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

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.

Conditions

• Type1 Diabetes

Interventions

DEVICE

HCL

Hybrid Closed Loop therapy

DRUG

verapamil 120mg tablet

verapamil tablet

DEVICE

non-HCL

Usual diabetes care

DRUG

placebo

placebo pill manufactured to mimic verapamil 120mg tablet

Sponsors & Collaborators

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• DexCom, Inc.

  collaborator INDUSTRY

• Medtronic

  collaborator INDUSTRY

• Tandem Diabetes Care, Inc.

  collaborator INDUSTRY

• Jaeb Center for Health Research

  lead OTHER

Principal Investigators

• Antoinette Moran, MD · University of Minnesota

• Gregory Forlenza, MD · Barbara Davis Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

7 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-09

Primary Completion

2022-09-15

Completion

2022-09-30

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations