Ignite Creation Date:
2024-05-06 @ 7:49 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02604524
Status:
COMPLETED
Last Update Posted:
2018-09-19
First Post:
2015-11-06
Brief Title:
Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM The AP Ski Camp
Sponsor:
Daniel Chernavvsky MD CRC
Organization:
University of Virginia
Study Overview
Official Title:
Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM The AP Ski Camp
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The biggest challenges for glycemic control during the day time involve meals and exercise variations which are impacted by age fitness level duration intensity and history of exercise Meal variability has the benefit that meals are typically announced and quantified Glucose control around exercise on the other hand is more complicated if the patient doesnt announce a change in activity level
Detailed Description:
The object of this study is to evaluate the Closed-Loop Control CLC in an environment where muscle glycogen is systematically depleted glucose uptake systematically increased and meal sizes are naturally larger than normal a week of camp at high altitude with the concomitant variable of oxygen consumption that this environment involves during the winter that will expose and challenge the different components of the system during cold temperatures and with twice daily practice of physical activity designed to deplete glycogen reserves such as skiing
This proposal aims to demonstrate the superiority of the CLC also known as Artificial Pancreas AP compared to the state-of-the art system available on the market Sensor-augmented pump SAP This system has shown to diminish hypoglycemic events by setting the alarms on the continues glucose monitor CGM and taken action such as performing self-monitoring blood glucose SMBG and treating if it is confirm to be low
This proposal aims to demonstrate the superiority of the CLC also known as Artificial Pancreas AP compared to the state-of-the art system available on the market Sensor-augmented pump SAP This system has shown to diminish hypoglycemic events by setting the alarms on the continues glucose monitor CGM and taken action such as performing self-monitoring blood glucose SMBG and treating if it is confirm to be low
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DP3DK106826-01 | NIH | None | httpsreporternihgovquickSearchDP3DK106826-01 |