Diabetes
Conditions
Keywords
Diabetes
Brief summary
The investigators anticipate that the use of Detemir will decrease the duration of an insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin drip is discontinued.
Interventions
DRUGDetemir
Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Sponsors
Novo Nordisk A/S
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diabetic ketoacidosis (DKA) and hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre-and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutritional requiring insulin drip. * Patients with type 1 and type 2 diabetes mellitus (DM) will be included. * Patient with both types of diabetes will be among those treated with insulin drip while being NPO, having severe concomitant illness or receiving enteral and parenteral nutrition * Patients will be of age 19 to 80.
Exclusion criteria
* Inability to consent for the study for any reason including cognitive impairment secondary to hyperglycemia, presence of severe medical conditions requiring intubation, severe sepsis, hypothermia, and anticipated length of insulin drop 2 weeks and longer, pregnancy, Levemir allergy, and concurrent sulfonamide treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl) | within 48 hours of discontinuation | Number of participants exhibiting rebound hyperglycemia (blood glucose levels over 180 mg/dl) |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in Duration of Insulin Drip Therapy and Reduction in Total and Average Per Hour Insulin Drip Dose | within one week of insulin drip therapy |
| Reduction in ICU Length of Stay | within two weeks of hospitalization |
| Equal or Improved Diabetes Control | within two weeks of hospitalization |
| Reduction in Time to Get Back to Control of Glycemia (140-180 mg/dl) if Rebound Hyperglycemia Occurs | within one week post insulin drip |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Insulin Drip Therapy Continuous IV insulin infusion without added detemir | 14 |
| Insulin Drip and Detemir Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy | 16 |
| Total | 30 |
Baseline characteristics
| Characteristic | Standard Insulin Drip Therapy | Total | Insulin Drip and Detemir |
|---|---|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 11.2 | 53.26 years STANDARD_DEVIATION 14.36 | 54.1 years STANDARD_DEVIATION 16.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 25 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 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 | 11 Participants | 24 Participants | 13 Participants |
| Region of Enrollment United States | 14 participants | 30 participants | 16 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 11 Participants | 23 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 16 |
| other Total, other adverse events | 0 / 14 | 0 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 16 |
Outcome results
Primary
Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl)
Number of participants exhibiting rebound hyperglycemia (blood glucose levels over 180 mg/dl)
Time frame: within 48 hours of discontinuation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Insulin Drip Therapy | Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl) | 14 Participants |
| Insulin Drip and Detemir | Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl) | 3 Participants |
Secondary
Equal or Improved Diabetes Control
Time frame: within two weeks of hospitalization
Population: We have no information regarding whether this outcome measure was collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, this outcome measure cannot be reported.
Secondary
Reduction in Duration of Insulin Drip Therapy and Reduction in Total and Average Per Hour Insulin Drip Dose
Time frame: within one week of insulin drip therapy
Population: We have no information regarding whether this outcome measure was collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, this outcome measure cannot be reported.
Secondary
Reduction in ICU Length of Stay
Time frame: within two weeks of hospitalization
Population: We have no information regarding whether this outcome measure was collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, this outcome measure cannot be reported.
Secondary
Reduction in Time to Get Back to Control of Glycemia (140-180 mg/dl) if Rebound Hyperglycemia Occurs
Time frame: within one week post insulin drip
Population: We have no information regarding whether this outcome measure was collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, this outcome measure cannot be reported.