Encapsulated islets as a therapy for type 1 diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12609000192280
• Lead Sponsor: South Eastern Sydney Illawarra Area Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

normal body weight, that is, body mass index < 30, but ideally <25.
(b) age 18-50 years
(c) no insulin production from their pancreas
(d) (i) difficulty in controlling blood glucose levels despite compliance with insulin injections, physical activity and food intake. This difficulty is impacting on the quality of life.
(ii) unable to recognise the symptoms of low blood glucose levels for whom no other strategy has been successful.
(iii) special situations, e.g., rapid falls in blood glucose levels resulting in epilepsy and where anti-epileptic medication is unsuitable.

Each case will be considered on its merit, but the benefit must exceed the risk.

Exclusion Criteria

1. Does not fit the above criteria.
2. Residual function of recipient’s pancreatic beta cells, as assessed by C-peptide production.
3. Body mass index > 30.
4. Pregnancy.
5. Non-agreement by patient’s endocrinologist.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To normalize blood glucose levels in people with type 1 diabetes patients and no previous evidence of beta cell function, without the need for exogenous insulin.<br><br>Method used for assessment:<br>1. Blood glucose monitoring by patients<br>2. Daily exogenous insulin requirements.[Daily for up to 12 months after islet infusion]