ClinicalTrials.gov

History of Changes for Study: NCT02748018
Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System at Home
Latest version (submitted July 14, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 21, 2016 None (earliest Version on record)
2 October 14, 2016 Study Status
3 May 3, 2017 Recruitment Status, Study Status, Oversight, Arms and Interventions, IPDSharing and Contacts/Locations
4 May 30, 2017 Outcome Measures, Arms and Interventions, Contacts/Locations, Study Design and Study Status
5 June 6, 2017 Outcome Measures, Arms and Interventions and Study Status
6 June 19, 2017 Contacts/Locations, Eligibility and Study Status
7 September 12, 2017 Contacts/Locations and Study Status
8 September 14, 2017 Contacts/Locations and Study Status
9 November 10, 2017 Contacts/Locations and Study Status
10 December 19, 2017 Study Status
11 February 28, 2018 Eligibility, Contacts/Locations and Study Status
12 May 14, 2018 Contacts/Locations and Study Status
13 July 11, 2018 Study Description, Study Status and Contacts/Locations
14 October 1, 2018 Study Status and Contacts/Locations
15 November 12, 2018 Contacts/Locations and Study Status
16 December 4, 2018 Study Status, Contacts/Locations and Eligibility
17 March 25, 2019 Contacts/Locations and Study Status
18 April 5, 2019 Study Status and Contacts/Locations
19 April 12, 2019 Contacts/Locations and Study Status
20 May 7, 2019 Study Status, Study Identification and Contacts/Locations
21 July 8, 2019 Contacts/Locations and Study Status
22 August 26, 2019 Contacts/Locations and Study Status
23 December 10, 2019 Contacts/Locations and Study Status
24 February 19, 2020 Study Status and Contacts/Locations
25 February 21, 2020 Contacts/Locations and Study Status
26 June 17, 2020 Contacts/Locations and Study Status
27 October 7, 2020 Contacts/Locations and Study Status
28 March 15, 2021 Contacts/Locations and Study Status
29 March 29, 2021 Contacts/Locations and Study Status
30 June 24, 2021 Arms and Interventions, Study Status, Contacts/Locations, Eligibility, Study Design and Study Description
31 September 9, 2021 Study Status and Study Design
32 October 13, 2021 Contacts/Locations and Study Status
33 May 10, 2022 Contacts/Locations and Study Status
34 May 18, 2022 Study Status
35 May 19, 2022 Study Status and Contacts/Locations
36 July 14, 2022 Contacts/Locations and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02748018
Submitted Date:  April 21, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: CEP 304
Brief Title: Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System at Home
Official Title: Multi-center, Randomized, Adaptive, Controlled Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System at Home
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2016
Overall Status: Not yet recruiting
Study Start: June 2016
Primary Completion: August 2020 [Anticipated]
Study Completion: December 2020 [Anticipated]
First Submitted: April 19, 2016
First Submitted that
Met QC Criteria:
April 21, 2016
First Posted: April 22, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 21, 2016
Last Update Posted: April 22, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Medtronic Diabetes
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: 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)
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.

Open or close this module Conditions
Conditions: Type 1 Diabetes
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1500 [Anticipated]
Open or close this module Arms and Interventions
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
No Intervention: 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.
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
Experimental: 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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in A1C (∆A1C)
[ Time Frame: 6 months ]

2. Event rate of severe hypoglycemia
[ Time Frame: 6 months ]

3. Event rate of DKA
[ Time Frame: 6 months ]

Secondary Outcome Measures:
1. Time in Hypoglycemic Range
[ Time Frame: 6 months ]

2. Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L)
[ Time Frame: 6 months ]

Open or close this module Eligibility
Minimum Age: 7 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Thomas Troub
Telephone: (818) 576-3142
Email: thomas.troub@medtronic.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services