Please select the eligibility criteria that correspond to the clinical trial below.
Title: Benefits of Point-of-Care Glucose Testing and Insulin Supplementation at Bedtime in Insulin Treated Patients With Type 2 Diabetes
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.


Options:
A: Inclusion Criteria:

* Males or females between the ages of 18 and 75 years admitted to a general medicine or surgical services.
* A known history of type 2 diabetes mellitus \> 3 months, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (sulfonylureas, meglitinides, metformin, thiazolidinediones, dipeptidyl peptidase (DPP) IV inhibitors).
* Patients admitted for non-cardiac elective or emergency surgery or trauma.
* Subjects must have an admission BG \> 140 mg and \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate \< 18 milliequivalent /L, potential hydrogen (pH) \< 7.30, or positive serum or urinary ketones).

Exclusion Criteria:

* Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
* Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria \[32\].
* Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU.
* Patients admitted for coronary artery bypass graft (CABG) or patients receiving continuous insulin infusion.
* Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.0 mg/dl).
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
* Female subjects are pregnant or breast feeding at time of enrollment into the study.
* Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
* Female subjects are pregnant or breast feeding at time of enrollment into the study.
B: Inclusion Criteria:

1. Male and female patients with a known history of T2DM for \> 3 months
2. Age 18-80 years
3. Home treatment with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy
4. BG \> 140 mg and \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis

Exclusion Criteria:

1. Hyperglycemia without a history of diabetes
2. Acute critical illness admitted to the ICU or expected to require ICU admission
3. Receiving continuous insulin infusion
4. Clinically relevant hepatic disease
5. Patients on corticosteroid therapy
6. Patients with creatinine ≥ 3.5 mg/dl
7. Subjects unable to sign consent
8. Pregnancy
C: Inclusion Criteria:

1. Males or females between the ages of 18 and 70 years admitted to a general medicine service.
2. A known history of type 2 diabetes mellitus \> 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
3. Subjects must have an admission blood glucose \> 140 mg and \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate \< 18 mEq/L or positive serum or urinary ketones).

Exclusion Criteria:

1. Subjects with increased blood glucose concentration, but without a known history of diabetes.
2. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria \[57\].
3. Patients with known HIV, acute critical or surgical illness and/or expected to require admission to a critical care unit (ICU, CCU), corticosteroid therapy, or to undergo surgery during the hospitalization course.
4. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥3.0.
5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
6. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
7. Female subjects are pregnant or breast feeding at time of enrollment into the study.
D: Inclusion Criteria:

1. Males or females between the ages of 18 and 80 years admitted to a general surgery service.
2. Patients admitted for non-cardiac elective or emergency surgery or trauma.
3. A known history of type 2 diabetes mellitus \> 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
4. Subjects must have an admission blood glucose \> 140 mg and \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate \< 18 mEq/L or positive serum or urinary ketones).

Exclusion Criteria:

1. Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
2. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria.
3. Acute critical illness or CABG surgery expected to require prolonged admission to a critical care unit (ICU, CCU, SICU, Neuro ICU).
4. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥ 3.5 mg/dl.
5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
6. Female subjects are pregnant or breast feeding at time of enrollment into the study.

Answer: B