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

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of a Subcutaneously Administered Long-acting Insulin Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Glargine


Participation Criteria
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Eligibility Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard insulin drip therapy<br>Standard insulin drip therapy | |
| Active Comparator: Insulin drip and glargine<br>Insulin drip and glargine 0.25 units per kg body weight | Drug: Glargine<br>* Glargine 0.25 units per kg body weight given every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy<br>* Other names: Lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in rebound hyperglycemia (blood glucose levels over 180 mg/dl) |  | within 48 hours of discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes