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

NCT02748018 | Completed Results DMC FDA Device

• 1 other identifier: CEP 304
• Study Type: interventional
• Target: 959
• Locations: 9 countries
• Sites: 36

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)

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (6)

• CSII Cohort: Baseline A1C > 8%: Change in A1C (∆A1C)

  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 subjects with baseline A1C \> 8%

  Baseline and end of 6-month study period

• CSII Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range

  CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%

  6 months study period

• MDI Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)

  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 subjects with baseline A1c \> 8%

  Baseline and end of 6-month study period

• MDI Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range

  MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%

  6 months study period

• SAP Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)

  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 subjects with baseline A1c \> 8%

  Baseline and end of 6-month study period

• SAP Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range

  SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%

  6 months study period

Secondary Outcomes (21)

• CSII Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range

  6 months study period

• CSII Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)

  Baseline and end of 6-month study period

• CSII Cohort: Time in Hypoglycemic Range During Night for All Subjects

  6 months study period

• CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects

  6 months study period

• CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects

  6 months study period

Study Arms (2)

Hybrid Closed Loop Arm

EXPERIMENTAL

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

Device: 670G and 770G Insulin Pump

Control Arm

ACTIVE COMPARATOR

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

Interventions

670G and 770G Insulin Pump DEVICE

Medtronic 670G and 770G Hybrid Closed Loop Systems

Hybrid Closed Loop Arm

Subject's Current Diabetes Therapy DEVICE

Subject will use current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump).

Control Arm

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (36)

Scripps Health System

La Jolla, California, 92037, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Center of Excellence in Diabetes & Endocrinology

Sacramento, California, 95821, United States

Location

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

SoCal Diabetes

Torrance, California, 90505, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

University of South Florida Diabetes Center

Tampa, Florida, 33612, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Endocrine Research Solutions

Roswell, Georgia, 30076, United States

Location

Rocky Mountain Diabetes

Idaho Falls, Idaho, 93404, United States

Location

Indiana University Health Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

IDERC

Des Moines, Iowa, 50265, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Grunberger Diabetes Institute

Bloomfield Hills, Michigan, 48302, United States

Location

Initernational Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University St. Louis

St Louis, Missouri, 63110, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

Texas Diabetes & Endocrinology

Austin, Texas, 78731, United States

Location

Diabetes and Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States

Location

Rainier Clinical Research

Renton, Washington, 98057, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

Westminster Endocrine & Diabetes Research Society

New Westminster, British Columbia, V3L 3W5, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, K1H 8L1, Canada

Location

Hôpital Necker Enfants Malades

Paris, 75015, France

Location

HCL - Lyon Sud

Pierre-Bénite, 69495, France

Location

Diabeteszentrum für Kinder und Jugendliche, Kinder- und Jugendkrankenhaus Auf der Bult

Hanover, 30173, Germany

Location

A.S.S.T. Spedali Civili

Brescia, 25028, Italy

Location

New Zealand Clinical Research

Christchurch, 8011, New Zealand

Location

Dunedin Public Hospital

Dunedin, 9016, New Zealand

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Dept Internal Medicine, Örebro University Hospital

Örebro, SE-70185, Sweden

Location

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

Cambridge, United Kingdom

Location

Related Publications (1)

• Jendle JH, Garg SK, Thivolet C, Weinstock RS, Hirsch IB, Evans M, Griffin KJ, Philis-Tsimikas A, Wheeler BJ, Kipnes MS, Carlson AL, Buckingham BA, Bhargava A, Bode BW, Lawson ML, Criego AB, McGill JB, Reed JCH, Prakasam G, Grunberger G, Girelli A, Martinez-Brocca MA, Christiansen MP, de Bock MI, Kudva YC, Lee SW, Yovanovich C, Shin JJ, Cordero TL, McVean JJF, Vigersky RA. Automated basal insulin delivery versus multiple daily injections in type 1 diabetes: results from a randomized parallel controlled trial. Front Endocrinol (Lausanne). 2025 Dec 19;16:1716587. doi: 10.3389/fendo.2025.1716587. eCollection 2025.

  PMID: 41488135 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Colleen Haberman, Sr. Clinical Research Manager
• Organization: Medtronic Diabetes

colleen.p.haberman@medtronic.com

6127503275

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 22, 2016
• Study Start: May 25, 2017
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); ES (1); FR (2); NZ (2); GB (1); US (25); DE (1); IT (1); SE (1)