Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study

Type1 Diabetes Clinical Trial

— CLVerEx  

Official title:

Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06177691
• Other study ID #: CLVerEx
• Status: Active, not recruiting
• Start date: May 7, 2021
• Est. completion date: December 18, 2025

Study information

• Verified date: December 2023
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 77
• Est. completion date: December 18, 2025
• Est. primary completion date: December 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years
• Eligibility: Completed CLVer RCT 12 month visit and willing to join observational extension.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes

Locations

Country	Name	City	State
United States	Barbara Davis Center	Aurora	Colorado
United States	Indiana University	Indianapolis	Indiana
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of Minnesota	Minneapolis	Minnesota
United States	Yale University	New Haven	Connecticut
United States	Stanford University	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	Juvenile Diabetes Research Foundation, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-peptide	The primary outcome is the C-peptide measured during the MMTT annually. This is measured as the area under the stimulated C-peptide curve (AUC). AUC is computed using a trapezoidal rule, which is a weighted sum of the C-peptide values over the 120 min. Peak C-peptide also will be computed.	Randomization, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4
Secondary	HbA1c	HbA1c outcomes, measured annually, will include the following: Mean HbA1c; Percentage of participants with an HbA1c <7.5%, <7.0% and <6.5%	Randomization, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4
Secondary	CGM Metrics	CGM metrics will be computed for each time point of data collection. CGM-derived indices will be computed for 24 hours, daytime (6AM to midnight) and nighttime (midnight to 6AM). The Statistical Analysis Plan (SAP) will describe how CGM derived indices will be calculated. The following metrics will be computed: Mean glucose; Percentage of sensor glucose from 70 to 180 mg/dL; Percentage of sensor glucose >180 and >250 mg/dL; Percentage of sensor glucose <54 and <70 mg/dL; Coefficient of variation	6, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4
Secondary	Severe hypoglycemia episodes	Frequency of episodes of severe hypoglycemia by cohort group.	Year 4
Secondary	Diabetic ketoacidosis events	Frequency of episodes of diabetic ketoacidosis by cohort group.	Year 4
Secondary	Hospitalizations	Frequency of hospitalizations by cohort group.	Year 4