Hyperglycemia affects 30-40% of hospitalized patients. Despite the fact that basal/bolus insulin therapy has been demonstrated to improve glycemic control and clinical outcomes in patients, achieving good glucose control remains a challenge. This study examines the effects of Fiasp (a faster acting insulin) on blood sugars after meals compared to another type of insulin known as Novolog. The study will be performed in patients with type 2 diabetes admitted to the hospital, who are not in the intensive care unit, and who are being seen by the inpatient diabetes consult team. Eligible participants will be treated with Fiasp or Novolog injected multiple times a day before meals and at bedtime, in addition to a once daily injection of insulin glargine as basal insulin. Which type of meal time insulin (Fiasp vs Novolog) the subject gets is decided by chance, like the flip of a coin. Insulin doses will be started and titrated based on a protocol. All the subjects will wear a blinded continuous glucose monitoring (CGM)) sensor placed in their arm which they will wear for 72 hours during the study. The glucose values from the CGM, collected during the time it is worn, will be downloaded and compared to assess the response to the two different types of insulins - Fiasp and Novolog. The goal is to determine if Fiasp works as well as or better than Novolog in controlling blood sugars, particularly after meals, in the subjects of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
137
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 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.
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 as per usual hospital care (75g with each meal)
Boston Medical Center
Boston, Massachusetts, United States
Postprandial Glucose Control
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.
Time frame: 3 days
Glycemic Control While Hospitalized
Percent 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.
Time frame: 3 days
Percent of Time Spent in Glycemic Range of 70-140 mg/dL
Percent 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.
Time frame: 3 days
Percent of Time Spent With Hypoglycemia During Hospitalization
The 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.
Time frame: 3 days
Percent of Nocturnal Time in Glycemic Target Range 100-180 mg/dL
The percent of nocturnal time (from 00.01 AM to 5:59 AM) in the glycemic target range of 100-180 mg/dL
Time frame: 3 days
Percent of Nocturnal Time Spent With Hypoglycemia
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.
Time frame: 3 days
Percent of Postprandial Time Spent With Level 1 Hyperglycemia
The percent of time spent in level 1 hyperglycemia (181-239 mg/dL) will be assessed using CGM in the 4 hour postprandial period.
Time frame: 4 hours postprandial
Percent of Postprandial Time Spent With Level 2 Hyperglycemia
The percent of time spent in level 2 hyperglycemia (\>240 mg/dL) will be assessed using CGM in the 4 hour postprandial period.
Time frame: 4 hours postprandial
Percent of Postprandial Time Spent With Hypoglycemia
The percent of postprandial time in three categories of hypoglycemia will be assessed: \<70 mg/dL, \<54 mg/dL, and \<40 mg/dL.
Time frame: 4 hours postprandial
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