NCT02679287

Brief Summary

The purpose of this study is to use an investigational type of technology called Closed-Loop Control (CLC) Medical Platform System to help control blood sugar in people with type 1 diabetes mellitus in a home setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 8, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 9, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

3.2 years

First QC Date

January 8, 2016

Results QC Date

April 6, 2020

Last Update Submit

June 5, 2020

Conditions

Diabetes Mellitus, Type 1

Keywords

Closed-Loop Control (CLC)Sensor-Augmented Therapy (SAP)USS VirginiaContinuous Glucose Monitor (CGM)Insulin PumpArtificial Pancreas (AP)

Outcome Measures

Primary Outcomes (2)

  • Time <70 mg/dl by CGM

    Overnight CLC achieved by USS+SAP(d) (also known at Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c \< 7.5% vs ≥7.5% and time of day.

    8 weeks

  • Hemoglobin A1c

    Overnight CLC achieved by USS+SAP(d) (also known as Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c \< 7.5% vs ≥7.5% and time of day.

    8 weeks

Secondary Outcomes (7)

  • Time Between 70-180 mg/dL by CGM

    8 weeks

  • Time >180 mg/dL by CGM

    8 weeks

  • Mean Glucose by CGM

    8 weeks

  • Low Blood Glucose Index (LBGI)

    8 weeks

  • High Blood Glucose Index (HBGI)

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d) 1. SAP=sensor-augmented pump only 2. USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight 3. USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control

Device: CLC

Group B

EXPERIMENTAL

Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP 1. SAP=sensor-augmented pump only 2. USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight 3. USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control

Device: CLC

Interventions

CLCDEVICE

The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.

Also known as: Closed Loop Control
Group AGroup B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 1 diabetes for at least one year
  • using insulin for at least 1 year
  • an insulin pump for at least 6 months
  • willingness to switch to lispro (Humalog) or aspart (Novolog) if using glulisine (Apidra).

You may not qualify if:

  • a medical condition or being been treated with medications that might interfere with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

  • Kovatchev BP, Kollar L, Anderson SM, Barnett C, Breton MD, Carr K, Gildersleeve R, Oliveri MC, Wakeman CA, Brown SA. Evening and overnight closed-loop control versus 24/7 continuous closed-loop control for type 1 diabetes: a randomised crossover trial. Lancet Digit Health. 2020 Feb;2(2):e64-e73. doi: 10.1016/S2589-7500(19)30218-3. Epub 2020 Jan 3.

    PMID: 32864597DERIVED

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
Sue Brown, MD
Organization
University of Virginia
sab2f@virginia.edu
434-982-0602

Study Officials

  • Sue A. Brown, MD

    UVA Center for Diabetes Technology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2016

First Posted

February 10, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

June 9, 2020

Results First Posted

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Generally will be available after publications completed.

Locations

US(1)