Point-of-Care Glucose Testing and Insulin Supplementation



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:1/5/2018
Start Date:May 2012
End Date:December 2013

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

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.

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.

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
We found this trial at
2
sites
80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Atlanta, GA
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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from
Atlanta, GA
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