Hyperglycemia Clinical Trial
Official title:
Clinical Process Improvement With A Bedside Computerized Insulin Therapy Protocol For Blood Glucose Control (eProtocol-insulin) in Adult And Pediatric Intensive Care Unit Patients-Second Phase (Phase-2): Distribution and Implementation of Validated eProtocol-insulin in Naïve ICUs
The Purpose of this study is to:
1. Introduce the refined, validated, and safe computerized bedside decision support tool
for blood glucose management in critically ill adult and pediatric ICU patients that
was studied in Phase 1 into a second group of naïve ICUs, none of which participated in
eProtocol-insulin development, refinement or validation
2. Monitor how often low blood sugar levels occur during use of the bedside tool.
3. Determine how the computerized tool effects the workload of the ICU nurses.
In the current second phase of this project (Phase-2), we will introduce the refined,
validated, and safe eProtocol-insulin into a second group of naïve ICUs, none of which
participated in eProtocol-insulin development, refinement or validation. Our primary goal in
this second phase is to determine the feasibility of exporting this tool to naïve ICU
environments. In this second phase we will also compare the effects of the eProtocol-insulin
and ordinary care approaches to glucose control on the bedside nurse's experience.
This second phase will be a prospective cohort study. We will determine the feasibility of
distributing eProtocol-insulin and will further validate eProtocol-insulin in >4 adult and
>4 pediatric ICUs. If necessary we will modify eProtocol-insulin with an iterative
refinement process, with Institutional Review Board (IRB) and independent Data and Safety
Monitoring Board (DSMB) oversight. eProtocol-insulin will be considered refined if >90% of
the instructions are accepted and if the percent of glucose values between 70 and 110 mg/dl
(3.9-6.1 mMol/L) are equivalent to our Phase-1 refinement and validation experience of 46%%,
and if the rate of glucose values < 40 mg/dl (2.2 mMol/l) is less than 0.5% of glucose
measurements.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01267448 -
Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia
|
Phase 4 | |
| Recruiting |
NCT03775733 -
Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia
|
N/A | |
| Completed |
NCT03482154 -
Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
|
||
| Active, not recruiting |
NCT05477368 -
Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes
|
N/A | |
| Completed |
NCT03675360 -
Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
|
N/A | |
| Completed |
NCT00535600 -
Effects of Bariatric Surgery on Insulin
|
||
| Not yet recruiting |
NCT06159543 -
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
|
N/A | |
| Recruiting |
NCT02885922 -
The Effects of add-on Anti-diabetic Drugs in Type 2 Diabetic Patients
|
||
| Recruiting |
NCT02885909 -
Inpatient Blood Glucose Control in Taichung Veterans General Hospital
|
Phase 4 | |
| Withdrawn |
NCT01488383 -
Effect of Stevioside in Postpandrial Glucose in Healthy Adults
|
N/A | |
| Completed |
NCT02012465 -
Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Patients
|
Early Phase 1 | |
| Completed |
NCT01805414 -
Breakfast Nutrition and Inpatient Glycemia
|
N/A | |
| Completed |
NCT01803568 -
Skeletal Muscles, Myokines and Glucose Metabolism MYOGLU
|
N/A | |
| Completed |
NCT01810952 -
The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients
|
Phase 4 | |
| Active, not recruiting |
NCT01247714 -
Clinical Evaluation of a Specific Enteral Diet for Diabetics
|
N/A | |
| Not yet recruiting |
NCT00846144 -
The Reduction in Glucose Stimulated Insulin Secretion Induced by Cytokines May be Prevented by Copper Addition - Studies in Diabetic Patients
|
N/A | |
| Completed |
NCT00996099 -
Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients
|
N/A | |
| Completed |
NCT00468494 -
Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia?
|
N/A | |
| Completed |
NCT00394407 -
Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT00515723 -
Glucose and Lipid Metabolism on Antipsychotic Medication
|
N/A |