Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Type1 Diabetes

In brief

Randomized trial of youth aged 7-\<18 years with newly diagnosed stage 3 type 1 diabetes (T1D) to assess the effect of both (1) near-normalization of glucose concentrations achieved through use of a hybrid closed loop (HCL) system and (2) verapamil on preservation of β-cell function 12 months after diagnosis. Participants with body weight ≥30 kg (Cohort A) will be randomly assigned in a factorial design to (1) HCL plus intensive diabetes management or usual care with no HCL and (2) verapamil or placebo. Participants with body weight \<30 kg (Cohort B) will be randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes management or to usual care with no HCL.

Key facts

Study ID

NCT04233034

Run by

Jaeb Center for Health Research

People needed

113

Starts

2020-07-09

Expected to finish

2022-09-30

Last updated by the study team

2024-11-27

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

Where it is running

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

Full record on ClinicalTrials.gov

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