The purpose of this study is to investigate whether a zinc-free insulin is an effective treatment option for lipoatrophy in patients with type 1 Diabetes (T1D) and insulin pump (CSII, continuous subcutaneous insulin infusion) therapy.
Randomized, controlled, open-label parallel study. Clinical Study Phase IV After being included in the study, subjects are getting an extensive dermatological examination by a pediatric dermatologist familiar with cutaneous complications of T1D, additionally pathological results will be documented by photography and, if necessary, videodermoscopy. Additionally, an evaluation of their lipoatrophic areas using imaging methods like ultrasound (USG) and MRI will be performed. After randomization, half of the included children switch their pump insulin into insulin glulisine (intervention group) for 6 months. The others continue their current treatment (control group) and switch to insulin glulisine 6 months later. Both groups are followed-up until month 12. Hence, after the 4th visit at 6 months, all enrolled patients are on insulin glulisine pumps for a further period of 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Half of patients with lipoatrophy will be switched randomly to insulin Apidra for 12 months. Any site other than the lipoatrophic site would be used for delivering the insulin for the purpose of this study.
Half of patients with lipoatrophy will still use their current Insulin for 6 months. After 6 months the current insulin will be switched to insulin Apidra for the next 6 months.
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.
Time frame: at 6 months
Relative thickness as assessed by MRI
Change of relative thickness (as defined above) at 6 and 12 months in the control group
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 6 and 12 months
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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
Time frame: 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.
Time frame: at 6 and 12 months
Number of new lipoatrophic areas
Occurrence of new lipoatrophic areas in both arms at 6 and 12 months
Time frame: at 6 and 12 months
Glycemic control
Change of HbA1c at 6 and 12 months compared to baseline in both groups
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: within 12 months