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Supervised Safety and Feasibility Evaluation of Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes

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 : September 29, 2020
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.

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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
Actual Study Start Date : July 27, 2020
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.
Device: Automated Insulin Delivery
Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.
Other Name: Interoperable Artificial Pancreas System (iAPS)




Primary Outcome Measures :
  1. Time in target glucose range [ Time Frame: 48 hours ]
    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: 48 hours ]
    Sensor glucose time within the target range of 63-140 mg/dl overnight

  2. Postprandial time in target glucose range [ Time Frame: 2 hours ]
    Sensor glucose time within the target range of 63-140 mg/dl postprandially 1 and 2 hours following meals

  3. Glucose < 63 mg/dL [ Time Frame: 48 hours ]
    Percent time GGM glucose < 63 mg/dL

  4. Glucose < 54 mg/dL [ Time Frame: 48 hours ]
    Percent time GGM glucose < 54 mg/dL

  5. Glucose > 140 mg/dL [ Time Frame: 48 hours ]
    Percent time GGM glucose > 140 mg/dL

  6. Glucose > 180 mg/dL [ Time Frame: 48 hours ]
    Percent time GGM glucose > 180 mg/dL

  7. Glucose > 250 mg/dL [ Time Frame: 48 hours ]
    Percent time GGM glucose > 250 mg/dL

  8. Serious adverse events (SAE) [ Time Frame: 48 hours ]
    The total number of serious adverse events during the clinical trial

  9. Serious adverse device events (SADE) [ Time Frame: 48 hours ]
    The total number of serious adverse events related to the study device use during the clinical trial

  10. Adverse device effects (ADE) [ Time Frame: 48 hours ]
    The total number of adverse device effects (ADE) during the clinical trial

  11. Unanticipated adverse device effects (UADE) [ Time Frame: 48 hours ]
    The total number of unanticipated adverse device effects (UADE) during the clinical trial

  12. Mean CGM glucose level [ Time Frame: 48 hours ]
    Mean CGM glucose level during AID use

  13. Number of hypoglycemia treatments [ Time Frame: 48 hours ]
    Number of hypoglycemia treatments given during AID use


Other Outcome Measures:
  1. Closed-Loop Active Time [ Time Frame: 48 hours ]
    Percent time (hours/day) of closed-loop use during the clinical trial

  2. Sensor Use Time [ Time Frame: 48 hours ]
    Total hours of CGM sensor use time during the clinical trial

  3. Device Issues [ Time Frame: 48 hours ]
    Total number of devices issues during the clinical trial

  4. Total daily insulin use [ Time Frame: 48 hours ]
    Total number of devices issues during the clinical trial

  5. Total basal insulin use [ Time Frame: 48 hours ]
    Total daily basal insulin use (units/day) during the clinical trial

  6. Total bolus insulin use [ Time Frame: 48 hours ]
    Total daily bolus insulin use (units/day) during the clinical trial



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.


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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.

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

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
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Contact: Shelly McCrady-Spitzer 507-255-0316 McCradySpitzer.Shelly@mayo.edu

Locations
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United States, California
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93105
Contact: Jordan Pinsker, MD    805-682-7640 ext 257    jpinsker@sansum.org   
Principal Investigator: Jordan E Pinsker, MD         
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
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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
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Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT04492566    
Other Study ID Numbers: G200099
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancrelipase
Gastrointestinal Agents