Contact information
Type
Scientific
Primary contact
Dr Thomas Linn
ORCID ID
Contact details
Clinical Research Unit
3rd Medical Clinic and Policlinic
Justus Liebig University
Giessen
Rodthohl 6
D-35385
Germany
+49 (0)641 99 42841
thomas.linn@innere.med.uni-giessen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Type 1 diabetes mellitus
Intervention
Conventional or intensive insulin therapy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2003
Overall trial end date
01/01/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant 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
Recruitment start date
01/01/2003
Recruitment end date
01/01/2005
Locations
Countries of recruitment
Germany
Trial participating centre
Clinical Research Unit
Giessen, Rodthohl 6
D-35385
Germany
Funders
Funder type
University/education
Funder name
Justus Liebig University (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Protocol in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=14667244
Publication citations
-
Protocol
Linn T, Mann M, Mann M, Bretzel RG, Boedeker RH, Randomised prospective study for the effect of therapy on residual beta cell function in type-1 diabetes mellitus [ISRCTN70703138]., BMC Endocr Disord, 2003, 3, 1, 5, doi: 10.1186/1472-6823-3-5.