Point-of-Care Glucose Testing and Insulin Supplementation

Study Overview
=================
Brief Summary
-----------------
Capillary point-of-care (POC) testing is advocated as a valuable aid in the management of diabetes and hyperglycemia in the hospital setting. POC testing aims at collecting information on BG levels at different time points during the day in order to assess glycemic control and to guide insulin adjustment/correction doses. Although POC testing provides insights into day-to-day excursions in BG levels, bedtime BG testing triggers the use of insulin supplements that may result in increased frequency of hypoglycemia and is expensive with an estimated annual cost in hospitals of several hundreds of millions of dollars in the U.S. Accordingly, this pilot study aims to assess the utility of POC and insulin supplementation (correction doses) at bedtime in improving glycemic control and in preventing hypoglycemia in non-ICU patients with type 2 diabetes mellitus (T2DM). A total of 250 non-ICU medical and surgical patients treated with basal bolus regimen will undergo POC testing before meals and bedtime (standard of care) and half of the patients will receive insulin correction doses at bedtime for BG > 140 mg/dL following a sliding scale protocol, while the other half will be followed without insulin supplementation at bedtime except for extreme hyperglycemia (BG > 350 mg/dl). Patients will be recruited at Emory University Hospital and Grady Memorial Hospital.

Detailed Description
-----------------
The value of POC testing and use of insulin supplements (correction doses) in particular at bedtime, has not been prospectively evaluated in insulin-treated patients with T2DM. In the non-ICU setting, practice guidelines for the management of hyperglycemia in patients with T2DM favor the use of physiologic (basal-nutritional-correction dose) insulin regimens over sliding scale regular insulin. POC testing is invasive and painful, and has the limitation of providing glycemic profile that is an incomplete picture of BG excursions and is not always an accurate method to monitor glucose compared to laboratory assays in addition to the major expense in health care delivery. The overall objective of this proposal is to conduct the first prospective randomized controlled trial (RCT) to determine the POC glucose testing and use of insulin supplementation at bedtime in improving glycemic control and in preventing hypoglycemia in insulin-treated non-ICU patients with T2DM. The central hypothesis of this proposal is that routine BG measurement and insulin supplementation at bedtime does not improve glycemic control or reduce frequency of hypoglycemia in insulin treated medicine and surgery patients with T2DM.

Official Title
-----------------
Benefits of Point-of-Care Glucose Testing and Insulin Supplementation at Bedtime in Insulin Treated Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: Bedtime insulin Aspart (Novolog)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients with a known history of T2DM for > 3 months Age 18-80 years Home treatment with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis Exclusion Criteria: Hyperglycemia without a history of diabetes Acute critical illness admitted to the ICU or expected to require ICU admission Receiving continuous insulin infusion Clinically relevant hepatic disease Patients on corticosteroid therapy Patients with creatinine ≥ 3.5 mg/dl Subjects unable to sign consent Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: Bedtime supplementation<br>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. | Drug: Bedtime insulin Aspart (Novolog)<br>* Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.<br>* Other names: Aspart (Novolog);|
| No Intervention: no bedtime supplementation<br>Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Fasting Blood Glucose | The primary outcome of the study is to compare differences in mean fasting blood glucose levels between patients receiving insulin supplements at bedtime compared to those without insulin supplementation. | up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Daily BG | Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG | participants will be followed for the duration of hospital stay, an expected average of 6 days | 
| Number of Hypoglycemia (BG < 70 mg/dl) | Secondary outcomes include the number of hypoglycemia (BG < 70 mg/dl) among both the groups. | participants will be followed for the duration of hospital stay, an expected average of 6 days | 
| Daily Dose of Insulin | Compare the daily dose of insulin used among both groups | participants will be followed for the duration of hospital stay, an expected average of 6 days | 
| Length of Hospital Stay | Length of hospitalization | participants will be followed for the duration of hospital stay, an expected average of 6 days | 
| Hospital Mortality | Mortality is defined as death occurring during admission or during the hospital stay | participants will be followed for the duration of hospital stay, an expected average of 6 days | 
| Nosocomial Infections (CDC) | Nosocomial infections during hospital stay as per the CDC criteria | participants will be followed for the duration of hospital stay, an expected average of 6 days | 
| Pneumonia | Pneumonia (CDC criteria) | participants will be followed for the duration of hospital stay, an expected average of 6 days | 
| Bacteremia | Bacteremia with SIRS/Sepsis | participants will be followed for the duration of hospital stay, an expected average of 6 days | 
| Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days | Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg | daily while in hospital for up to 10 days | 
| Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl] | Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl] | participants will be followed for the duration of hospital stay, an expected average of 6 days | 
| Number of BG Within Target | Number of glucose levels within target of 70-140 mg/dl | Participants will be followed over the hospital stay- expected 6 days. | 
| Number of Subjects With BG > 300 mg/dL |  | Subjects will be followed over the hospital stay: expected 6 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Point of care testing, Hypoglycemia, Basal bolus insulin