Trial Outcomes & Findings for Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus (NCT NCT04460326)
NCT ID: NCT04460326
Last Updated: 2024-03-19
Results Overview
Percent of time spent in the glycemic target range of 100-180 mg/dL in the 4 hour postprandial period will be assessed using a continuous glucose monitoring (CGM) system.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
137 participants
Primary outcome timeframe
3 days
Results posted on
2024-03-19
Participant Flow
Participant milestones
| Measure |
Group 1 Insulin Glargine and Novolog
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
|---|---|---|
|
Completed at Least 4 Meals
STARTED
|
68
|
69
|
|
Completed at Least 4 Meals
COMPLETED
|
61
|
61
|
|
Completed at Least 4 Meals
NOT COMPLETED
|
7
|
8
|
|
Insulin Boluses & Postprandial CGM Data
STARTED
|
61
|
61
|
|
Insulin Boluses & Postprandial CGM Data
COMPLETED
|
56
|
49
|
|
Insulin Boluses & Postprandial CGM Data
NOT COMPLETED
|
5
|
12
|
Reasons for withdrawal
| Measure |
Group 1 Insulin Glargine and Novolog
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
|---|---|---|
|
Completed at Least 4 Meals
Early discharge
|
5
|
5
|
|
Completed at Least 4 Meals
Started oral antihyperglycemic
|
1
|
1
|
|
Completed at Least 4 Meals
Nutrition method changed
|
1
|
0
|
|
Completed at Least 4 Meals
Transfer to ICU
|
0
|
1
|
|
Completed at Least 4 Meals
Bleeding at CGM site
|
0
|
1
|
|
Insulin Boluses & Postprandial CGM Data
Postprandial or CGM data not available
|
5
|
12
|
Baseline Characteristics
Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Group 1 Insulin Glargine and Novolog
n=68 Participants
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
n=69 Participants
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 12 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
58 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
69 participants
n=7 Participants
|
137 participants
n=5 Participants
|
|
Diabetes treatment prior to admission
Insulin use
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Diabetes treatment prior to admission
Non-insulin injectable agents
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Diabetes treatment prior to admission
Oral agents
|
45 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 daysPopulation: A total of 110 participants received at least 4 meal boluses and had adequate 4-hr CG data for analysis. Results presented as percentage time in range 100-180 mg/dL in the 4 hour postprandial period for each group
Percent of time spent in the glycemic target range of 100-180 mg/dL in the 4 hour postprandial period will be assessed using a continuous glucose monitoring (CGM) system.
Outcome measures
| Measure |
Group 1 Insulin Glargine and Novolog
n=57 Participants
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
n=53 Participants
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
|---|---|---|
|
Postprandial Glucose Control
|
36.18 percentage of time in range (TIR)
Standard Deviation 29.78
|
45.22 percentage of time in range (TIR)
Standard Deviation 32.63
|
SECONDARY outcome
Timeframe: 3 daysPercent of time spent in the glycemic target range of 100-180 mg/dL during the duration of the study will be assessed using a continuous glucose monitoring (CGM) system.
Outcome measures
| Measure |
Group 1 Insulin Glargine and Novolog
n=61 Participants
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
n=61 Participants
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
|---|---|---|
|
Glycemic Control While Hospitalized
|
34.9 percentage of time in range (TIR)
Standard Deviation 26.0
|
39.9 percentage of time in range (TIR)
Standard Deviation 26.6
|
SECONDARY outcome
Timeframe: 3 daysPercent of time spent in the glycemic target range of 70-140 mg/dL during the duration of the study assessed using a continuous glucose monitoring (CGM) system.
Outcome measures
| Measure |
Group 1 Insulin Glargine and Novolog
n=61 Participants
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
n=61 Participants
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
|---|---|---|
|
Percent of Time Spent in Glycemic Range of 70-140 mg/dL
|
16.9 percentage of time in range (TIR)
Standard Deviation 18.4
|
20.2 percentage of time in range (TIR)
Standard Deviation 21.3
|
SECONDARY outcome
Timeframe: 3 daysThe percent of time in three categories of hypoglycemia : \<70 mg/dL, \<54 mg/dL, and \<40 mg/dL will be assessed using a CGM during hospitalization.
Outcome measures
| Measure |
Group 1 Insulin Glargine and Novolog
n=61 Participants
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
n=61 Participants
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
|---|---|---|
|
Percent of Time Spent With Hypoglycemia During Hospitalization
BG <70 dL/mg
|
0.80 percentage of time in range (TIR)
Standard Deviation 2.1
|
1.52 percentage of time in range (TIR)
Standard Deviation 4.6
|
|
Percent of Time Spent With Hypoglycemia During Hospitalization
BG <54 dL/mg
|
0.16 percentage of time in range (TIR)
Standard Deviation 0.6
|
0.53 percentage of time in range (TIR)
Standard Deviation 1.7
|
|
Percent of Time Spent With Hypoglycemia During Hospitalization
BG <40 dL/mg
|
0.02 percentage of time in range (TIR)
Standard Deviation 0.08
|
0.10 percentage of time in range (TIR)
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: 3 daysPopulation: Only participants with 95% valid CGM data were included in this overnight analysis. This was a total of 108 participants- 56 in the Novolog group and 52 in the Fiasp group.
The percent of nocturnal time (from 00.01 AM to 5:59 AM) in the glycemic target range of 100-180 mg/dL
Outcome measures
| Measure |
Group 1 Insulin Glargine and Novolog
n=56 Participants
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
n=52 Participants
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
|---|---|---|
|
Percent of Nocturnal Time in Glycemic Target Range 100-180 mg/dL
|
36.7 percentage of time in range (TIR)
Standard Deviation 37.4
|
42.1 percentage of time in range (TIR)
Standard Deviation 40.7
|
SECONDARY outcome
Timeframe: 3 daysPopulation: Patients with adequate overnight CGM data for analysis
The percent of nocturnal time (from 00.01 AM to 5:59 AM) in three categories of hypoglycemia: \<70 mg/dL, \<54 mg/dL, and \<40 mg/dL will be assessed using CGM.
Outcome measures
| Measure |
Group 1 Insulin Glargine and Novolog
n=56 Participants
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
n=52 Participants
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
|---|---|---|
|
Percent of Nocturnal Time Spent With Hypoglycemia
<70 mg/dL
|
0.52 percent time in range
Standard Deviation 2.44
|
1.12 percent time in range
Standard Deviation 4.85
|
|
Percent of Nocturnal Time Spent With Hypoglycemia
<54 mg/dL
|
0.043 percent time in range
Standard Deviation 0.24
|
0.22 percent time in range
Standard Deviation 1.31
|
|
Percent of Nocturnal Time Spent With Hypoglycemia
<40
|
0 percent time in range
Standard Deviation 0
|
0.073 percent time in range
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 4 hours postprandialPopulation: There were 110 participants (57 in the Novolog arm and 53 in the Fiasp arm) with 4-hour postprandial data available for analysis
The percent of time spent in level 1 hyperglycemia (181-239 mg/dL) will be assessed using CGM in the 4 hour postprandial period.
Outcome measures
| Measure |
Group 1 Insulin Glargine and Novolog
n=57 Participants
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
n=53 Participants
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
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|---|---|---|
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Percent of Postprandial Time Spent With Level 1 Hyperglycemia
|
30.1 percentage of time in range (TIR)
Standard Deviation 16.9
|
23.3 percentage of time in range (TIR)
Standard Deviation 19.2
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SECONDARY outcome
Timeframe: 4 hours postprandialPopulation: There were 110 participants (57 in the Novolog arm and 53 in the Fiasp arm) with 4-hour postprandial data available for analysis
The percent of time spent in level 2 hyperglycemia (\>240 mg/dL) will be assessed using CGM in the 4 hour postprandial period.
Outcome measures
| Measure |
Group 1 Insulin Glargine and Novolog
n=57 Participants
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
n=53 Participants
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
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|---|---|---|
|
Percent of Postprandial Time Spent With Level 2 Hyperglycemia
|
30.3 percentage of time in range (TIR)
Standard Deviation 31.2
|
26.7 percentage of time in range (TIR)
Standard Deviation 31.2
|
SECONDARY outcome
Timeframe: 4 hours postprandialThe percent of postprandial time in three categories of hypoglycemia will be assessed: \<70 mg/dL, \<54 mg/dL, and \<40 mg/dL.
Outcome measures
| Measure |
Group 1 Insulin Glargine and Novolog
n=57 Participants
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
n=53 Participants
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
|---|---|---|
|
Percent of Postprandial Time Spent With Hypoglycemia
BG <70 mg/dL
|
0.70 percentage of time in range (TIR)
Standard Deviation 2.32
|
0.76 percentage of time in range (TIR)
Standard Deviation 3.37
|
|
Percent of Postprandial Time Spent With Hypoglycemia
BG <54 mg/dL
|
0.14 percentage of time in range (TIR)
Standard Deviation 0.85
|
012 percentage of time in range (TIR)
Standard Deviation 0.75
|
|
Percent of Postprandial Time Spent With Hypoglycemia
BG <40 mg/dL
|
0.01 percentage of time in range (TIR)
Standard Deviation 0.07
|
0.03 percentage of time in range (TIR)
Standard Deviation 0.19
|
Adverse Events
Group 1 Insulin Glargine and Novolog
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 Insulin Glargine and Fiasp
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 Insulin Glargine and Novolog
n=61 participants at risk
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
n=61 participants at risk
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
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|---|---|---|
|
General disorders
transfer to higher level of care
|
0.00%
0/61 • During subject participation, on average 3 days
Collected during the study
|
1.6%
1/61 • Number of events 1 • During subject participation, on average 3 days
Collected during the study
|
Other adverse events
| Measure |
Group 1 Insulin Glargine and Novolog
n=61 participants at risk
Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
NovoLog: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
Group 2 Insulin Glargine and Fiasp
n=61 participants at risk
Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
Insulin glargine: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10%
Insulin Fiasp: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
Standard carbohydrate diet: Standard carbohydrate diet as per usual hospital care (75g with each meal)
|
|---|---|---|
|
Blood and lymphatic system disorders
bleeding at CGM site
|
0.00%
0/61 • During subject participation, on average 3 days
Collected during the study
|
1.6%
1/61 • Number of events 1 • During subject participation, on average 3 days
Collected during the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place