Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/21/2018 |
| Start Date: | February 2016 |
| End Date: | April 2019 |
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.
Control (CLC) Medical Platform System to help control blood sugar in people with type 1
diabetes mellitus in a home setting.
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)= SAP during day and CLC starting at dinner and continuing overnight
3. USS+CLC (d)= 24-hour Day and Night 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)= SAP during day and CLC starting at dinner and continuing overnight
3. USS+CLC (d)= 24-hour Day and Night Closed Loop Control
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
We found this trial at
1
site
Charlottesville, Virginia 22903
Phone: 434-982-6479
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