Diabetes Mellitus
Conditions
Keywords
diabetes, hyperglycemia, open heart surgery, cardiothoracic surgery, detemir, insulin infusion, intravenous insulin
Brief summary
In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).
Detailed description
High sugar (glucose) is common after surgery, even in patients who do not have diabetes. High glucose contributes to severe hospital complications and even death. Insulin infusions appear to reduce this risk, but are generally only continued for a few days after surgery. In this study, we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir). 90 patients who have undergone recent open heart surgery and are requiring an insulin infusion will be enrolled. They will be randomly assigned to one of three doses of detemir, which consists of 50%, 65%, or 80% of the total daily insulin infusion requirement in the fasting state. Subjects will also receive identical mealtime coverage according to the amount of carbohydrate (glucose) that is ingested. It is expected that the high dose group will achieve superior glycemic control without excessive hypoglycemia.
Interventions
DRUGDetemir
Detemir dosed at 50% of calculated basal insulin infusion requirements
Sponsors
Novo Nordisk A/S
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* diabetes mellitus * post-cardiothoracic surgery * requiring an insulin infusion of at least 1 unit/hour * Age 18-75
Exclusion criteria
* Glucocorticoids * total parenteral nutrition (TPN) or tube feeds * Pregnancy * Surgical procedures in the next 48 hours for whom intravenous (IV) insulin will be expected * Expected length of stay less than 48 hours following cessation of the insulin drip * Patients using subcutaneous insulin pumps * Diabetic ketoacidosis * End-stage renal disease * End-stage liver disease * Coma * Potentially sensitive admissions: prisoners, human immunodeficiency virus(HIV), suicidality * Unable to give consent in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 | day 2, day 3 | Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Hypoglycemia (Defined as Glucose <65 mg/dl) | 48 hours | Number of patients with hypoglycemia (defined as glucose \<65 mg/dl) |
| Reversion to Intravenous Insulin for Failure of Glycemic Control | 72 hours | Number of participants who went back on intravenous insulin for failure of glycemic control. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 50% Conversion Factor Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily | 28 |
| 65% Conversion Factor Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily | 29 |
| 80% Conversion Factor Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily | 25 |
| Total | 82 |
Baseline characteristics
| Characteristic | 65% Conversion Factor | 80% Conversion Factor | 50% Conversion Factor | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 6 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 19 Participants | 22 Participants | 65 Participants |
| Age Continuous | 57 years STANDARD_DEVIATION 9.1 | 61 years STANDARD_DEVIATION 7.6 | 58 years STANDARD_DEVIATION 8 | 58.7 years STANDARD_DEVIATION 8.4 |
| Region of Enrollment United States | 29 participants | 25 participants | 28 participants | 82 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 5 Participants | 17 Participants |
| Sex: Female, Male Male | 25 Participants | 17 Participants | 23 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 29 | 1 / 25 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 | 1 / 25 |
Outcome results
Primary
Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3
Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3
Time frame: day 2, day 3
Population: intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 50% Conversion Factor | Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 | 10 participants |
| 65% Conversion Factor | Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 | 18 participants |
| 80% Conversion Factor | Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 | 14 participants |
Secondary
Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)
Number of patients with hypoglycemia (defined as glucose \<65 mg/dl)
Time frame: 48 hours
Population: Intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 50% Conversion Factor | Patients With Hypoglycemia (Defined as Glucose <65 mg/dl) | 0 participants |
| 65% Conversion Factor | Patients With Hypoglycemia (Defined as Glucose <65 mg/dl) | 6 participants |
| 80% Conversion Factor | Patients With Hypoglycemia (Defined as Glucose <65 mg/dl) | 3 participants |
Secondary
Reversion to Intravenous Insulin for Failure of Glycemic Control
Number of participants who went back on intravenous insulin for failure of glycemic control.
Time frame: 72 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 50% Conversion Factor | Reversion to Intravenous Insulin for Failure of Glycemic Control | 2 participants |
| 65% Conversion Factor | Reversion to Intravenous Insulin for Failure of Glycemic Control | 0 participants |
| 80% Conversion Factor | Reversion to Intravenous Insulin for Failure of Glycemic Control | 1 participants |