The Use of Topical Nasal Steroids for Skin Reactions to Continuous Glucose Monitoring System, Among Children and Youth With Type 1 Diabetes Mellitus: Case Series
Condition: T1DM; Hypersensitivity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypersensitivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Background Type 1 diabetes mellitus is a chronic metabolic disorder that presents a
      significant set of challenges to the patient, their family and the physician. Near
      normoglycemia is associated with a reduced risk of microvascular and macrovascular
      complications in type 1 diabetes mellitus but is difficult to achieve despite considerable
      effort from patients and healthcare providers . Furthermore, episodes of hypoglycemia are
      frequent and may endanger life acutely. Subcutaneous glucose monitoring systems (CGMS), also
      called sensors that continuously measure interstitial fluid glucose levels have become
      available recently, and approved for use in children. CGMS has made it possible to assess the
      patterns and trends of blood glucose and the substantial variability in glucose excursions in
      the population of type 1 diabetes, and to prevent severe hypoglycemic episodes. The benefits
      of this technology are most apparent with near continuous wear of the sensors and is
      incorporated into the day to day management of the individual's diabetes . These devices
      provide patients with information regarding postprandial and overnight glucose profiles that
      are rarely, if ever, obtained with conventional self monitoring of blood glucose using home
      glucose meters .

      Skin reactions CGM systems measure the glucose content of interstitial fluid , using an
      electrochemical enzymatic sensor, which is accessed by a needle sensor inserted
      subcutaneously. The CGMS is compromised of a disposable subcutaneous glucose-sensing catheter
      connected by a cable to a pager sized glucose monitor . Problems related associated to skin
      irritation and sensor adhesiveness in these young children presents challenges to daily use
      of the CGMS. In the study conducted by Englert et al, for the Diabetes Research in Children
      (Directnet) Study Group - three primary factors that contributed to reduced CGM use were
      identified: the limited body surface area in smaller children, ambient temperature and
      humidity, as well as the type and duration of physical activity. A study conducted in Israel,
      by our group, demonstrated only 30% consistant use of the system, partly due to skin
      reactions . In our cohort, thirty participants of the CGMS group (36.1 %) had signs of local
      reaction to the RT-CGMS insertion. Mild-to severe local redness was reported in 19 % of
      patients and hyperpigmentation in 17 %. Skin reactions were among the reasons for
      discontinuation of CGMS (2/51 participants, 3.9 %).

      The use of Local Fluticasone for dermatological use Fluticasone propionate - the first
      carbothioate corticosteroid - has been classified as a potent anti-inflammatory drug for
      dermatological use. It is available as cream and ointment formulations for the acute and
      maintenance treatment of patients with dermatological disorders such as atopic dermatitis,
      psoriasis and vitiligo. This glucocorticoid is characterized by high lipophilicity, high
      glucocorticoid receptor binding and activation, and a rapid metabolic turnover in skin.
      Several clinical trials demonstrate a low potential for cutaneous and systemic side-effects .
      Even among paediatric patients with atopic dermatitis, fluticasone propionate proved to be
      safe and effective. These pharmacological and clinical properties are reflected by the high
      therapeutic index of this glucocorticoid. The same drug is also available as a nasal spray
      ,for cases of allergic rhinitis.

      The use of fluticasone in spray, sprayed on the location of CGMS insertion, prior to
      insertion to prevent adverse skin reactions in patients with type 1 DM using CGMS devices has
      not been addressed in the literature.

      Hypothesis :

      Minimizing skin irritation may significantly improve duration of use and tolerability of CGM
      devices by young children, as well a in young adults. The Investigators assumed that the
      simple use of a spray, which will not decrease the adhesiveness of the sensor, may improve
      use .

      Methods Children whose parents had difficulty with CGMS due to irritation, redness were
      offered to use Flixonase (FLUTICASONE PROPIONATE), with an approval form 29ג, indicating it
      is not approved for this specific diagnosis .

      The investigators followed those patients for improvement and possible local side effects.

      Study population Every patient, treated by the pediatric and adolescents diabetes mellitus
      interdisciplinary service , Assaf Haroffe Medical Center , who experienced local reaction at
      the site of CGMS was offered this medical option .

      Charts were reviewed for response . total participants - 15
    


Intervention name(s): Fluticasone Propionate
Intervention type(s): Drug
Intervention description(s): Local Fluticasone Propionate use prior to continuous glucose monitoring system insertion
Intervention MeSH terms: Fluticasone; Xhance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention