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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 1 | Device: CLC | Not Applicable |
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
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 |

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)
|
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
|
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 |
- 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.
- 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.
- Time Between 70-180 mg/dL by CGM [ Time Frame: 8 weeks ]Time in target range 70-180 mg/dL measured by CGM
- Time >180 mg/dL by CGM [ Time Frame: 8 weeks ]Time in hyperglycemia range >180 mg/dL measured by CGM
- Mean Glucose by CGM [ Time Frame: 8 weeks ]Mean glucose measured by CGM overall in mmol/L
- 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).
- High Blood Glucose Index (HBGI) [ Time Frame: 8 weeks ]Index measure of high blood glucose risk.
- CGM <70mg/dL [ Time Frame: 8 weeks ]Percentage time <70mg/dL measured by CGM in three study phases combining Group A and B.
- Hemoglobin A1c by Study Session [ Time Frame: 8 weeks ]Hemoglobin A1c after each 8 weeks study session by Group A and Group B.

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

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
United States, Virginia | |
University of Virginia Center for Diabetes Technology | |
Charlottesville, Virginia, United States, 22903 |
Principal Investigator: | Sue A. Brown, MD | UVA Center for Diabetes Technology |
Documents provided by Sue Brown, University of Virginia:
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Closed-Loop Control (CLC) Sensor-Augmented Therapy (SAP) USS Virginia |
Continuous Glucose Monitor (CGM) Insulin Pump Artificial Pancreas (AP) |
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |