A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes

Summary

This study will evaluate the safety, tolerability and efficacy of E-islet 01 in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia

Eligibility

Inclusion Criteria:

* Clinical history of Type 1 Diabetes with \> 5 years of duration
* 2-hour C-peptide level \<0.3 ng/mL after a mixed meal stimulation test
* Under continuous insulin therapy, Participants have at least one of the following conditions:

  1. At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment;
  2. Unaware hypoglycemia evaluated using the Clarke scoring system
* Willing and able to conduct self-blood glucose monitoring as required, with good compliance
* Voluntarily participate and sign the informed consent form

Exclusion Criteria:

* Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab).
* History of malignancy within the past 5 years or undergoing antitumor treatment
* Participation in other clinical trials in the 3 months or islet cell transplant, organ transplant, or cell therapy in the 12 months prior to enrollment
* Other situations judged by the investigator as unsuitable for participation in the trial

Conditions4

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