dL [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Percent time GGM glucose < 63 mg/dL

  4. Glucose < 54 mg/dL [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Percent time GGM glucose < 54 mg/dL

  5. Glucose > 140 mg/dL [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Percent time GGM glucose > 140 mg/dL

  6. Glucose > 180 mg/dL [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Percent time GGM glucose > 180 mg/dL

  7. Hypoglycemic Events [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Number of hypoglycemic events, defined as time <54 mg/dL for 15 consecutive minutes followed by time >70 mg/dL for 15 consecutive minutes.

  8. Severe Hypoglycemic Events [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Number of hypoglycemic events that events that require active assistance of another individual

  9. Hyperglycemic Events [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Number of episodes with ketones >1 mmol/L

  10. Glucose > 250 mg/dL [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Percent time GGM glucose > 250 mg/dL

  11. Serious adverse events (SAE) [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    The total number of serious adverse events during the clinical trial

  12. Serious adverse device events (SADE) [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    The total number of serious adverse events related to the study device use during the clinical trial

  13. Adverse device effects (ADE) [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    The total number of adverse device effects (ADE) during the clinical trial

  14. Unanticipated adverse device effects (UADE) [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    The total number of unanticipated adverse device effects (UADE) during the clinical trial

  15. Mean CGM glucose level [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Mean CGM glucose level during AID use

  16. Number of hypoglycemia treatments [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Number of hypoglycemia treatments given during AID use


Other Outcome Measures:
  1. Closed-Loop Active Time [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Percent time (hours/day) of closed-loop use during the clinical trial

  2. Sensor Use Time [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Total hours of CGM sensor use time during the clinical trial

  3. Device Issues [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Total number of devices issues during the clinical trial

  4. Total daily insulin use [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Total daily insulin use (units/day), compared week to week

  5. Total basal insulin use [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Total daily basal insulin use (units/day) , compared week to week

  6. Total bolus insulin use [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Total daily bolus insulin use (units/day), compared week to week

  7. Maternal outcomes: gestational hypertension [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Number of subjects who develop gestational hypertension during pregnancy

  8. Maternal outcomes: pre-eclampsia [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Number of subjects who develop pre-eclampsia during pregnancy

  9. Maternal outcomes: eclampsia [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Number of subjects who develop eclampsia during pregnancy

  10. Maternal outcomes: oligo/polyhydramnios [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Number of subjects who develop oligo/polyhydramnios during pregnancy

  11. Maternal outcomes: pre term labor [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Number of subjects who develop pre term labor during pregnancy

  12. Maternal outcomes: caesarian section [ Time Frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use ]
    Number of subjects who undergo caesarian section

  13. Fetal Outcomes: Large for gestational age [ Time Frame: At Delivery ]
    Number of infants born large for gestational age

  14. Fetal Outcomes: Neonatal hypoglycemia [ Time Frame: At delivery and up to 48 hours afterwards ]
    Number of infants who develop neonatal hypoglycemia

  15. Fetal Outcomes: Neonatal intensive care unit admission [ Time Frame: At delivery and up to 7 days afterwards ]
    Number of infants who are admitted to the neonatal intensive care unit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492566


Contacts
Layout table for location contacts
Contact: Shelly McCrady-Spitzer 507-255-0316 McCradySpitzer.Shelly@mayo.edu

Locations
Layout table for location information
United States, California
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93105
Contact: Kristin Castorino, N    805-682-7640 ext 256    kcastorino@sansum.org   
Sub-Investigator: Kristin Castorino, DO         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Shelly McCrady-Spitzer    507-255-0316    McCradySpitzer.Shelly@mayo.edu   
Principal Investigator: Yogish Kudva, MBBS         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Camilla M Levister    212-241-5177    camilla.levister@mssm.edu   
Principal Investigator: Carol Levy, MD         
Sponsors and Collaborators
Sansum Diabetes Research Institute
Mayo Clinic
Harvard University
Icahn School of Medicine at Mount Sinai
Investigators
Layout table for investigator information
Principal Investigator: 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT04492566    
Other Study ID Numbers: G200099/S001
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Sansum Diabetes Research Institute:
type 1 diabetes
pregnancy
artificial pancreas
automated insulin delivery
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancrelipase
Gastrointestinal Agents