Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes
Status:
Active, not recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Jaeb Center for Health Research
Collaborators:
DexCom, Inc. Juvenile Diabetes Research Foundation Medtronic Tandem Diabetes Care, Inc. University of Minnesota