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Open Access Study protocol

Randomised prospective study for the effect of therapy on residual beta cell function in type-1 diabetes mellitus [ISRCTN70703138]

Thomas Linn1*, Marion Mann2, Markus Mann1, Reinhard G Bretzel1 and Rolf H Boedeker2

Author Affiliations

1 Clinical Research Unit, Medical Clinic 3 and Policlinic, Justus Liebig University, Giessen, Germany

2 Statistics Workgroup, Institute for Medical Informatics, Justus Liebig University, Giessen, Germany

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BMC Endocrine Disorders 2003, 3:5  doi:10.1186/1472-6823-3-5

Published: 10 December 2003

Abstract

Background

Newly diagnosed insulin-dependent diabetes mellitus is characterised by a temporary recovery of endogeneous insulin ("remission") after the beginning of medical treatment with subcutaneous insulin injections. Although most diabetologists think, that insulin reserve is related to reduced occurrence of diabetic long-term complications, such as eye, nerve and kidney disease, there is only one prospective controlled clinical study (the DCCT) addressing this question, however as secondary hypothesis.

Methods/Design

Therefore, we composed a trial consisting of two cohorts with two therapeutic options within each cohort (conventional versus intensive therapy) and a three-year follow-up. In one group the patients are randomly assigned to the treatment regimes to test the statistical alternative hypothesis if variable insulin dosage is superior to fixed insulin injection in preserving insulin reserve measured by C-peptide in serum. Another group includes patients who prefer one of the two therapies, decline randomisation, but consent to follow-up. Apart from the determination of insulin reserve as a biological parameter a second primary endpoint was defined as 'therapeutic failure' according to the criteria of the European Association for the Study of Diabetes. Patients pass a training program to help them self-manage diabetes. A standardised protocol is being set up to minimize centre effects and bias of health care providers. Potential patient dependent bias will be investigated by questionnaires measuring psychic coping processes of people with diabetes. Management of visit dates is directly navigated by the database. Automated visit-reminders are mailed to patients and caregivers to optimise the number of visits on schedule. Data quality is regularly monitored and centres are informed on the results of continuous data management.

Keywords:
Intensive Insulin Therapy; Type-1 Diabetes; Insulin Reserve; Complications