Type 1 Diabetes Mellitus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGFiasp®
Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
DRUGNovolog®
Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
DEVICE670G hybrid closed loop continuous subcutaneous insulin infusion system
CSII
Sponsors
Texas Diabetes & Endocrinology, P.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial 2. Male or female, age ≥18 years at the time of signing informed consent 3. Documented diagnoses of T1DM ≥1 year prior to the day of screening 4. Using the Medtronic pump Minimed 670G for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least 30 days prior to screening and willing to continue using their personal Medtronic Minimed 670G and CSII for insulin treatment throughout the trial. 5. Ability and willingness to use the same insulin infusion sets throughout the trial 6. Using the same insulin for at least 30 days prior to screening 7. HbA1c \< 8.5% as assessed by local laboratory at screening 8. BMI ≤ 35.0 kg/m2 at screening 9. Ability and willingness to adhere to the protocol including performing SMPG profiles, attending visits, utilizing the auto mode feature of the pump for at least 80 % of the time during the study, and completing meal tests
Exclusion criteria
1. Known or suspected hypersensitivity to trial products or related products 2. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) 3. Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies 4. Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial 5. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the past 180 days prior to the day of screening 6. Subjects classified as being in New York Heart Association (NYHA) Class IV at screening 7. Planned coronary, carotid or peripheral artery revascularization known on the day of screening. 8. Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic ≥180 mmHg or diastolic ≥110 mmHg) at screening 9. Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening 10. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of \< 45 ml/min/1.73 m2 11. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism in the opinion of the Investigator 12. Proliferative retinopathy or maculopathy requiring acute treatment at the time of screening 13. History of hospitalization for ketoacidosis ≤180 days prior to the day of screening 14. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 30 days before screening 15. Presence of malignant neoplasms at the time of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed. 16. Reoccurring Severe hypoglycemia while on the Medtronic Minimed 670G in the investigators opinion 17. Any condition which, in the opinion of the Investigator, might jeopardize Subject's safety or compliance with the protocol \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-Hour Change in Postprandial Plasma Glucose (PPG) | 6th week of therapy | Change was calculated as the PPG value at 1 hour minus the PPG value at baseline (time -2 minutes) during meal test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time Spent Between Below 70 mg/dL | Weeks 1 through 6, Weeks 8 through 13 | 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) |
| Percentage of Time Spent Between 70 mg/dL and 180 mg/dL | Weeks 1 through 6, Weeks 8 through 13 | 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) |
| Percentage of Time Spent Above 200 mg/dL | Weeks 1 through 6, Weeks 8 through 13 | 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) |
| Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL) | Weeks 1 through 6, Weeks 8 through 13 | 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) |
| Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL) | Weeks 1 through 6, Weeks 8 through 13 | 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) |
| 1,5 Anhydroglucitol Levels | Week 6, Week 13 | 1,5 anhydroglucitol levels were measured on the 6th week of each therapy |
| Fructosamine Levels | Week 6, Week 13 | Cumulative glycemic control expressed in fructosamine levels (micromol/Liter) were measured on the 6th week of each therapy |
| HbA1c | Week 6, Week 13 | Cumulative glycemic control expressed in HbA1c% measured on the 6th week of each therapy |
| Insulin Use - Change in Daily Dose | Weeks 1 through 6, Weeks 8 through 13 | Change was calculated as the value on the last day of therapy minus the value on the 1st day of therapy in each period |
| 2-Hour Change in Postprandial Plasma Glucose (PPG) | 6th week of therapy | Change was calculated as the value at 2 hour minus the value at baseline during meal test |
| Insulin Use - Basal | Weeks 1 through 6, Weeks 8 through 13 | 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 |
| Insulin Use - Automatic Basal Insulin | Weeks 1 through 6, Weeks 8 through 13 | Average amount per day (units) calculated for each participant under each therapy |
| Insulin Pump - Active Insulin Time | Weeks 1 through 6, Weeks 8 through 13 | Average time per day (hours) calculated for each participant under each therapy |
| Insulin Pump - Auto Mode | Weeks 3 through 6, Weeks 10 through 13 | Percentage of time spent in auto-mode after calibration under each therapy |
| Insulin Pump - Manual Mode | Weeks 3 through 6, Weeks 10 through 13 | Percentage of time spent in manual-mode after calibration under each therapy |
| Change in Carbohydrate Ratio | Weeks 1 through 6, Weeks 8 through 13 | 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 |
| Infusion Site Reactions | 14 week treatment period | Number of Infusion site reactions reported by patient |
| Pump Occlusions | 14 week treatment period | Number of Occlusion events reported by patient |
| Insulin Use - Bolus | Weeks 1 through 6, Weeks 8 through 13 | 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 |
Countries
United States
Participant flow
Recruitment details
45 patients were screened for eligibility between June 11,2019 and November 21, 2019 at a diabetes clinic in Austin, TX
Pre-assignment details
40 of 45 participants were randomized. All 5 who were not randomized did not meet inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Fiasp/Novolog 7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion
Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII | 20 |
| Novolog/Fiasp 7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion
Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII | 17 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Treatment | Lost to Follow-up | 0 | 3 |
Baseline characteristics
| Characteristic | Total | Novolog/Fiasp | Fiasp/Novolog |
|---|---|---|---|
| Age, Continuous | 45.7 years STANDARD_DEVIATION 27.1 | 43.8 years STANDARD_DEVIATION 12.77 | 47.2 years STANDARD_DEVIATION 13.17 |
| BMI | 27.1 kg/m^2 STANDARD_DEVIATION 3.41 | 27.3 kg/m^2 STANDARD_DEVIATION 3.15 | 26.9 kg/m^2 STANDARD_DEVIATION 3.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 16 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 173.4 cm STANDARD_DEVIATION 9.29 | 174.6 cm STANDARD_DEVIATION 7.22 | 172.3 cm STANDARD_DEVIATION 10.82 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 37 Participants | 17 Participants | 20 Participants |
| Region of Enrollment United States | 37 participants | 17 participants | 20 participants |
| Sex: Female, Male Female | 12 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 25 Participants | 13 Participants | 12 Participants |
| Weight | 81.7 kg STANDARD_DEVIATION 13.61 | 83.3 kg STANDARD_DEVIATION 12.45 | 80.3 kg STANDARD_DEVIATION 14.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 18 |
| other Total, other adverse events | 11 / 19 | 7 / 18 |
| serious Total, serious adverse events | 1 / 19 | 0 / 18 |
Outcome results
Primary
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
Population: All patients who participated in the meal test after 6 weeks of therapy in each arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | 1-Hour Change in Postprandial Plasma Glucose (PPG) | Fiasp | 105.15 mg/dL | Standard Deviation 56.73 |
| Fiasp/Novolog | 1-Hour Change in Postprandial Plasma Glucose (PPG) | NovoLog | 99.90 mg/dL | Standard Deviation 82.7 |
| Novolog/Fiasp | 1-Hour Change in Postprandial Plasma Glucose (PPG) | Fiasp | 154.24 mg/dL | Standard Deviation 54.25 |
| Novolog/Fiasp | 1-Hour Change in Postprandial Plasma Glucose (PPG) | NovoLog | 114.94 mg/dL | Standard Deviation 61.14 |
Comparison: Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.p-value: 0.00895% CI: [7.88, 48.4]Mixed Models Analysis
Secondary
1,5 Anhydroglucitol Levels
1,5 anhydroglucitol levels were measured on the 6th week of each therapy
Time frame: Week 6, Week 13
Population: All patients who participated in the meal test after 6 weeks of therapy in each period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | 1,5 Anhydroglucitol Levels | Fiasp | 6.50 µg/mL | Standard Deviation 3.37 |
| Fiasp/Novolog | 1,5 Anhydroglucitol Levels | NovoLog | 6.28 µg/mL | Standard Deviation 3.54 |
| Novolog/Fiasp | 1,5 Anhydroglucitol Levels | Fiasp | 7.12 µg/mL | Standard Deviation 3.23 |
| Novolog/Fiasp | 1,5 Anhydroglucitol Levels | NovoLog | 6.95 µg/mL | Standard Deviation 3.31 |
Comparison: Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.p-value: 0.30395% CI: [-0.59, 0.16]Mixed Models Analysis
Secondary
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
Population: All patients who participated in the meal test after 6 weeks of therapy in each arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | 2-Hour Change in Postprandial Plasma Glucose (PPG) | Fiasp | 72.55 mg/dL | Standard Error 90.62 |
| Fiasp/Novolog | 2-Hour Change in Postprandial Plasma Glucose (PPG) | NovoLog | 69.10 mg/dL | Standard Error 92.55 |
| Novolog/Fiasp | 2-Hour Change in Postprandial Plasma Glucose (PPG) | Fiasp | 65.00 mg/dL | Standard Error 57.22 |
| Novolog/Fiasp | 2-Hour Change in Postprandial Plasma Glucose (PPG) | NovoLog | 104.53 mg/dL | Standard Error 80.57 |
Comparison: Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.p-value: 0.13695% CI: [-5.42, 39.46]Mixed Models Analysis
Secondary
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
Population: All patients who participated in the meal test after 6 weeks of therapy in each arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Change in Carbohydrate Ratio | Fiasp | -.27 I:CR | Standard Deviation 1.09 |
| Fiasp/Novolog | Change in Carbohydrate Ratio | NovoLog | -.14 I:CR | Standard Deviation 0.95 |
| Novolog/Fiasp | Change in Carbohydrate Ratio | Fiasp | -.02 I:CR | Standard Deviation 0.47 |
| Novolog/Fiasp | Change in Carbohydrate Ratio | NovoLog | .2 I:CR | Standard Deviation 0.76 |
Secondary
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
Population: All patients who participated in the meal test after 6 weeks of therapy in each period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Fructosamine Levels | Fiasp | 322.60 mcmol/L | Standard Deviation 42.24 |
| Fiasp/Novolog | Fructosamine Levels | NovoLog | 305.40 mcmol/L | Standard Deviation 32.28 |
| Novolog/Fiasp | Fructosamine Levels | Fiasp | 296.35 mcmol/L | Standard Deviation 31.1 |
| Novolog/Fiasp | Fructosamine Levels | NovoLog | 314.31 mcmol/L | Standard Deviation 28.97 |
Comparison: Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.p-value: 0.96895% CI: [-10.32, 9.99]Mixed Models Analysis
Secondary
HbA1c
Cumulative glycemic control expressed in HbA1c% measured on the 6th week of each therapy
Time frame: Week 6, Week 13
Population: All patients who participated in the meal test after 6 weeks of therapy in each period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | HbA1c | Fiasp | 7.09 HbA1c% | Standard Deviation 0.47 |
| Fiasp/Novolog | HbA1c | NovoLog | 7.09 HbA1c% | Standard Deviation 0.44 |
| Novolog/Fiasp | HbA1c | Fiasp | 7.00 HbA1c% | Standard Deviation 0.31 |
| Novolog/Fiasp | HbA1c | NovoLog | 6.88 HbA1c% | Standard Deviation 0.33 |
Comparison: Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.p-value: 0.05995% CI: [-0.13, 0]Mixed Models Analysis
Secondary
Infusion Site Reactions
Number of Infusion site reactions reported by patient
Time frame: 14 week treatment period
Population: All patients who participated in the meal test after 6 weeks of therapy in each arm
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fiasp/Novolog | Infusion Site Reactions | Fiasp | 0 occurances |
| Fiasp/Novolog | Infusion Site Reactions | NovoLog | 3 occurances |
| Novolog/Fiasp | Infusion Site Reactions | Fiasp | 1 occurances |
| Novolog/Fiasp | Infusion Site Reactions | NovoLog | 2 occurances |
Secondary
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
Population: All patients who participated in the meal test after 6 weeks of therapy in each arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Insulin Pump - Active Insulin Time | Fiasp | 3 hours | Standard Deviation 0.06 |
| Fiasp/Novolog | Insulin Pump - Active Insulin Time | NovoLog | 3 hours | Standard Deviation 0 |
| Novolog/Fiasp | Insulin Pump - Active Insulin Time | Fiasp | 3 hours | Standard Deviation 0 |
| Novolog/Fiasp | Insulin Pump - Active Insulin Time | NovoLog | 3 hours | Standard Deviation 0.02 |
Secondary
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
Population: All patients who participated in the meal test after 6 weeks of therapy in each arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Insulin Pump - Auto Mode | Fiasp | 89.28 percentage of time | Standard Deviation 6.42 |
| Fiasp/Novolog | Insulin Pump - Auto Mode | NovoLog | 86.17 percentage of time | Standard Deviation 11.43 |
| Novolog/Fiasp | Insulin Pump - Auto Mode | Fiasp | 89.31 percentage of time | Standard Deviation 8.42 |
| Novolog/Fiasp | Insulin Pump - Auto Mode | NovoLog | 87.2 percentage of time | Standard Deviation 15.6 |
Secondary
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
Population: All patients who participated in the meal test after 6 weeks of therapy in each arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Insulin Pump - Manual Mode | Fiasp | 10.72 percentage of time | Standard Deviation 6.42 |
| Fiasp/Novolog | Insulin Pump - Manual Mode | NovoLog | 13.45 percentage of time | Standard Deviation 11.44 |
| Novolog/Fiasp | Insulin Pump - Manual Mode | Fiasp | 10.69 percentage of time | Standard Deviation 8.42 |
| Novolog/Fiasp | Insulin Pump - Manual Mode | NovoLog | 12.8 percentage of time | Standard Deviation 15.6 |
Secondary
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
Population: All patients who participated in the meal test after 6 weeks of therapy in each arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Insulin Use - Automatic Basal Insulin | Fiasp | .87 units | Standard Deviation 0.307 |
| Fiasp/Novolog | Insulin Use - Automatic Basal Insulin | NovoLog | .86 units | Standard Deviation 0.32 |
| Novolog/Fiasp | Insulin Use - Automatic Basal Insulin | Fiasp | 1.20 units | Standard Deviation 0.65 |
| Novolog/Fiasp | Insulin Use - Automatic Basal Insulin | NovoLog | 1.20 units | Standard Deviation 0.66 |
Secondary
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
Population: All patients who participated in the meal test after 6 weeks of therapy in each arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Insulin Use - Basal | Fiasp | 1.54 percentage of units | Standard Deviation 6.54 |
| Fiasp/Novolog | Insulin Use - Basal | NovoLog | -1.83 percentage of units | Standard Deviation 7.62 |
| Novolog/Fiasp | Insulin Use - Basal | Fiasp | 4.32 percentage of units | Standard Deviation 7.85 |
| Novolog/Fiasp | Insulin Use - Basal | NovoLog | 1.34 percentage of units | Standard Deviation 5.35 |
Secondary
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
Population: All patients who participated in the meal test after 6 weeks of therapy in each arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Insulin Use - Bolus | NovoLog | 1.83 percentage of units | Standard Deviation 7.62 |
| Fiasp/Novolog | Insulin Use - Bolus | Fiasp | -1.54 percentage of units | Standard Deviation 6.54 |
| Novolog/Fiasp | Insulin Use - Bolus | Fiasp | -4.32 percentage of units | Standard Deviation 7.85 |
| Novolog/Fiasp | Insulin Use - Bolus | NovoLog | -1.34 percentage of units | Standard Deviation 5.35 |
Secondary
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
Population: All patients who participated in the meal test after 6 weeks of therapy in each arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Insulin Use - Change in Daily Dose | Fiasp | -2.1 units | Standard Deviation 7.45 |
| Fiasp/Novolog | Insulin Use - Change in Daily Dose | NovoLog | 1.10 units | Standard Deviation 11.8 |
| Novolog/Fiasp | Insulin Use - Change in Daily Dose | Fiasp | .29 units | Standard Deviation 13.35 |
| Novolog/Fiasp | Insulin Use - Change in Daily Dose | NovoLog | -2.65 units | Standard Deviation 9.13 |
Secondary
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
Population: All patients for whom continuous glucose monitoring data was available during the specified time periods
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Percentage of Time Spent Above 200 mg/dL | Fiasp | 14.90 percentage of time | Standard Deviation 6.9 |
| Fiasp/Novolog | Percentage of Time Spent Above 200 mg/dL | NovoLog | 18.57 percentage of time | Standard Deviation 7.85 |
| Novolog/Fiasp | Percentage of Time Spent Above 200 mg/dL | Fiasp | 15.44 percentage of time | Standard Deviation 5.65 |
| Novolog/Fiasp | Percentage of Time Spent Above 200 mg/dL | NovoLog | 14.11 percentage of time | Standard Deviation 4.43 |
Comparison: Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.p-value: 0.04595% CI: [0.04, 2.32]Mixed Models Analysis
Secondary
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
Population: All patients for whom continuous glucose monitoring data was available during the specified time periods
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Percentage of Time Spent Between 70 mg/dL and 180 mg/dL | NovoLog | 70.28 percentage of time | Standard Deviation 8.12 |
| Fiasp/Novolog | Percentage of Time Spent Between 70 mg/dL and 180 mg/dL | Fiasp | 74.80 percentage of time | Standard Deviation 8.08 |
| Novolog/Fiasp | Percentage of Time Spent Between 70 mg/dL and 180 mg/dL | Fiasp | 73.67 percentage of time | Standard Deviation 6.8 |
| Novolog/Fiasp | Percentage of Time Spent Between 70 mg/dL and 180 mg/dL | NovoLog | 75.04 percentage of time | Standard Deviation 5.95 |
Comparison: Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.p-value: 0.01695% CI: [-2.84, -0.31]Mixed Models Analysis
Secondary
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
Population: All patients for whom continuous glucose monitoring data was available during the specified time periods
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Percentage of Time Spent Between Below 70 mg/dL | Fiasp | 1.94 percentage of time | Standard Deviation 1.48 |
| Fiasp/Novolog | Percentage of Time Spent Between Below 70 mg/dL | NovoLog | 2.42 percentage of time | Standard Deviation 1.62 |
| Novolog/Fiasp | Percentage of Time Spent Between Below 70 mg/dL | Fiasp | 1.72 percentage of time | Standard Deviation 1.2 |
| Novolog/Fiasp | Percentage of Time Spent Between Below 70 mg/dL | NovoLog | 2.03 percentage of time | Standard Deviation 1.36 |
Comparison: Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.p-value: 0.02995% CI: [0.05, 0.73]Mixed Models Analysis
Secondary
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
Population: All patients for whom continuous glucose monitoring data was available during the specified time periods
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL) | Fiasp | .46 percentage of time | Standard Deviation 0.53 |
| Fiasp/Novolog | Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL) | NovoLog | .50 percentage of time | Standard Deviation 0.5 |
| Novolog/Fiasp | Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL) | Fiasp | .40 percentage of time | Standard Deviation 0.48 |
| Novolog/Fiasp | Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL) | NovoLog | .35 percentage of time | Standard Deviation 0.36 |
Secondary
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
Population: All patients for whom continuous glucose monitoring data was available during the specified time periods
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fiasp/Novolog | Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL) | Fiasp | 0 percentage of time | Standard Deviation 0 |
| Fiasp/Novolog | Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL) | NovoLog | 0 percentage of time | Standard Deviation 0 |
| Novolog/Fiasp | Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL) | Fiasp | 0 percentage of time | Standard Deviation 0 |
| Novolog/Fiasp | Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL) | NovoLog | 0 percentage of time | Standard Deviation 0 |
Secondary
Pump Occlusions
Number of Occlusion events reported by patient
Time frame: 14 week treatment period
Population: All patients who participated in the meal test after 6 weeks of therapy in each arm
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fiasp/Novolog | Pump Occlusions | Fiasp | 7 occurances |
| Fiasp/Novolog | Pump Occlusions | NovoLog | 7 occurances |
| Novolog/Fiasp | Pump Occlusions | Fiasp | 6 occurances |
| Novolog/Fiasp | Pump Occlusions | NovoLog | 9 occurances |