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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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The purpose of this study is to determine whether aggressive (goal pre-prandial blood glucose <110 mg/dl) versus conservative (goal pre-prandial blood glucose <180mg/dl) diabetes treatment of type 2 diabetic patients on the general medical wards has any effect on hospital outcomes.
Objective: The objective of this study is to determine the effect of an "aggressive" blood glucose control (goal pre-prandial CBG <110 mg/dl) versus a "conservative" blood glucose control (goal pre-prandial CBG <180 mg/dl) on length of stay in hospitalized type 2 diabetic patients using levemir (detemir) and novolog (aspart) insulins.
Study Site: Parkland Memorial Hospital, 5201 Harry Hines Blvd, Dallas, Texas 75235. Parkland Hospital is a 720 adult bed public hospital that serves as the main teaching hospital for the University of Texas-Southwestern Medical Center. In addition, Parkland Memorial Hospital possesses the University Diabetes Treatment Center, an eleven bed medical ward devoted to inpatient diabetes management. This study will be conducted throughout all of Parkland's general medical floors, including the University Diabetes Treatment Center.
Patient Population: The population for this study includes men and women with type 2 diabetes admitted to the general medicine wards of Parkland Memorial Hospital.
Study Design and Duration: This is a single-center, randomized, single blind, non-inferiority study design.
Patients admitted to Parkland Hospital with type 2 diabetes will be recruited to the study within 24 hours of admission. Gravid patients, patients in DKA, or HHS will be excluded. All patients will be evaluated for inclusion and exclusion criteria. During the hospitalization, patients will be stratified by age and admitting diagnosis and randomized to either an "aggressive" blood glucose control (goal pre-prandial CBG <110 mg/dl) or a "conservative" blood glucose control (goal pre-prandial CBG <180 mg/dl). Subcutaneous detemir and novolog will be employed according to the enclosed protocol to meet the goal blood glucose level. The insulin will be administered by nursing staff via the FlexPen, a pre-filled pen-like insulin delivery device. CBGs will be obtained before breakfast, before lunch, before supper, and at bedtime. If a patient is NPO, then the CBGs will be obtained at the time that the patient was to have eaten.
Treatment of the patient's primary admitting diagnosis including plan and procedures will be completely at the primary team's discretion.
Should a patient require transfer to an intensive care unit or to a telemetry unit, then the patient's participation in the study will be held until discharge from said unit. While the patient is in an ICU or telemetry unit, the blood glucose goal and management will be completely decided upon by the primary team.
The study will terminate at the end of the hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative Blood Glucose Control | Active Comparator | Goal Pre-prandial blood glucose <180 mg/dl. |
|
| Aggressive Blood Glucose Control | Active Comparator | Pre-prandial goal blood glucose <110 mg/dl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levemir (Detemir) and Novolog (Aspart) Insulin | Drug | Will use individualized doses of levemir (detemir) and novolog (aspart) insulin to reach blood glucose goal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospitalization Stay | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of Hospitalization | 18 months | |
| All-Cause Mortality | 18 months | |
| Frequency of Hypoglycemic Episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Fordan, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| John Richard, MD | University of Texas Southwestern Medical Center | Study Director |
| Philip Raskin, MD | University of Texas Southwestern Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Memorial Hospital | Dallas | Texas | 75235 | United States |
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| Label | URL |
|---|---|
| UT Southwestern Clinical Trials | View source |
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|
| 18 months |
| Rate of Transfer to Telemetry Unity | 18 months |
| Rate of Nosocomial Infections | 18 months |
| Rate of Surgical Procedures | 18 months |
| Rate of Re-hospitalization | 18 months |
| Time to goal blood glucose level | 18 months |
| Time to becoming medically stable for discharge | 18 months |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| D061267 | Insulin Aspart |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |
| D011384 | Proinsulin |
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