Effectiveness of Adding Subcutaneous Long-acting Glargine to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy

Phase 1

Completed

• Conditions: Diabetes
• Interventions: Drug: Glargine

• Registration Number: NCT01153100
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The investigators anticipate that the use of Glargine 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: 2010-04
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre- and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutrition requiring insulin drip.
• Patients with type 1 and type 2 diabetes mellitus (DM) will be included.
• Patients with both types of diabetes will be among those treated with the insulin drip while being NPO, having severe concomitant illness or receiving enteral and parenteral nutrition.
• Patients will be of age 19 to 80.

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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 drip 2 weeks and longer, pregnancy, Lantus allergy, and concurrent sulfonamide treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin drip and glargine	Glargine	Insulin drip and glargine 0.25 units per kg body weight

Primary Outcome Measures

Name	Time	Method
Reduction in rebound hyperglycemia (blood glucose levels over 180 mg/dl)	within 48 hours of discontinuation

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