Ignite Creation Date:
2024-05-06 @ 8:13 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02692547
Status:
WITHDRAWN
Last Update Posted:
2018-01-19
First Post:
2015-12-03
Brief Title:
Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes
Sponsor:
Medtronic Diabetes
Organization:
Medtronic Diabetes
Study Overview
Official Title:
Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes
Status:
WITHDRAWN
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study Cancelled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DREAMED
Brief Summary:
The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting
Detailed Description:
This study is a single-arm single-center in clinic Investigation in subjects with type 1 diabetes on insulin pump therapy
Run-in Period A total of up 10 subjects will be enrolled age 18-25 A minimum of 6 days run-in period with the 640G sensor augmented pump will be used to collect sensors and insulin data and to allow the subject to become familiar
Study Period - Camp Following the run-in period subjects will participate in a 5 day 4 night study period in an camp setting during which the CL feature will be studied
Subjects will receive 3 meals each day one night they receive a high fat dinner one morning they will receive breakfast high in carbohydrates
Subjects will be asked to exercise for up to 60 minutes on one day during their study period
Subjects will be asked to take a minimum of 5 fingersticks a day before each meal morning and before bedtime
Run-in Period A total of up 10 subjects will be enrolled age 18-25 A minimum of 6 days run-in period with the 640G sensor augmented pump will be used to collect sensors and insulin data and to allow the subject to become familiar
Study Period - Camp Following the run-in period subjects will participate in a 5 day 4 night study period in an camp setting during which the CL feature will be studied
Subjects will receive 3 meals each day one night they receive a high fat dinner one morning they will receive breakfast high in carbohydrates
Subjects will be asked to exercise for up to 60 minutes on one day during their study period
Subjects will be asked to take a minimum of 5 fingersticks a day before each meal morning and before bedtime
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