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HCL and verapamil for Type 1 Diabetes (CLVer Trial)

Phase 3
Waitlist Available
Research Sponsored by Jaeb Center for Health Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
New-onset stage 3 T1D within 21 days of diagnosis (timed from start of insulin therapy), with ability to be randomized within 31 days of diagnosis (time from diagnosis to screening can be longer provided all screening testing can be completed within 31 days of diagnosis)
At least one positive type 1 diabetes auto-antibody
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 13, 26, 39 weeks and 1 year
Awards & highlights

CLVer Trial Summary

This trial is testing a new system to help people with type 1 diabetes better manage their disease and preserve their β-cell function. The trial is divided into two groups, those who weigh more and those who weigh less, with different treatments being tested for each group.

Eligible Conditions
  • Type 1 Diabetes

CLVer Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

CLVer Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 13, 26, 39 weeks and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 13, 26, 39 weeks and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
C-peptide
Secondary outcome measures
>=70% CGM time in range
Basal:Bolus ratio
C-Peptide
+17 more

CLVer Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: HCL and verapamilActive Control2 Interventions
Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations. Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. [Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.]
Group II: HCL and placeboActive Control2 Interventions
Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations. Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. [Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.]
Group III: non-HCL and verapamilActive Control2 Interventions
Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider. Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. [Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.]
Group IV: non-HCL and placeboPlacebo Group2 Interventions
Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider. Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. [Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.]

Find a Location

Who is running the clinical trial?

Jaeb Center for Health ResearchLead Sponsor
152 Previous Clinical Trials
34,621 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
231 Previous Clinical Trials
111,638 Total Patients Enrolled
University of MinnesotaOTHER
1,370 Previous Clinical Trials
1,587,944 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~24 spots leftby Mar 2025