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Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
670G and 770G Insulin Pump
Subject's Current Diabetes Therapy
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

2 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

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

    1. US, Canada, Australia and New Zealand: Subjects 2-80 years of age will be allowed to enroll in the post approval study.
    2. Europe: Only subjects ≥7 years of age are allowed to enroll in the post-market study.
  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, if available in the medical records.
  6. Subject must be on one of the following management therapies:

    1. Multiple daily injections defined by use of rapid analogue with meals and approved long acting analogue (e.g. detemir or glargine) with or without CGM
    2. 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 procedures
  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).
  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 Investigator
  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 participated in any Closed Loop study in the past.
  2. Subject is unable to tolerate tape adhesive in the area of sensor placement
  3. 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
  4. Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
  5. Subject is being treated for hyperthyroidism at time of screening
  6. Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit. TSH is not required for subjects 2-13 years of age.
  7. 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.
  8. 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
  9. Subject is currently abusing illicit drugs or marijuana
  10. Subject is currently abusing prescription drugs
  11. Subject is currently abusing alcohol
  12. Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas at time of screening
  13. Subject is using hydroxyurea at the time of screening or plans to use it during the study
  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

Sites / Locations

  • Scripps Health System
  • Stanford University
  • Center of Excellence in Diabetes & Endocrinology
  • Sansum Diabetes Research Institute
  • SoCal Diabetes
  • Diablo Clinical Research
  • Barbara Davis Center
  • Yale School of Medicine
  • University of South Florida Diabetes CenterRecruiting
  • Atlanta Diabetes Associates
  • Endocrine Research Solutions
  • Rocky Mountain DiabetesRecruiting
  • Indiana University Health Riley Hospital for Children
  • IDERCRecruiting
  • University of Michigan
  • Grunberger Diabetes Institute
  • Initernational Diabetes Center
  • International Diabetes Center
  • Mayo Clinic
  • Washington University St. Louis
  • SUNY Upstate Medical University
  • Sanford Health
  • Texas Diabetes & Endocrinology
  • Texas Children's Hospital / Baylor University
  • Diabetes and Glandular Disease Clinic, P.A.Recruiting
  • Rainier Clinical Research
  • University of Washington
  • Westminster Endocrine & Diabetes Research Society
  • Children's Hospital of Eastern Ontario
  • Hôpital Necker Enfants Malades
  • HCL - Lyon Sud
  • Diabeteszentrum für Kinder und Jugendliche, Kinder- und Jugendkrankenhaus Auf der Bult
  • A.S.S.T. Spedali Civili
  • New Zealand Clinical ResearchRecruiting
  • Dunedin Public HospitalRecruiting
  • Hospital Universitario Virgen del Rocío
  • Dept Internal Medicine, Örebro University Hospital
  • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hybrid Closed Loop Arm

Control Arm

Arm Description

The HCL Arm will use the MiniMed System (i.e., using Auto Mode) for 6 months during the study period.

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).

Outcomes

Primary Outcome Measures

CSII Cohort: change of A1C (∆A1C) for subjects with baseline A1c > 8%
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%
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%
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%
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%
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%
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%
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%
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
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
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
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
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
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%
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%
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
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
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
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
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
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%
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%
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
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
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
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
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
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

Full Information

First Posted
April 19, 2016
Last Updated
September 14, 2023
Sponsor
Medtronic Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT02748018
Brief Title
Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home
Official Title
Multi-center, Randomized, Parallel, Adaptive, Controlled Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control (CSII, MDI and SAP) at Home
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2017 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate 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, per Cohort: 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. Study Period: There will be a 6 month randomized study period with two arms: The HCL system and Control. 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, Europe, Canada, Australia and New Zealand will be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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) Note: Subjects 2-6 years of age will automatically enter the HCL arm at the end of the run-in period
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hybrid Closed Loop Arm
Arm Type
Experimental
Arm Description
The HCL Arm will use the MiniMed System (i.e., using Auto Mode) for 6 months during the study period.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
670G and 770G Insulin Pump
Intervention Description
Medtronic 670G and 770G Hybrid Closed Loop Systems
Intervention Type
Device
Intervention Name(s)
Subject's Current Diabetes Therapy
Intervention Description
Subject will use current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump).
Primary Outcome Measure Information:
Title
CSII Cohort: change of A1C (∆A1C) for subjects with baseline A1c > 8%
Description
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%
Time Frame
6 months
Title
CSII Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8%
Description
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%
Time Frame
6 months
Title
MDI Cohort: change of A1C (∆A1C) for subjects with baseline A1c > 8%
Description
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%
Time Frame
6 months
Title
MDI Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8%
Description
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%
Time Frame
6 months
Title
SAP Cohort: change of A1C (∆A1C) for subjects with baseline A1c > 8%
Description
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%
Time Frame
6 months
Title
SAP Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8%
Description
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%
Time Frame
6 months
Secondary Outcome Measure Information:
Title
CSII Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8%
Description
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%
Time Frame
6 months
Title
CSII Cohort: Change in A1C (∆A1C) for subjects with baseline A1c ≤ 8%
Description
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%
Time Frame
6 months
Title
CSII Cohort: Time in Hypoglycemic Range during Night for all subjects
Description
CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
Time Frame
6 months
Title
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Description
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
Time Frame
6 months
Title
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Description
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
Time Frame
6 months
Title
CSII Cohort: Time in Hypoglycemic Range during Day and Night for all subjects
Description
CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
Time Frame
6 months
Title
CSII Cohort: Change in A1C for all subjects
Description
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
Time Frame
6 months
Title
MDI Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8%
Description
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%
Time Frame
6 months
Title
MDI Cohort: Change in A1C (∆A1C) for subjects with baseline A1c ≤ 8%
Description
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%
Time Frame
6 months
Title
MDI Cohort: Time in Hypoglycemic Range during Night for all subjects
Description
MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
Time Frame
6 months
Title
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Description
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
Time Frame
6 months
Title
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Description
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
Time Frame
6 months
Title
MDI Cohort: Time in Hypoglycemic Range during Day and Night for all subjects
Description
MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
Time Frame
6 months
Title
MDI Cohort: Change in A1C for all subjects
Description
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
Time Frame
6 months
Title
SAP Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8%
Description
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%
Time Frame
6 months
Title
SAP Cohort: Change in A1C (∆A1C) for subjects with baseline A1c ≤ 8%
Description
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%
Time Frame
6 months
Title
SAP Cohort: Time in Hypoglycemic Range during Night for all subjects
Description
SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
Time Frame
6 months
Title
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Description
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
Time Frame
6 months
Title
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Description
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
Time Frame
6 months
Title
SAP Cohort: Time in Hypoglycemic Range during Day and Night for all subjects
Description
SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
Time Frame
6 months
Title
SAP Cohort: Change in A1C for all subjects
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subject is age 2-80 years at time of screening US, Canada, Australia and New Zealand: Subjects 2-80 years of age will be allowed to enroll in the post approval study. Europe: Only subjects ≥7 years of age are allowed to enroll in the post-market study. 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 Subject must have a minimum daily insulin requirement (Total Daily Dose) of equal to or greater than 8 units/day Subjects who are determined by the investigator to be psychologically sound in order to successfully participate in this study 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, if available in the medical records. Subject must be on one of the following management therapies: Multiple daily injections defined by use of rapid analogue with meals and approved long acting analogue (e.g. detemir or glargine) with or without CGM Insulin pump therapy with or without CGM Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily Subject is willing to perform required study procedures Subject is willing to wear the system continuously throughout the study for at least 80% of the time. 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 Subject must be willing to use the study glucose meter system (i.e. along with study meter strips). If subject has celiac disease, it has been adequately treated as determined by the investigator 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 Investigator 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) Humalog® (insulin lispro injection) NovoLog® (insulin aspart) Exclusion Criteria: Subject participated in any Closed Loop study in the past. Subject is unable to tolerate tape adhesive in the area of sensor placement 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 Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study Subject is being treated for hyperthyroidism at time of screening Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit. TSH is not required for subjects 2-13 years of age. 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. 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 Subject is currently abusing illicit drugs or marijuana Subject is currently abusing prescription drugs Subject is currently abusing alcohol Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas at time of screening Subject is using hydroxyurea at the time of screening or plans to use it during the study 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 Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation Subject diagnosed with current moderate to severe eating disorder such as anorexia or bulimia Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia Subjects who are currently being actively treated for cancer. Subject who is designated as a research staff member for this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Troub
Phone
818-576-3142
Email
thomas.troub@medtronic.com
First Name & Middle Initial & Last Name or Official Title & Degree
Briggitte Marinos
Phone
818-576-5373
Email
briggitte.s.marinos@medtronic.com
Facility Information:
Facility Name
Scripps Health System
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Completed
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Completed
Facility Name
Center of Excellence in Diabetes & Endocrinology
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sansum Diabetes Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Completed
Facility Name
SoCal Diabetes
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Completed
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Completed
Facility Name
Barbara Davis Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Completed
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of South Florida Diabetes Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Rodriguez
Phone
813-974-5499
Email
janetrodriguez@health.usf.edu
First Name & Middle Initial & Last Name & Degree
Dorothy Shulman, MD
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Completed
Facility Name
Endocrine Research Solutions
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rocky Mountain Diabetes
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
93404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Malone
Phone
208-522-6005
Email
joann@idahomed.com
First Name & Middle Initial & Last Name & Degree
David Liljenquist, MD
Facility Name
Indiana University Health Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Completed
Facility Name
IDERC
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Borg
Phone
515-643-5118
Email
lborg@iowadiabetes.com
First Name & Middle Initial & Last Name & Degree
Anuj Bhargava, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Grunberger Diabetes Institute
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Individual Site Status
Completed
Facility Name
Initernational Diabetes Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Completed
Facility Name
International Diabetes Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Completed
Facility Name
Washington University St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Completed
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Completed
Facility Name
Sanford Health
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Completed
Facility Name
Texas Diabetes & Endocrinology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Completed
Facility Name
Texas Children's Hospital / Baylor University
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Withdrawn
Facility Name
Diabetes and Glandular Disease Clinic, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terri Ryan
Phone
210-614-8612
Email
terri.ryan@dgdclinic.com
First Name & Middle Initial & Last Name & Degree
Mark S Kipnes, MD
Facility Name
Rainier Clinical Research
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Individual Site Status
Completed
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Completed
Facility Name
Westminster Endocrine & Diabetes Research Society
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W5
Country
Canada
Individual Site Status
Completed
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Necker Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Completed
Facility Name
HCL - Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Completed
Facility Name
Diabeteszentrum für Kinder und Jugendliche, Kinder- und Jugendkrankenhaus Auf der Bult
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Individual Site Status
Completed
Facility Name
A.S.S.T. Spedali Civili
City
Brescia
ZIP/Postal Code
25028
Country
Italy
Individual Site Status
Completed
Facility Name
New Zealand Clinical Research
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antony Watson
Email
antony.watson@otago.ac.nz
First Name & Middle Initial & Last Name & Degree
Martin de Bock, MD
Facility Name
Dunedin Public Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alisa Boucsein
Email
a.boucsein@otago.ac.nz
First Name & Middle Initial & Last Name & Degree
Benjamin Wheeler, MD
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Individual Site Status
Completed
Facility Name
Dept Internal Medicine, Örebro University Hospital
City
Örebro
ZIP/Postal Code
SE-70185
Country
Sweden
Individual Site Status
Completed
Facility Name
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
City
Cambridge
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home

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