NCT01857973

Brief Summary

This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

February 28, 2019

Completed
Last Updated

February 28, 2019

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

May 15, 2013

Results QC Date

March 9, 2018

Last Update Submit

October 19, 2018

Conditions

Type 1 Diabetes

Keywords

HCLType 1 DiabetesSensor

Outcome Measures

Primary Outcomes (1)

  • Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform)

    time in euglycemic range (% of Senosr Glucose (SG) 70-180 mg/dL), Phase 3 (closed-loop using the Next Generation Pump (NGP) platform). The experiment was conducted in a monitored setting which lasted for 12 days with the following stressors: missed meal bolus, exercise, missed transmission, Umax (maximum insulin limit) challenges. The study was conducted in a clinic or hotel/house environment for 12 days/11 nights with no dietary or activity restrictions.

    12 days

Secondary Outcomes (7)

  • Percentage of Time in Euglycemic Range - Exploratory A Phase

    1 day

  • Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase

    1 day

  • Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1

    1 day

  • Percentage of Time in Euglycemic Range - Phase 2

    3 days

  • Percentage of Time in Euglycemic Range - Phase 4

    12 days

  • +2 more secondary outcomes

Study Arms (1)

Hybrid Closed Loop

EXPERIMENTAL

In-clinic evaluation of the HCL System under various conditions.

Device: Hybrid Closed Loop

Interventions

Hybrid Closed LoopDEVICE

The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.

Hybrid Closed Loop

Eligibility Criteria

Age2 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is 2-75 years of age at time of screening
  • A clinical diagnosis of type 1 diabetes as determined by either medical record or source documentation from qualified individual to make medical diagnosis

You may not qualify if:

  • Pump therapy for greater than 6 months with use of real time CGM for any period of time (ie. one day) 3 months prior to screening
  • Adequate venous access as assessed by investigator or appropriate staff
  • Subject should have an established insulin carbohydrate and insulin sensitivity ratio.
  • Subject reports at the time of screening that their average fasting glucose is 60 mg/dL - 200 mg/dL
  • Subject reports at the time of screening that their average total daily insulin dose is 15 units - 110 units. (Insulin pump memory for this information may be used)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

AMCR Institute, Inc. 700 West El Norte Parkway, Suite 201

Escondido, California, 92026, United States

Location

Barbara Davis Center, 1775 Aurora Court, A140

Aurora, Colorado, 80045, United States

Location

Yale University School of Medicine, 2 Church Street South, Suite 404

New Haven, Connecticut, 06519, United States

Location

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

University of Virginia, 617 West Main Street, 4th Floor

Charlottesville, Virginia, 22903, United States

Location

Rainier Clinical Research, 723 SW 10th Street, Suite 100

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Suiying Huang, Statistician
Organization
Medtronic Minimed
suiying.huang@medtronic.com
818-576-3319

Study Officials

  • Scott Lee, MD

    Medtronic

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: subjects undergo treatment with the hybrid closed loop system under various experimental conditions
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 20, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

February 28, 2019

Results First Posted

February 28, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(6)