Registry for Stage 2 Type 1 Diabetes

Overview

About this study

The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

TZIELD-Exposed Cohort

Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD treatment according to the currently approved label or who have initiated TZIELD treatment within 6 months prior to enrollment:
Day 1: 65 mcg/m2
Day 2: 125 mcg/m2
Day 3: 250 mcg/m2
Day 4: 500 mcg/m2
Days 5 through 14: 1,030 mcg/m2 per day
Cumulative dose is approximately 11,240 mcg/m2
Appropriate written informed consent/assent as applicable for the age of the patient

TZIELD-Unexposed Cohort

Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD
Appropriate written informed consent/assent as applicable for the age of the patient

Exclusion Criteria:

Patients who initiated TZIELD treatment more than 6 months prior to enrollment
Patients who had participated in a previous clinical trial for TZIELD
Patients in an ongoing clinical trial of an investigational product or who had ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 08/21/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Yogish Kudva, M.B.B.S.	Open for enrollment	Contact information: Corey Kurek (507) 255-0316 Reid.Corey@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yogish Kudva, M.B.B.S.

Open for enrollment

Contact information:

Corey Kurek

(507) 255-0316

Reid.Corey@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials