Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus

Phase 3

Completed

Conditions: Type 2 Diabetes Treated With Insulin

Interventions: Drug: Insulin glargine
Drug: Insulin Fiasp
Drug: NovoLog
Other: Standard carbohydrate diet

Registration Number: NCT04460326

Lead Sponsor: Boston Medical Center

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 137

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 insulin glargine and Novolog	Standard carbohydrate diet	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.
Group 2 insulin glargine and Fiasp	Standard carbohydrate diet	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.
Group 2 insulin glargine and Fiasp	Insulin 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.
Group 1 insulin glargine and Novolog	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.
Group 1 insulin glargine and Novolog	Insulin glargine	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.
Group 2 insulin glargine and Fiasp	Insulin glargine	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.

Primary Outcome Measures

Name	Time	Method
Postprandial Glucose Control	3 days	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.

Secondary Outcome Measures

Name	Time	Method
Glycemic Control While Hospitalized	3 days	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.
Percent of Time Spent in Glycemic Range of 70-140 mg/dL	3 days	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.
Percent of Nocturnal Time in Glycemic Target Range 100-180 mg/dL	3 days	The percent of nocturnal time (from 00.01 AM to 5:59 AM) in the glycemic target range of 100-180 mg/dL
Percent of Time Spent With Hypoglycemia During Hospitalization	3 days	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.
Percent of Nocturnal Time Spent With Hypoglycemia	3 days	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.
Percent of Postprandial Time Spent With Level 1 Hyperglycemia	4 hours postprandial	The percent of time spent in level 1 hyperglycemia (181-239 mg/dL) will be assessed using CGM in the 4 hour postprandial period.
Percent of Postprandial Time Spent With Level 2 Hyperglycemia	4 hours postprandial	The percent of time spent in level 2 hyperglycemia (\>240 mg/dL) will be assessed using CGM in the 4 hour postprandial period.
Percent of Postprandial Time Spent With Hypoglycemia	4 hours postprandial	The percent of postprandial time in three categories of hypoglycemia will be assessed: \<70 mg/dL, \<54 mg/dL, and \<40 mg/dL.