Ignite Creation Date:
2024-05-06 @ 2:51 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02147860
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2014-05-21
Brief Title:
Full Day and Night Closed-Loop With DiAs Platform
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Full Day and Night Closed-Loop With DiAs Platform
Status:
COMPLETED
Status Verified Date:
2015-11
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 overall aim of this proposed research is to determine the safety feasibility and efficacy of the Diabetes Assistant DiAs controller in day and night closed-loop control in children and adolescents with type 1 diabetes over multiple days in a diabetes camp setting This will be addressed in two parts 1 An in residence outpatient study to determine safety and feasibility of the DiAs during 72 continuous hours of day and night glucose control and 2 Camp studies planned for the summer of 2014 with randomization to either full closed-loop or sensor-augmented pump therapy over the duration of 6-7 day diabetes camps
Detailed Description:
This study is an early feasibility study that will test the efficacy of DiAs - a smart-phone-based system compared to sensor augmented therapy in an outpatient setting Twelve study subjects with type 1 diabetes six each at UVa and Stanford University who have experience with insulin pump use at two clinical sites will be recruited The first six subjects recruited will be aged 15-18 years and this will follow with recruitment of six subjects aged 10-14 years This study is designed to mimic the protocol at camp and will include a period of light exercise after breakfast and moderate intensity physical activity after lunch with group activities such as soccer and volleyball The duration of the Outpatient in Residence Study will be 72 hours The data will be reviewed by the Data Safety Monitoring Board DSMB before proceeding to camp studies
The camp study will recruit 48 subjects with type 1 diabetes who have experience with insulin pump therapy Initial studies will be conducted at a camp with older participants aged 15-35 years with at least 5 of the campers between 15-18 years old These studies will be reviewed by the DSMB and if safe we will recruit additional children aged 10-14 years of age The duration of the Diabetes Camp Studies will be up to 7 days6 nights
The camp study will recruit 48 subjects with type 1 diabetes who have experience with insulin pump therapy Initial studies will be conducted at a camp with older participants aged 15-35 years with at least 5 of the campers between 15-18 years old These studies will be reviewed by the DSMB and if safe we will recruit additional children aged 10-14 years of age The duration of the Diabetes Camp Studies will be up to 7 days6 nights
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 |
|---|---|---|---|
| 2014PG-T1D038 | OTHER | The Leona M Harry B Helmsley Charitable Trust Grant | None |