NCT02844517

Brief Summary

The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
4 countries

10 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

July 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

July 21, 2016

Last Update Submit

May 1, 2018

Conditions

Diabetes Mellitus, Type 1

Keywords

Artificial PancreasClosed Loop ControlContinuous Glucose Monitor (CGM)

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff.

    2 weeks

Study Arms (1)

Artificial Pancreas

EXPERIMENTAL

The primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff.

Device: Artificial Pancreas

Interventions

Artificial PancreasDEVICE

Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump and continuous glucose monitor. This AP system is designed to help control blood sugar in people living with type 1 diabetes.

Also known as: inControl Diabetes Medical Platform
Artificial Pancreas

Eligibility Criteria

Age14 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
  • Use of an insulin pump for at least 6 months with established parameters for basal rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3 months.
  • Age 14.0 to \<75.0 years
  • HbA1c level \<10.5% at screening
  • For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  • Have care partner committed to participating in all training activities, knowledgeable at all times of the participants location, and being present and available to provide assistance when the system is being used at night
  • Willingness, if using the closed-loop system, to stop closed-loop when taking acetaminophen and avoid closed-loop for at least 4 hours afterward
  • Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
  • Willingness to establish network connectivity on a daily basis either via local Wi-Fi network or via a study-provided cellular service
  • Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
  • Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra)
  • Total daily insulin dose (TDD) less than 100 U/day

You may not qualify if:

  • More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
  • More than one episode of severe hypoglycemia involving seizure of loss of consciousness in the 6 months prior to enrollment
  • Medical need for chronic acetaminophen
  • Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals).
  • Hemophilia or any other bleeding disorder
  • A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
  • Participation in another pharmaceutical or device trial at the time of enrollment or during the study
  • Employed by, or having immediate family members employed by TypeZero Technologies, LLC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

William Sansum Diabetes Center

Santa Barbara, California, 93105, United States

Location

Stanford University

Stanford, California, 94304, United States

Location

Barbara Davis Center, University of Colorado

Aurora, Colorado, 80045, United States

Location

Harvard University (Joslin Diabetes Center)

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Mt. Sinai

New York, New York, 10029, United States

Location

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

University of Montpellier

Montpellier, France

Location

University of Padova

Padua, Italy

Location

Academic Medical Center

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Artificial OrgansSurgical EquipmentEquipment and Supplies

Study Officials

  • Boris P. Kovatchev, PhD

    University of Virginia Center for Diabetes Technology

    PRINCIPAL INVESTIGATOR

  • Stacey M. Anderson, MD

    University of Virginia Center for Diabetes Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial. Study subjects will wear the study insulin pump and CGM for approximately 2-4 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Chair

Study Record Dates

First Submitted

July 21, 2016

First Posted

July 26, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

May 7, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

Not yet determined

Locations

IT(1)FR(1)NL(1)US(7)