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Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679287
Recruitment Status : Completed
First Posted : February 10, 2016
Results First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Roche Diagnostic Ltd.
TypeZero Technologies, LLC
Tandem Diabetes Care, Inc.
DexCom, Inc.
Information provided by (Responsible Party):
Sue Brown, University of Virginia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: CLC Not Applicable

Detailed Description:

The CLC is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. 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.These functionalities occur in a randomized cross-over design, each occurring for 8 weeks. These modalities are:

  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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control
Study Start Date : February 2016
Actual Primary Completion Date : April 2019
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A

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
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.
Other Name: Closed Loop Control
Experimental: Group B

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
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.
Other Name: Closed Loop Control


Outcome Measures
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Primary Outcome Measures :
  1. Time <70 mg/dl by CGM [ Time Frame: 8 weeks ]
    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.

  2. Hemoglobin A1c [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Time Between 70-180 mg/dL by CGM [ Time Frame: 8 weeks ]
    Time in target range 70-180 mg/dL measured by CGM

  2. Time >180 mg/dL by CGM [ Time Frame: 8 weeks ]
    Time in hyperglycemia range >180 mg/dL measured by CGM

  3. Mean Glucose by CGM [ Time Frame: 8 weeks ]
    Mean glucose measured by CGM overall in mmol/L

  4. Low Blood Glucose Index (LBGI) [ Time Frame: 8 weeks ]
    Index measure of low blood glucose risk. This is an index that indicates risk of hypoglycemia with low values indicating lower risk of hypoglycemia (particularly values 1 or lower).

  5. High Blood Glucose Index (HBGI) [ Time Frame: 8 weeks ]
    Index measure of high blood glucose risk.

  6. CGM <70mg/dL [ Time Frame: 8 weeks ]
    Percentage time <70mg/dL measured by CGM in three study phases combining Group A and B.

  7. Hemoglobin A1c by Study Session [ Time Frame: 8 weeks ]
    Hemoglobin A1c after each 8 weeks study session by Group A and Group B.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • a medical condition or being been treated with medications that might interfere with the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679287


Locations
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United States, Virginia
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Roche Diagnostic Ltd.
TypeZero Technologies, LLC
Tandem Diabetes Care, Inc.
DexCom, Inc.
Investigators
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Principal Investigator: Sue A. Brown, MD UVA Center for Diabetes Technology
  Study Documents (Full-Text)

Documents provided by Sue Brown, University of Virginia:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] August 6, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sue Brown, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT02679287    
Other Study ID Numbers: 18617
R01DK085623 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2016    Key Record Dates
Results First Posted: June 9, 2020
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Generally will be available after publications completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Sue Brown, University of Virginia:
Closed-Loop Control (CLC)
Sensor-Augmented Therapy (SAP)
USS Virginia
 Continuous Glucose Monitor (CGM)
Insulin Pump
Artificial Pancreas (AP)
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases