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Completed

NCT Number: NCT02679287

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

About this study

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:

  • SAP=sensor-augmented pump only
  • USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight
  • USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CLC

Device

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 names: Closed Loop Control

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • DexCom, Inc.
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Roche Diagnostic Ltd.
  • Tandem Diabetes Care, Inc.
  • TypeZero Technologies, LLC

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 10, 2016
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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