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

Part of paid clinical trials in La Jolla, California.

Sponsor
Medtronic MiniMed, Inc.
Study ID
NCT02748018
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 670G and 770G Insulin Pump — DEVICE
    Medtronic 670G and 770G Hybrid Closed Loop Systems
  • 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).

Study Details

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)

Key Dates

Start date
May 25, 2017
Status verified
Jul 2025
Primary completion
Nov 1, 2023
Completion
Nov 1, 2023

Study Design

Enrollment
959 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hybrid Closed Loop Arm
    The HCL Arm will use the MiniMed System (i.e., using Auto Mode) for 6 months during the study period.
  • 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).

Primary Outcome Measure

CSII Cohort: Baseline A1C > 8%: Change in A1C (∆A1C) [ Time Frame: Baseline and end of 6-month study period ]

Locations (25)

FacilityCityStateZIPSite coordinators
Scripps Health SystemLa JollaCalifornia92037-
Stanford UniversityPalo AltoCalifornia94304-
Center of Excellence in Diabetes & EndocrinologySacramentoCalifornia95821-
Sansum Diabetes Research InstituteSanta BarbaraCalifornia93105-
SoCal DiabetesTorranceCalifornia90505-
Diablo Clinical ResearchWalnut CreekCalifornia94598-
Barbara Davis CenterAuroraColorado80045-
University of South Florida Diabetes CenterTampaFlorida33612-
Atlanta Diabetes AssociatesAtlantaGeorgia30318-
Endocrine Research SolutionsRoswellGeorgia30076-
Rocky Mountain DiabetesIdaho FallsIdaho93404-
Indiana University Health Riley Hospital for ChildrenIndianapolisIndiana46202-
IDERCDes MoinesIowa50265-
University of MichiganAnn ArborMichigan48109-
Grunberger Diabetes InstituteBloomfield HillsMichigan48302-
Initernational Diabetes CenterMinneapolisMinnesota55416-
International Diabetes CenterMinneapolisMinnesota55416-
Mayo ClinicRochesterMinnesota55905-
Washington University St. LouisSt LouisMissouri63110-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Sanford HealthSioux FallsSouth Dakota57104-
Texas Diabetes & EndocrinologyAustinTexas78731-
Diabetes and Glandular Disease Clinic, P.A.San AntonioTexas78229-
Rainier Clinical ResearchRentonWashington98057-
University of WashingtonSeattleWashington98105-

Find similar trials in La Jolla, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Scripps Health System· La Jolla, CAStanford University· Palo Alto, CACenter of Excellence in Diabetes & Endocrinology· Sacramento, CASansum Diabetes Research Institute· Santa Barbara, CASoCal Diabetes· Torrance, CADiablo Clinical Research· Walnut Creek, CA

Related Studies