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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. (see Contacts and Locations)
Verified May 2017 by Medtronic Diabetes
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT02748018
First received: April 19, 2016
Last updated: May 3, 2017
Last verified: May 2017
  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 Phase
Type 1 Diabetes
Device: 670G Insulin Pump
Device: Fourth Generation Glucose Sensor system
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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:
  • Change in A1C (∆A1C) [ Time Frame: 6 months ]
  • Event rate of severe hypoglycemia [ Time Frame: 6 months ]
  • Event rate of DKA [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Time in Hypoglycemic Range [ Time Frame: 6 months ]
  • Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) [ Time Frame: 6 months ]

Estimated Enrollment: 1500
Anticipated Study Start Date: May 22, 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 system and the fourth generation glucose sensor (i.e. using the Auto Mode feature) for 6 months during the study period.
Device: 670G Insulin Pump
Investigational use of the Medtronic 670G insulin pump
Device: Fourth Generation Glucose Sensor system
Investigational use of the Medtronic Fourth Generation Glucose Sensor system
Active Comparator: The Multiple Daily Injection (MDI)
The Multiple Daily Injection (MDI) group will remain on MDI therapy with subjects using their own insulin for 6 months during the study period.
Device: Fourth Generation Glucose Sensor system
Investigational use of the Medtronic Fourth Generation Glucose Sensor system
Active Comparator: Continuous Subcutaneous Insulin Infusion (CSII)
The CSII group will use the 670G pump without Real Time CGM (glucose sensor) during the 6 month study period.
Device: 670G Insulin Pump
Investigational use of the Medtronic 670G insulin pump
Active Comparator: Sensor Augmented Pump (SAP)
The Sensor Augmented Pump (SAP) group will use the 670G pump (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode) with Real Time CGM (glucose sensor) for the 6 month study period.
Device: 670G Insulin Pump
Investigational use of the Medtronic 670G insulin pump
Device: Fourth Generation Glucose Sensor system
Investigational use of the Medtronic Fourth Generation Glucose Sensor system

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

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 7-75 years at time of screening
  2. Subjects who are 7-21 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 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 sensor calibrations
  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, must have Internet access and a computer system that meets the requirements for uploading the study pump
  11. Subject must be able to speak and be literate in English
  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)

    1. Humalog® (insulin lispro injection)
    2. 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 upper reference range, as processed by Central Lab) in creatinine at time of screening visit
  8. Subject has an abnormality (out of reference range, as processed by Central Lab) in thyroid-stimulating hormone (TSH) at time of screening visit
  9. Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study. (Subjects may be rescreened after 1 month if they fail this exclusion criteria)
  10. 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
  11. Subject has been hospitalized or has visited the emergency room in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes (i.e. diabetic ketoacidosis [DKA]) except if this is related to a new diagnosis.
  12. Subject is currently abusing illicit drugs or marijuana
  13. Subject is currently abusing prescription drugs
  14. Subject is currently abusing alcohol
  15. Subject is using pramlintide (Symlin) SGLT2 inhibitor, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas at time of screening
  16. 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
  17. Subject has elective surgery planned that requires general anesthesia during the course of the study
  18. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
  19. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
  20. Subject diagnosed with current eating disorder such as anorexia or bulimia
  21. Subject has been diagnosed with chronic kidney disease that results in chronic anemia
  22. Subjects who are currently being treated for cancer or plan to be treated for cancer.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02748018

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

Locations
United States, Washington
Rainier Clinical Rsearch Recruiting
Renton, Washington, United States, 98057
Contact: Kristen Hughes    425-251-1720    kmhghes@rainier-research.com   
Principal Investigator: Ronald Brazg, 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
Study First Received: April 19, 2016
Last Updated: May 3, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on May 23, 2017