Glucose, Blood
Conditions
Keywords
Insulin, Blood Glucose
Brief summary
Insulin infusions are commonly used in hospitalized diabetics to control blood sugar, and they are effective. However, insulin infusions require the use of limited resources. Insulin infusions are therefore changed to insulin shots as a patient recovers. Once an insulin infusion is stopped and shots are started, blood sugar control is harder to maintain. This is, in part, because physicians have different ideas on how to dose insulin shots in hospitalized patients. A math equation has been developed by the research staff that attempts to predict the effective doses of insulin shots in patients whose insulin infusion have just been stopped. The math equation was developed for patients with type 2 diabetes mellitus. In this study, all patients will be treated with the same type of insulin shots, with doses of the insulin shots chosen either by the math equation or by the judgment of the patient's physician. The study will then follow blood sugar values for 24 hours to see if the math equation is effective. If the equation is proven to be effective, a new tool will exist for physicians to determine the best dose of insulin shots for type 2 diabetics. Such a tool would, in turn, allow for widespread use of insulin infusions to determine a patient's insulin needs before discharge from the hospital. Blood sugar control for type 2 diabetics that are inpatient or outpatient would improve as a result, with potentially far reaching public health benefits.
Interventions
OTHERIICE Dosing
Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given.
OTHERHealthcare Provider dosing
Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Inpatients at an urban, mixed academic and community tertiary care hospital who were on IV insulin were enrolled. * Patients were taken from medical, general surgical, and cardiothoracic services, and were located both inside and outside the intensive care unit (ICU).
Exclusion criteria
* At time of enrollment, patients with type I diabetes mellitus, * active acute or chronic pancreatitis, * history of pancreatic surgery, * use of a self-titratable insulin pump, or * history of β-islet cell transplantation were excluded. * At time of randomization, patients with insulin drip rates ≤ 2 units/hr, ∆ in serum creatinine of \> 20% in previous 24 hours, or * those without caloric intake while on IV insulin were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Blood Glucose Values Within 80-140 mg/dL | Within 24 hours after cessation of IV insulin | Fingerstick glucose measurements were obtained up to six times for each participant. Percentage of blood glucose values within the target range of 80-140 mg/dL |
Secondary
| Measure | Time frame |
|---|---|
| Hypoglycemia (Serum Blood Glucose < 70 mg/dL) | Within 24 hours after cessation of IV insulin |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled between April 2008 to February 2009.
Pre-assignment details
78 subjects consented. 3 subjects excluded at screening. Of the 75 subjects remaining, only 57 subjects seen by the principal investigator (PI) because the patient's healthcare provider had to call the PI right before the intravenous insulin infusion (III) was discontinued. PI excluded 26 more subjects at III cessation--31 subjects randomized.
Participants by arm
| Arm | Count |
|---|---|
| Insulin Infusion Conversion Equation Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.
IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given. | 14 |
| Control Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.
Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given. | 17 |
| Total | 31 |
Baseline characteristics
| Characteristic | Insulin Infusion Conversion Equation | Control | Total |
|---|---|---|---|
| Age, Customized Age > 18 years old | 14 participants | 17 participants | 31 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 10 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 7 Participants | 12 Participants |
| Region of Enrollment United States | 14 participants | 17 participants | 31 participants |
| Sex/Gender, Customized Unknown | 14 participants | 17 participants | 31 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 17 |
| serious Total, serious adverse events | 0 / 14 | 0 / 17 |
Outcome results
Primary
Percentage of Blood Glucose Values Within 80-140 mg/dL
Fingerstick glucose measurements were obtained up to six times for each participant. Percentage of blood glucose values within the target range of 80-140 mg/dL
Time frame: Within 24 hours after cessation of IV insulin
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Infusion Conversion Equation | Percentage of Blood Glucose Values Within 80-140 mg/dL | 54.8 percentage of blood glucose values |
| Control | Percentage of Blood Glucose Values Within 80-140 mg/dL | 21.2 percentage of blood glucose values |
Secondary
Hypoglycemia (Serum Blood Glucose < 70 mg/dL)
Time frame: Within 24 hours after cessation of IV insulin