Point-of-Care Glucose Testing and Insulin Supplementation
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

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.
    

Intervention name(s): Bedtime insulin Aspart (Novolog)
Intervention type(s): Drug
Intervention description(s): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.
Other intervention name(s): Aspart (Novolog)
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Point of care testing; Hypoglycemia; Basal bolus insulin