Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-30 @ 11:00 AM
Study NCT ID:
NCT03263494
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2017-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D)
Sponsor:
Jaeb Center for Health Research
Organization:
Study Overview
Official Title:
CGM Intervention in Teens and Young Adults With T1D (CITY): A Randomized Clinical Trial to Assess the Efficacy and Safety of Continuous Glucose Monitoring in Young Adults 14-<25 With Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2020-03
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:
CITY
Brief Summary:
Adolescents and young adults with T1D and poor glycemic control (age 14-\< 25 years, T1D duration \>12 months, HbA1c 7.5-\<11.0%, using an insulin pump or MDI)) will be randomly assigned to either CGM or BGM. Sample size will be 150. The primary outcome assessment will be HbA1c after 6 months. Secondary outcomes will include HbA1c, CGM metrics (control group will wear blinded CGM at 13 and 24 weeks), and quality of life measures. The randomized trial will be followed by a 6-month extension study during which the RCT control group will initiate CGM and the RCT CGM group will continue CGM.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: