| Outcome Measures: |
Primary: Relative thickness as assessed by MRI, The relative thickness will be used instead of raw data of the MRI measurements as given by the thickness of the most atrophic region related to the thickness of the reference region of the same patient (normal tissue). The change (increase) of the thickness is defined as difference between the relative thicknesses of the same atrophic region (given as percentage of the same reference region) at 6 months and study begin., at 6 months | Secondary: Relative thickness as assessed by MRI, Change of relative thickness (as defined above) at 6 and 12 months in the control group, at 6 and 12 months|Relative thickness as assessed by MRI, Change of relative thickness (as defined above) between baseline and 12 months in both arms, at baseline and 12 months|Relative thickness as assessed by USG, The relative thickness will be used as given by the thickness of the most atrophic region related to the thickness of the reference region of the same patient (normal tissue). The change (increase) of the thickness is defined as difference between the relative thicknesses of the same atrophic region (given as percentage of the same reference region) at 6 months between both groups, at 6 months|Relative thickness as assessed by USG, The relative thickness will be used as given by the thickness of the most atrophic region related to the thickness of the reference region of the same patient (normal tissue). The change (increase) of the thickness is defined as difference between the relative thicknesses of the same atrophic region (given as percentage of the same reference region) at 6 months and 12 months in the control group, at 6 and 12 months|Relative thickness as assessed by USG, The relative thickness will be used as given by the thickness of the most atrophic region related to the thickness of the reference region of the same patient (normal tissue). The change (increase) of the thickness is defined as difference between the relative thicknesses of the same atrophic region (given as percentage of the same reference region) between baseline and 12 months in both groups, at baseline and 12 months|indicator dermatoses of Diabetes mellitus and associated autoimmune disorders of the skin, Comparison of dermatological findings between 6 and 12 months in the control Group. Dermatological outcome measures will consist in the detection and documentation of a) indicator dermatoses of diabetes mellitus (e. g. lipoatrophy, necrobiosis lipoidica, granuloma anulare), b) associated autoimmune disorders of the skin (e. g. vitiligo, lichen sclerosus, lichen ruber) and c) other, concurrent skin disorders such as atopic dermatitis, acne or psoriasis, for example. If available, disease scores such as the SCORAD score for atopic dermatitis or the PASI score for psoriasis vulgaris will be used to document disease activity., at 6 and 12 months|Number of new lipoatrophic areas, Occurrence of new lipoatrophic areas in both arms at 6 and 12 months, at 6 and 12 months|Glycemic control, Change of HbA1c at 6 and 12 months compared to baseline in both groups, at 6 and 12 months|Insulin requirements, Change of total daily insulin units per kg body weight at 6 and 12 months compared to baseline in both groups, at 6 and 12 months|Laboratory findings, Comparison of laboratory parameters (insulin antibodies, total IgE, specific insulin-IgE) between baseline, 6 months and 12 months, at baseline, 6 months and 12 months|Side effects, Side-effects of treatment with other insulins and insulin glulisine such as * severe hypoglycemia * DKA * Catheter occlusion * SAEs, within 12 months
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