Effect of therapy on residual beta cell function in type-1 diabetes mellitus

ISRCTN	ISRCTN70703138
DOI	https://doi.org/10.1186/ISRCTN70703138
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Thomas Linn
Scientific

Clinical Research Unit
3rd Medical Clinic and Policlinic
Justus Liebig University
Giessen, Rodthohl 6
D-35385
Germany

Phone	+49 (0)641 99 42841
Email	thomas.linn@innere.med.uni-giessen.de

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	1. Under consideration of baseline data the difference of C-peptide levels between patients under intensive therapy and conventional therapy depends on the willingness of the patients to take part in such a clinical study 2. The failure rate of intensive therapy is less than the rate of conventional therapy
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Type 1 diabetes mellitus
Intervention	Conventional or intensive insulin therapy
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2003
Completion date	01/01/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Men or women aged 18 - 40 years at diagnosis 2. Established Type-1 Diabetes diagnosed up to three months ago 3. Consent to participate in a diabetes training programme 4. Informed consent before enrolment
Key exclusion criteria	1. History of neuropathy, nephropathy, and retinopathy of other than diabetes related origin 2. Negative C-peptide level at diagnosis 3. History of psychiatric disease or drug or alc ohol abuse 4. Treatment with oral antidiabetic medication 5. Subject unlikely to comply with the protocol (e.g. inability or unwillingness to participate adequate training or to complete diaries appropriately) or to understand the nature and the scope of the study
Date of first enrolment	01/01/2003
Date of final enrolment	01/01/2005

Clinical Research Unit

Giessen, Rodthohl 6
D-35385
Germany

Justus Liebig University (Germany)
University/education

-
Giessen Rodthohl 6
D-35385
Germany

"ROR"	https://ror.org/033eqas34

University/education

Justus Liebig University (Germany)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	10/12/2003		Yes	No