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

A study testing CLC in people with Diabetes Mellitus, Type 1, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: CLC
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 1 siteUnited States
Study dates: Feb 2016to Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903

Other trials in United States

About this study

Read the 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:

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

Conditions: Diabetes Mellitus, Type 1
Being tested: CLC
Keywords: Closed-Loop Control (CLC), Sensor-Augmented Therapy (SAP), USS Virginia, Continuous Glucose Monitor (CGM), Insulin Pump, Artificial Pancreas (AP)
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CLCDevice
Also called Closed Loop Control
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.

Study groups in NCT02679287
Study group	Role	What they receive
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 Receives: 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 Receives: Device: CLC

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 8 weeks

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016Apr 2019

First posted10 Feb 2016 (estimated)
Study startFeb 2016
Primary completionApr 2019
Study completionApr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
More trials run by University of VirginiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02679287
Sponsor's protocol ID: 18617
Other IDs: R01DK085623
Status last verified: Jun 2020
First submitted: 8 Jan 2016
Last updated: 9 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes

Publications

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.
PubMed 32864597

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control
ClinicalTrials.gov ID: NCT02679287
Acronym / sponsor ID: 18617
Conditions: Diabetes Mellitus, Type 1
Keywords: Closed-Loop Control (CLC), Sensor-Augmented Therapy (SAP), USS Virginia, Continuous Glucose Monitor (CGM), Insulin Pump, Artificial Pancreas (AP)
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Roche Diagnostic Ltd., TypeZero Technologies, LLC, Tandem Diabetes Care, Inc., DexCom, Inc.
Study start: Feb 2016
Primary completion: Apr 2019 (actual)
Study completion: Apr 2019 (actual)
First posted: 10 Feb 2016 (estimated)
Results: Posted 9 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Device: CLCOrder 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
Group B	Experimental	Device: CLCOrder 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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CLCAlso: Closed Loop ControlThe 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.	Device	Group A, Group B

Primary outcome

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.

7 secondary outcomes

Time Between 70-180 mg/dL by CGM
Time frame: 8 weeks
Time >180 mg/dL by CGM
Time frame: 8 weeks
Mean Glucose by CGM
Time frame: 8 weeks
Low Blood Glucose Index (LBGI)
Time frame: 8 weeks
High Blood Glucose Index (HBGI)
Time frame: 8 weeks
CGM <70mg/dL
Time frame: 8 weeks
Hemoglobin A1c by Study Session
Time frame: 8 weeks

Results and safety

Results posted to the registry on 9 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	47	43
Group B	46	40

Primary outcome: Time <70 mg/dl by CGM

Time frame: 8 weeks. Mean (Standard Deviation). Unit: percentage of time

Measure	Group A and Group B Combined n = 78
CGM Time<70 mg/dL in SAP	4.0 (3.3)
CGM Time<70 mg/dL in Evening-Overnight CLC	2.2 (1.8)

Group A and Group B Combined: Mean Difference (Final Values): 1.8 (95% CI 1.2 to 2.4), p <0.0001, Mixed Models Analysis

Population analysed: This primary analysis was confined to the phase of the study comparing SAP to Evening-Night CLC only when combining group A and B. Data on 24/7 CLC phase is included in secondary outcomes.

Primary outcome: Hemoglobin A1c

Time frame: 8 weeks. Mean (Standard Deviation). Unit: percentage of glycated hemoglobin

Measure	Group A and Group B Combined n = 78
HbA1c at baseline	7.42 (1.03)
HbA1c at end of study	7.11 (0.86)

Population analysed: This primary analysis was confined to the phase of the study comparing SAP to Evening-Night CLC only when combining group A and B and included the baseline HbA1c and final HbA1c. Data on HbA1c by study phase is included in secondary outcomes.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 10-11 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sensor-Augmented Pump Therapy (SAP)	1 of 93 (1.1%)	5 of 93 (5.4%)	0 of 93
Evening and Overnight Closed-Loop Control	1 of 93 (1.1%)	14 of 93 (15.1%)	0 of 93
24/7 Closed-Loop Control	0 of 93 (0%)	7 of 93 (7.5%)	0 of 93
Other	1 of 93 (1.1%)	9 of 93 (9.7%)	0 of 93

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32864597Kovatchev 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.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sue A. Brown, MD principal investigator

UVA Center for Diabetes Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CLC in people with Diabetes Mellitus, Type 1, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time <70 mg/dl by CGM (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02679287, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.