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Trial record 1 of 1 for:    NCT02748018
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Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System at Home

This study is currently recruiting participants.
Verified November 2017 by Medtronic Diabetes
Sponsor:
ClinicalTrials.gov Identifier:
NCT02748018
First Posted: April 22, 2016
Last Update Posted: November 14, 2017
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.
Information provided by (Responsible Party):
Medtronic Diabetes
  Purpose
The purpose of this study is to demonstrate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A diverse population of patients with type 1 diabetes will be studied. The study population will have a large range for duration of diabetes and glycemic control, as measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)

Condition Intervention
Type 1 Diabetes Device: 670G Insulin Pump Device: Subject's Current Diabetes Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
There will be three cohorts sequentially enrolled for the study. Cohort 1: Continuous Subcutaneous Insulin Infusion (CSII cohort): randomized to HCL (treatment arm) or CSII (Control arm) Cohort 2: Multiple Daily Injections (MDI cohort): randomized to HCL (treatment arm) or MDI (Control arm) Cohort 3: Sensor-Augmented Pump therapy (SAP cohort): randomized to HCL (treatment arm) or SAP (Control arm)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Adaptive, Controlled Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System at Home

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • CSII Cohort: change of A1C (∆A1C) for subjects with baseline A1c > 8% [ Time Frame: 6 months ]
    CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit. This is only for subjects with baseline A1c > 8%

  • CSII Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8% [ Time Frame: 6 months ]
    CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period. This is only for subjects with baseline A1c ≤ 8%

  • MDI Cohort: change of A1C (∆A1C) for subjects with baseline A1c > 8% [ Time Frame: 6 months ]
    MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit. This is only for subjects with baseline A1c > 8%

  • MDI Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8% [ Time Frame: 6 months ]
    MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period. This is only for subjects with baseline A1c ≤ 8%

  • SAP Cohort: change of A1C (∆A1C) for subjects with baseline A1c > 8% [ Time Frame: 6 months ]
    SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit. This is only for subjects with baseline A1c > 8%

  • SAP Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8% [ Time Frame: 6 months ]
    SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period. This is only for subjects with baseline A1c ≤ 8%


Secondary Outcome Measures:
  • CSII Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8% [ Time Frame: 6 months ]
    CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period. This is only for subjects with baseline A1c > 8%

  • CSII Cohort: Change in A1C (∆A1C) for subjects with baseline A1c ≤ 8% [ Time Frame: 6 months ]
    CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit. This is only for subjects with baseline A1c ≤ 8%

  • CSII Cohort: Time in Hypoglycemic Range during Night for all subjects [ Time Frame: 6 months ]
    CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects

  • CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects [ Time Frame: 6 months ]
    CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects

  • CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects [ Time Frame: 6 months ]
    CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects

  • CSII Cohort: Time in Hypoglycemic Range during Day and Night for all subjects [ Time Frame: 6 months ]
    CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects

  • CSII Cohort: Change in A1C for all subjects [ Time Frame: 6 months ]
    CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects

  • MDI Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8% [ Time Frame: 6 months ]
    MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period. This is only for subjects with baseline A1c > 8%

  • MDI Cohort: Change in A1C (∆A1C) for subjects with baseline A1c ≤ 8% [ Time Frame: 6 months ]
    MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit. This is only for subjects with baseline A1c ≤ 8%

  • MDI Cohort: Time in Hypoglycemic Range during Night for all subjects [ Time Frame: 6 months ]
    MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects

  • MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects [ Time Frame: 6 months ]
    MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects

  • MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects [ Time Frame: 6 months ]
    MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects

  • MDI Cohort: Time in Hypoglycemic Range during Day and Night for all subjects [ Time Frame: 6 months ]
    MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects

  • MDI Cohort: Change in A1C for all subjects [ Time Frame: 6 months ]
    MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects

  • SAP Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8% [ Time Frame: 6 months ]
    SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period. This is only for subjects with baseline A1c > 8%

  • SAP Cohort: Change in A1C (∆A1C) for subjects with baseline A1c ≤ 8% [ Time Frame: 6 months ]
    SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit. This is only for subjects with baseline A1c ≤ 8%

  • SAP Cohort: Time in Hypoglycemic Range during Night for all subjects [ Time Frame: 6 months ]
    SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects

  • SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects [ Time Frame: 6 months ]
    SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects

  • SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects [ Time Frame: 6 months ]
    SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects

  • SAP Cohort: Time in Hypoglycemic Range during Day and Night for all subjects [ Time Frame: 6 months ]
    SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects

  • SAP Cohort: Change in A1C for all subjects [ Time Frame: 6 months ]
    SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects


Estimated Enrollment: 1500
Actual Study Start Date: May 25, 2017
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hybrid Closed Loop Arm
The HCL Arm will use the 670G insulin pump and the fourth generation glucose sensor (i.e. using the Auto Mode feature) for 6 months during the study period.
Device: 670G Insulin Pump
Medtronic 670G Hybrid Closed Loop (HCL) ambulatory insulin pump system
Active Comparator: Control Arm
The Control Arm will use individual subject's current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump). Each cohort (CSII, MDI, or SAP) will be used as the control arm to be compared to the experimental arm (HCL).
Device: Subject's Current Diabetes Therapy
Subject will use current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump).

Detailed Description:

This is a 6 month, multi-center, randomized, parallel, adaptive study in type 1 diabetes with a 6 month continuation period. The study will have three periods:

  1. Run-in Period: The run-in period can be up to 60 days during which time a blinded CGM sensor will be worn for two weeks.
  2. Study Period: There will be a 6 month randomized study period with two arms: The HCL system and Control.
  3. Continuation Period: There will be a 6 month continuation period during which time all subjects will use the HCL system with Auto Mode.

Up to 1500 subjects will be enrolled in order to have 1000 subjects complete the study. Up to 70 investigational Centers in the US and Canada, as well as in the Medtronic EMEA region, that is comprised of Europe, the Middle East and Africa, will be enrolled.

  Eligibility

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.


Ages Eligible for Study:   7 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is age 2-80 years at time of screening

    a. Subjects 2-6 years of age will be allowed to enroll in the post approval study, once DMC has reviewed data from 10 subjects age 2-4 years who have completed participation in the study period of the CEP302 study and has given approval to enroll

  2. Subjects who are 2-21 years are determined by the investigator to have the appropriate, requisite support (family, caregiver or social network) to successfully participate in this study
  3. Subject must have a minimum daily insulin requirement (Total Daily Dose) of equal to or greater than 8 units/day
  4. Subjects who are determined by the investigator to be psychologically sound in order to successfully participate in this study
  5. Subject has been diagnosed with type 1 diabetes for at least three months Note: Determination of classification for diabetes will be based on American Diabetes Association Clinical Practice Guidelines accounting for several patient characteristics such as: age of onset, patient's weight or BMI, history of diabetic ketoacidosis, history of therapy management, and medical records if available.
  6. Subject must be on one of the following management therapies:

    • Multiple daily injections defined by use of rapid analogue with meals and long acting analogue (i.e. detemir or glargine), without CGM
    • Insulin pump therapy with or without CGM
  7. Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
  8. Subject is willing to perform required study procedure
  9. Subject is willing to wear the system continuously throughout the study for at least 80% of the time.
  10. Subject is willing to upload data at least weekly from the study pump/meter, must have Internet access and a computer system that meets the requirements for uploading the study pump/meter for data collection
  11. Subject must be willing to use the study glucose meter system (i.e. along with study meter strips). This includes stopping alternative glucose meter systems (such as Freestyle Libre)
  12. If subject has celiac disease, it has been adequately treated as determined by the investigator
  13. Subject with the diagnosis of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease, within 1 year of screening, will be included in the study with the consent of the subject's cardiologist
  14. Subject is willing to take one of the following insulins and can financially afford to use either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount) b. Humalog® (insulin lispro injection) c. NovoLog® (insulin aspart)

Exclusion Criteria:

  1. Subject is on MDI with concurrent CGM therapy for at least 3 months prior to Screening
  2. Subject participated in any Closed Loop study in the past.
  3. Subject is unable to tolerate tape adhesive in the area of sensor placement
  4. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection) or area of infusion set placement
  5. Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
  6. Subject is being treated for hyperthyroidism at time of screening
  7. Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit
  8. Subject has taken any oral, injectable, or IV glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study. (Subjects may be rescreened after 1 month if they fail this exclusion criteria)
  9. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks
  10. Subject is currently abusing illicit drugs or marijuana
  11. Subject is currently abusing prescription drugs
  12. Subject is currently abusing alcohol
  13. Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas at time of screening
  14. Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
  15. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
  16. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
  17. Subject diagnosed with current moderate to severe eating disorder such as anorexia or bulimia
  18. Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia
  19. Subjects who are currently being actively treated for cancer.
  20. Subject who is designated as a research staff member for this study
  Contacts and Locations
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): NCT02748018


Contacts
Contact: Thomas Troub (818) 576-3142 thomas.troub@medtronic.com

Locations
United States, California
SoCal Diabetes Recruiting
Torrance, California, United States, 90505
Contact: Mary Halvorson    310-962-1808    halvorson@socaldiabetes.com   
Principal Investigator: Kevin Kaiserman, MD         
Diablo Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Contact: Ava Paulazzo    925-930-7267    apaulazzo@diabloclinical.com   
Principal Investigator: Mark Christiansen, MD         
United States, Colorado
Barbara Davis Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Christie Beatson    303-724-6761    Christie.Beatson@ucdenver.edu   
Principal Investigator: Satish Garg, MD         
Barbara Davis Center Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Maninder Sethi    303-724-6773    Maninderpal.Sethi@ucdenver.edu   
Principal Investigator: Robert Slover, MD         
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
Contact    404-355-4393      
Principal Investigator: Bruce Bode, MD         
Endocrine Research Solutions Recruiting
Roswell, Georgia, United States, 30076
Contact: Jessica Tapia    678-878-4750    jessiet62@gmail.com   
Principal Investigator: John Reed, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cindy Plunkett, RN    734-936-8065    cplunket@med.umich.edu   
Principal Investigator: Rodica Pop-Busui, MD         
Grunberger Diabetes Institute Recruiting
Bloomfield Hills, Michigan, United States, 48302
Contact: Linda Aman    248-335-7740    laman@gdi-pc.com   
Principal Investigator: George Grunberger, MD         
United States, Minnesota
Initernational Diabetes Center Recruiting
Minneapolis, Minnesota, United States, 55416
Contact: Christine McNaughton    952-993-3545    christine.mcnaughton@parknicollet.com   
Principal Investigator: Amy Criego, MD         
International Diabetes Center Recruiting
Minneapolis, Minnesota, United States, 55416
Contact: Christine Mc Naughton    952-993-3545    christine.mcnaughton@parknicollet.com   
Principal Investigator: Anders Carlson, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Shelly McCrady-Spitzer       McCradySpitzer.Shelly@mayo.edu   
Principal Investigator: Yogish Kudva, MD         
United States, Texas
Texas Diabetes & Endocrinology Recruiting
Austin, Texas, United States, 78731
Contact: Alison Cooper    512-334-3505    acooper@texasdiabetes.com   
Contact: Janikka White    512.334.3505    jwhite@texasdiabetes.com   
Principal Investigator: Luis Casaubon, MD         
United States, Washington
Rainier Clinical Research Recruiting
Renton, Washington, United States, 98057
Contact: Kristen Hughes    425-251-1720    khughes@rainier-research.com   
Principal Investigator: Ronald Brazg, MD         
University of Washington Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Andrea Toulouse    206-598-1262    aet26@uw.edu   
Principal Investigator: Irl Hirsch, MD         
Sponsors and Collaborators
Medtronic Diabetes
  More Information

Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02748018     History of Changes
Other Study ID Numbers: CEP 304
First Submitted: April 19, 2016
First Posted: April 22, 2016
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs