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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 insulin glargine and Novolog | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin glargine | Drug | 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% |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 days |
| Percent of Time Spent in Glycemic Range of 70-140 mg/dL |
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Inclusion criteria
English-speaking
Males and female adult subjects admitted to Boston Medical Center to a medical or surgical floor.
Consultation by the Inpatient Diabetes Service at Boston Medical Center is required prior to consent.
Age ≥ 21 and <= 80 years.
Diagnosed with type 2 diabetes at least 180 days prior to screening.
Hyperglycemia during admission, as defined by a point of care and/or venous blood glucose ≥ 140 mg/dL.
Prior to admission subjects must be using one of the following for outpatient diabetes management:
Patients who are expected to remain hospitalized for a minimum of 48 hours following CGM sensor placement.
BMI <45 kg/m^2.
Subjects must have insulin glargine dosing planned at bedtime for the duration of the study period. Morning and afternoon dosing of insulin glargine are exclusionary.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara M Alexanian, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40067436 | Derived | Alexanian SM, Cheney MC, Bello Ramos JC, Spartano NL, Wolpert HA, Steenkamp DW. Impact of Meal Insulin Bolus Timing and Bedtime Snacking on Continuous Glucose Monitoring-Derived Glycemic Metrics in Hospitalized Inpatients. Diabetes Technol Ther. 2025 Jul;27(7):511-516. doi: 10.1089/dia.2025.0027. Epub 2025 Mar 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed at Least 4 Meals |
|
| |||||||||||||||||||||
| Insulin Boluses & Postprandial CGM Data |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Mean | Standard Deviation | percentage of time in range (TIR) | 3 days |
|
During subject participation, on average 3 days
Collected during the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| transfer to higher level of care | General disorders | Systematic Assessment | After enrollment but before receiving any study medication pt became clinically worse and was transferred to a higher level of care. Subject was immediately discontinued from the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding at CGM site | Blood and lymphatic system disorders | Systematic Assessment | pt experienced bleeding at CGM site, sensor was removed and subject was discontinued from the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara M Alexanian, MD | Boston Medical Center | 617-638-8545 | sara.alexanian@bmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2022 | Dec 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
|
| NovoLog | Drug | 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. |
|
|
| Insulin Fiasp | Drug | 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 | Other | Standard carbohydrate diet as per usual hospital care (75g with each meal) |
|
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. |
| 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. | 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 | 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. | 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. | 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. | 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. | 4 hours postprandial |
| Nutrition method changed |
|
| Transfer to ICU |
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| Bleeding at CGM site |
|
| NOT COMPLETED |
|
|
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetes treatment prior to admission | Count of Participants | Participants |
|
| OG001 | 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) |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of time in range (TIR) | 3 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of time in range (TIR) | 3 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of time in range (TIR) | 3 days |
|
|
|
| Secondary | 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 | 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. | Posted | Mean | Standard Deviation | percentage of time in range (TIR) | 3 days |
|
|
|
| Secondary | 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. | Patients with adequate overnight CGM data for analysis | Posted | Mean | Standard Deviation | percent time in range | 3 days |
|
|
|
| Secondary | 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. | There were 110 participants (57 in the Novolog arm and 53 in the Fiasp arm) with 4-hour postprandial data available for analysis | Posted | Mean | Standard Deviation | percentage of time in range (TIR) | 4 hours postprandial |
|
|
|
| Secondary | 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. | There were 110 participants (57 in the Novolog arm and 53 in the Fiasp arm) with 4-hour postprandial data available for analysis | Posted | Mean | Standard Deviation | percentage of time in range (TIR) | 4 hours postprandial |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of time in range (TIR) | 4 hours postprandial |
|
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | 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) | 0 | 61 | 1 | 61 | 1 | 61 |
|
|
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |
| BG <40 dL/mg |
|
| <40 |
|
| BG <40 mg/dL |
|