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Clinical Trial Details

Trial ID: L5246
Source ID: NCT04414579
Associated Drug: Faster Insulin Aspart (Fiasp®)
Title: The Efficacy and Safety of Faster Insulin Aspart (Fiasp®) Compared to Conventional Insulin Aspart (NovoLog®) as Correction Bolus
Acronym: PLATEAU
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Faster Insulin Aspart (Fiasp®)
Outcome Measures: Primary: Time to stabilization of rising blood sugar by CGM after correction bolus, Time (in minutes) to stabilization of rising blood sugar (GPP) by CGM after correction bolus during the final 2 week maintenance period. Two categories of correction dose will be analyzed: 1) those following an isolated correction dose (taken independently of a meal dose), and 2) those taken as part of a combination bolus with a meal dose., 2 weeks | Secondary: Incidence of early hypoglycemia, Incidence of early hypoglycemia (Blood glucose \< 54 mg/dl within 1 and 2 hours) following correction bolus with each insulin (Key Safety Endpoint), 25 weeks|Change in Insulin Sensitivity Factor, Change in Insulin Sensitivity Factor, if any, required for hypoglycemia prevention using Fiasp as recorded by continuous subcutaneous insulin infusion device setting report, 25 weeks|Change in Insulin On Board, Change in Insulin On Board, if any, required for prevention of late hyperglycemia using Fiasp as recorded by continuous subcutaneous insulin infusion device setting report, 25 weeks|GlycoMark differences between arms, GlycoMark (1,5 anhydroglucitol, a marker of postprandial glucose excursion) during use of each insulin., 25 weeks|HbA1c differences between arms, HbA1c during use of each insulin, 25 weeks|Percent time spent in target range, hyperglycemic range, and hypoglycemic range, Percent time spent in target range, hyperglycemic range and hypoglycemic range by Continuous Glucose Monitoring (CGM) on each insulin during the final 2 weeks of each treatment period. Target ranges include 70-180 mg/dL. Hyperglycemia ranges to be captured will include Category 1: 181-250 mg/dL and Category 2: above 250 mg/dL. Hypoglycemia ranges to be captured include Category 1: 69-54 mg/dL and Category 2: below 54 mg/dL., 4 weeks|Standard deviation differences between arms, Standard deviation of mean blood glucose as determined by CGM on each insulin, 4 weeks|Treatment related impact measures between arms, Treatment related impact measures on each insulin using TRIM D questionnaire, 6 weeks
Sponsor/Collaborators: Sponsor: Mountain Diabetes and Endocrine Center
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 45
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-03-27
Completion Date: 2021-03
Results First Posted:
Last Update Posted: 2020-11-24
Locations: Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
URL: https://clinicaltrials.gov/show/NCT04414579