This is an exploratory, single-center, randomized, open label, active-controlled, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoLog® when used in the Medtronic MiniMed 670G system in subjects with T1DM.
This study is being performed to compare Fiasp® in terms of glycemic control with a focus on post-prandial 1-hour plasma glucose level and system-based outcomes to NovoLog® insulin when used in the Medtronic mini Med 670G HCL system (operating in auto-mode) in patients with type 1 diabetes. The investigator's hypothesis is that post prandial glucoses will be lower and time in range will be greater during the Fiasp® treatment period. Subjects will have a 2 week screening period, 14 week treatment period and 30 Day follow up period. After at least 7 weeks on treatment period one they will crossover to treatment period two on the opposite treatment for 7 additional weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Texas Diabetes & Endocrinology
Austin, Texas, United States
1-Hour Change in Postprandial Plasma Glucose (PPG)
Change was calculated as the PPG value at 1 hour minus the PPG value at baseline (time -2 minutes) during meal test
Time frame: 6th week of therapy
2-Hour Change in Postprandial Plasma Glucose (PPG)
Change was calculated as the value at 2 hour minus the value at baseline during meal test
Time frame: 6th week of therapy
Percentage of Time Spent Between Below 70 mg/dL
Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)
Time frame: Weeks 1 through 6, Weeks 8 through 13
Percentage of Time Spent Between 70 mg/dL and 180 mg/dL
Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)
Time frame: Weeks 1 through 6, Weeks 8 through 13
Percentage of Time Spent Above 200 mg/dL
Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)
Time frame: Weeks 1 through 6, Weeks 8 through 13
Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL)
Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)
Time frame: Weeks 1 through 6, Weeks 8 through 13
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Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL)
Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)
Time frame: Weeks 1 through 6, Weeks 8 through 13
1,5 Anhydroglucitol Levels
1,5 anhydroglucitol levels were measured on the 6th week of each therapy
Time frame: Week 6, Week 13
Fructosamine Levels
Cumulative glycemic control expressed in fructosamine levels (micromol/Liter) were measured on the 6th week of each therapy
Time frame: Week 6, Week 13
HbA1c
Cumulative glycemic control expressed in HbA1c% measured on the 6th week of each therapy
Time frame: Week 6, Week 13
Insulin Use - Change in Daily Dose
Change was calculated as the value on the last day of therapy minus the value on the 1st day of therapy in each period
Time frame: Weeks 1 through 6, Weeks 8 through 13
Insulin Use - Bolus
Change in %bolus insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period
Time frame: Weeks 1 through 6, Weeks 8 through 13
Insulin Use - Basal
Change in %basal insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period
Time frame: Weeks 1 through 6, Weeks 8 through 13
Insulin Use - Automatic Basal Insulin
Average amount per day (units) calculated for each participant under each therapy
Time frame: Weeks 1 through 6, Weeks 8 through 13
Insulin Pump - Active Insulin Time
Average time per day (hours) calculated for each participant under each therapy
Time frame: Weeks 1 through 6, Weeks 8 through 13
Insulin Pump - Auto Mode
Percentage of time spent in auto-mode after calibration under each therapy
Time frame: Weeks 3 through 6, Weeks 10 through 13
Insulin Pump - Manual Mode
Percentage of time spent in manual-mode after calibration under each therapy
Time frame: Weeks 3 through 6, Weeks 10 through 13
Change in Carbohydrate Ratio
Change was calculated as the carbohydrate ratio on the last day of therapy minus the carbohydrate ratio on the 1st day of therapy in each period
Time frame: Weeks 1 through 6, Weeks 8 through 13
Infusion Site Reactions
Number of Infusion site reactions reported by patient
Time frame: 14 week treatment period
Pump Occlusions
Number of Occlusion events reported by patient
Time frame: 14 week treatment period