Insulin Therapy in the Hospital Comparing Two Protocols

Study Overview
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Brief Summary
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The purpose of this study is to determine if by using insulin analog (Glargine and lispro insulin) with an insulin pen the investigators are able to obtain a higher rate of correct timing of insulin and food administration as when compared to the usual therapy (insulin NPH and regular) with syringes.

Official Title
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Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Glargine insulin
* Drug: NPH insulin and regular insulin
* Drug: lispro insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uncontrolled blood sugar: Random blood sugar ≥ 200mg/dl Pre-prandial blood sugar greater than 180 mg/dl on two occasions within 24 hours. Patient may be off insulin or on subcutaneous inpatient insulin regimen less than 36 hours. Transition from an Insulin Drip in the intensive care units to subcutaneous insulin upon transfer to general ward. Patient is able to eat and oral feeding is expected. Exclusion Criteria: Patients receiving inpatient oral hypoglycemic agents Patients with chronic kidney disease stages 4 & 5 (estimated GFR of <30ml/min) and on dialysis Patient with chronic liver disease Patient with hypoglycemia unawareness Pregnancy Patients who are on NPO for medical reasons. Patient is expected to stay in the hospital for less than 3 days. Patient on a new inpatient insulin regimen for > 36 hours.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: 2<br>The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the Inpatient Diabetes Advisory Group and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff. | Drug: NPH insulin and regular insulin<br>* The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the Inpatient Diabetes Advisory Group and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.<br>|
| Experimental: 1<br>The study group will receive Insulin Glargine as basal insulin and bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of insulin pen/syringe on the food tray) by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the Inpatient Diabetes Advisory Group and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff | Drug: Glargine insulin<br>* The study group will receive Insulin Glargine as basal insulin. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the Inpatient Diabetes Advisory Group and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.<br>* Other names: Lantus insulin;Drug: lispro insulin<br>* Bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of insulin pen/syringe on the food tray) by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the Inpatient Diabetes Advisory Group and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of correct timing of insulin and food administration |  | Correct time was 30 min before to 30 minutes after meal was given for control group, and 15 minutes before to 15 minutes after in case group | 
| Pre and post- prandial glucose levels |  | Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge | 
| Nursing staff satisfaction scores for evaluation of the two methods |  | 24 hours after last patient is discharged | 
| Hypoglycemia rates. |  | From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial | 
| High excursions of blood sugars (>300 mg/dl). |  | From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Inpatient, Insulin, Insulin pen