Registry for Stage 2 Type 1 Diabetes

Study on Long-term Effects of Investigational Medication in Early Stage Type 1 Diabetes

Recruiting
All
Phase N/A
200 participants needed
9 Locations

Study Overview

Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin.

TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D.

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Type 1 Diabetes
  • Gender: All

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

Updated on 11 Dec 2024. Study ID: NCT06481904

This study investigates Stage 2 Type 1 Diabetes (T1D), which is an early stage of the disease where blood sugar levels are abnormal but not yet causing symptoms. The purpose of this study is to understand more about patients with Stage 2 T1D and the long-term effects of an investigational medication used as part of standard care.

Participants will be divided into two study arms: those who have been treated with the investigational medication and those who have not. The study will collect information on the health and treatment outcomes of these patients over time.

  • Who can participate: Individuals aged 8 years and older in the US diagnosed with Stage 2 T1D. Participants must either be planning to start or have started treatment with the investigational medication within the last 6 months, or not be treated with it at all.
  • Study Details: Participants will be observed for their health outcomes. Those in the treatment arm will receive the investigational medication, while others will not.

Find a Study Location to Connect

What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site