Effectiveness of Adding Subcutaneous Long-Acting Detemir to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Drug: Detemir

• Registration Number: NCT01186003
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-19
• Study First Posted: 2010-08-20
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2021-11
• Results First Submitted: 2021-11-08
• Results First Submitted QC: 2021-11-08
• Last Update Submitted: 2021-11-08
• Results First Posted: 2021-12-07
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin drip and Detemir	Detemir	Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States