TZIELD® (teplizumab-mzwv) in Patients with Stage 2 Type 1 Diabetes
Brief description of study
- Are you at risk for type 1 diabetes?
- Are you willing to receive a phone call every 6 months?
For patients treated with TZIELD AND NOT treated with TZIELD
You may qualify to participate in an observational research study
- An observational study (you will not receive any experimental medication)
- Does not require on-site visits
- Participation will not change your treatment or medical care in any way
Compensation for your time provided.
Send us a message below or contact our study coordinator:
Wendy Yang
215-746-8136
wendy.yang@pennmedicine.upenn.edu
Detailed description of study
The Registry for Stage 2 Type 1 Diabetes is:
• An observational study
• Evaluating the long-term safety of TZIELD (teplizumab-mzwv)
• For patients treated with TZIELD
• For patients NOT treated with TZIELD
• Does not require extra visits or changes in your healthcare
About Stage 2 Type 1 Diabetes:
Type 1 (T1D) diabetes is an autoimmune disease that affects the body’s ability to make insulin
and control the sugar level in the blood.
Stage 2 Type 1 diabetes is an early stage of T1D in which blood sugar levels are not normal but
not yet high enough for insulin use.
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.
What should I expect if I join the study?
Enrollment:
• Sign the Informed Consent Form (ICF)
Year 1:
• Follow-up with study doctor
• Routine care visits
• No extra visits as part of study participation
Long-Term Follow-Up:
• Brief phone call every 6 months (twice a year)
• Phone Calls made by UBC to check for any changes in your health
• 9 years of follow-up
• You will receive a $45.00 gift card for compensation for each phone call
Why should I join Registry for Stage 2 Type 1 Diabetes?
• Your participation may help others by increasing the understanding of TZIELD treatment in the delay of Stage 3 type 1 diabetes
• Your participation may benefit patients in the future by providing new safety and medical information
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Type 1 Diabetes, Stage 2 Type 1 Diabetes, T1D
-
Age: 8 Years
-
Gender: All
You may be eligible for this study if you:
1. Are at least 8 years old
2. Have a current diagnosis of Stage 2 type 1 diabetes
3. Plan to begin TZIELD treatment or have started TZIELD treatment within the past 6 months
OR Plan NOT to be treated with TZIELD at the time of enrollment into the study
Find a site
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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.
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