Prevention of Skin Problems With Diabetes Devices in Pediatric Patients
Condition: Type 1 Diabetes; Dermatologic Complication
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      A Cluster-controlled Intervention Trial regarding Prevention of Dermatological Complications
      towards use of Continuous glucose monitoring and insulin pumps in pediatric patients with
      Type 1 Diabetes. The patients will be followed prospectively with visits every 3rd month for
      the first year of initiation of device. Besides a standardized treatment plan if
      dermatological complications evolve, will be used.
    

Detailed description: 
      Background Unfortunately it has been shown earlier that dermatological complications are a
      huge challenge towards treatment with CSII and CGM in children. A preceding cross-sectional
      study in Danish patients showed that 90% of the 143 pediatric patients using CSII had
      experienced dermatological complications. Of those more than 60% currently had visible skin
      reaction due to the CSII. Dermatological complications to CSII were associated to atopic
      diseases and use of pump treatment for a longer period. For patients using CGM, 80% reported
      dermatological complications to the treatment, the most frequent being itching affecting more
      than 70%. Furthermore, 46% had at least one site with skin reaction due to CGM.

      In the future, the use of artificial pancreas with closed-loop systems will still be
      dependent on the use of patches to fasten infu-sion sets and sensors. This skin complications
      poses a major challenge that must be investigated to reduce the overall burden of this
      chronic disease. The investigators have conducted a focus group study, which has given new
      insight into the perception of dermatological complications and further in-depth
      understanding of potential disease mechanisms regarding development of dermatological
      complications. No studies exist relating to prevention, consequences and treatment of
      dermatological complications in the setting of adhesive systems in T1D treatment.

      Risk factors for development of dermatological complications are not well-known yet.
      Therefore, the investigators aim to create a possibly preventive screening tool based on a
      prospective study to guide future clinicians in whom patients are in risk of dermatological
      complications during use of CSII and CGM. This could help in guidance of which patients to
      give more information, preventive treatment or a more skin-sensitive CSII/CGM-system.

      The hypothesis is that intensive information and proper skin care prior and during the
      initiation of CSII and CGM use, can reduce the dermatological

      Study design This study is a prospective longitudinal study and will be the first
      longitudinal study concerning dermato-logical complications in a T1D population. It is a
      trial based on experience from pre-ceding cross-sectional study. The study is also a
      cluster-controlled intervention trial and will be the first interventional study regarding
      dermatological complications too. The intervention consists of intensive information about
      dermatological complications and possible preventive actions with skin moisturizing use. The
      cluster-controlling will include clusters defined by all patients from same de-partment.
      Patients enrolled from Herlev and Gentofte University Hospital will constitute the
      intervention group. Besides, a subgroup of the intervention group will be randomized to the
      ultrasound-skin-sites-intervention.

      Justification for study design:

      Dermatological complications construct a major challenge in diabetes technology especially
      among children and adolescents. To identify the modifiable or non-modifiable risk factors a
      prospective longitudinal study-design must be carried out. The longitudinal study-design will
      be combined with the interventional study to make the most of participants effort since the
      participants anyway will be investigated the first 12 months of their use of CSII and/or
      CGM/FGM. The interventional design could give important information regarding the possible
      effects of proper information and support regarding dermatological skin care and
      complications. And hopefully this could be a cheap way to reduce the dermatological
      complications.
    

Intervention name(s): Skin Care Program
Intervention type(s): Combination Product
Intervention description(s): The intervention consists of a Skin Care Program including neat information regarding dermatological complications to the device use, prevention of these and moisturizer to keep healthy skin.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Type 1 Diabetes