Clinical trial NCT06177691: Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study
Official title: Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Type1 Diabetes
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: University of Minnesota
First posted: 2023-12-20
Enrollment: 77
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who complete the CLVer RCT 12 month visit. RCT participants were youth aged 7-\<18 years at RCT screening with newly diagnosed stage 3 type 1 diabetes.

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.

Eligibility criteria: Completed CLVer RCT 12 month visit and willing to join observational extension.

Primary outcomes:
measure: C-peptide
timeFrame: Randomization, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4
Secondary outcomes:
measure: HbA1c
timeFrame: Randomization, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4
measure: CGM Metrics
timeFrame: 6, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4
measure: Severe hypoglycemia episodes
timeFrame: Year 4
measure: Diabetic ketoacidosis events
timeFrame: Year 4
measure: Hospitalizations
timeFrame: Year 4
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: University of Minnesota
name: Antoinette Moran, MD
role: STUDY_CHAIR
affiliation: Barbara Davis Center
name: Gregory Forlenza, MD
role: STUDY_CHAIR
References: