Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177691
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-11
Brief Title:
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes CLVer Extension Study
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes CLVer Extension Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
CLVerEx
Brief Summary:
The purpose of this extension study is to continue to follow the participants who completed the CLVer RCT for up to 3 additional years The goal for Cohort A is to evaluate the longer-term effects of verapamil on preservation of β-cell function as measured by C-peptide levels obtained during a mixed meal tolerance test MMTT For both Cohorts A and B the goal is to determine if the high degree of glycemic control achieved during CLVer with HCL can be maintained once the intensive engagement of the study team is discontinued At the completion of the RCT study treatments end Thus during the extension study diabetes management is performed as part of usual care and there is no study treatment
Detailed Description:
Participants who complete the CLVer RCT will be eligible to enroll in the CLVer Extension Study Informed consent and assent when applicable will be obtained Participants will be contacted every 3 months at which time continuous glucose monitoring CGM data will be obtained if a CGM device is being used and medical history including recent point-of-care or local laboratory HbA1c values will be reviewed a usual care visit performed by study staff may be considered a study contact A study visit will occur yearly to update the diabetes and medical history measure height and weight determine Tanner staging download CGM data if available perform an MMTT and obtain blood samples for central lab measurement of HbA1c and plasma for storage if consented Other than the central lab samples there are no study-specific procedures or data collection that would not be performed as part of standard care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None