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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
235
Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.
Grady Memorial Hospital
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
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.
Time frame: up to 10 days
Mean Daily BG
Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG
Time frame: 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.
Time frame: 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
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
Length of Hospital Stay
Length of hospitalization
Time frame: 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
Time frame: 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
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
Pneumonia
Pneumonia (CDC criteria)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
Bacteremia
Bacteremia with SIRS/Sepsis
Time frame: 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
Time frame: 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 \[rise \>50% of baseline or creatinine \>2.5 mg/dl\]
Time frame: 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
Time frame: Participants will be followed over the hospital stay- expected 6 days.
Number of Subjects With BG > 300 mg/dL
Time frame: Subjects will be followed over the hospital stay: expected 6 days
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