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Clinical Trial Details

Trial ID: L3095
Source ID: NCT03594565
Associated Drug: Fluticasone Propionate
Title: 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
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: T1DM|Hypersensitivity
Interventions: DRUG: Fluticasone Propionate
Outcome Measures: Primary: Difference in skin irritation before and after regular application of nsFP according to the modified Draize scale., Erythema and edema were assessed for adhesive and sensor-insertion areas on a 4-point scale, with total score ≤3 defined as mild, 4-5 as moderate, and 6-8 as severe., 2 years from patient first enrollment | Secondary: Change in BMI SDS, Weight (kg), height (meters), age (years) and sex will be combined to report BMI SDS, 6 months after nsFP use|Change in height SDS 6 months after nsFP use, Height (meters), age (years) and sex will be combined to report height SDS, 6 months after nsFP use.|Change in mean glucose 6 months after nsFP use, Mean glucose measured as mg/dl, 6 months after nsFP use.|Change in glycated hemoglobin 6 months after nsFP use, Glycated hemoglobin measured with the DCCT (Diabetes Control and Complications Trial) units, presented as percentage The new mmols/mol values are known as the IFCC (International Federation of Clinical Chemistry) units., 6 months after nsFP use.
Sponsor/Collaborators: Sponsor: Assaf-Harofeh Medical Center
Gender: ALL
Age: CHILD, ADULT
Phases: EARLY_PHASE1
Enrollment: 13
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2016-03
Completion Date: 2018-06
Results First Posted:
Last Update Posted: 2019-08-13
Locations:
URL: https://clinicaltrials.gov/show/NCT03594565