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

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University of Virginia

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Treatments

Device: CLC

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT02679287
18617
R01DK085623 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment

103 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

103 participants in 2 patient groups

Group A
Experimental group
Description:
Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d) 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
Treatment:
Device: CLC
Group B
Experimental group
Description:
Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP 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
Treatment:
Device: CLC

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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