Point-of-Care Glucose Testing and Insulin Supplementation (POC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT01702311
First received: May 8, 2012
Last updated: June 7, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Diabetes
Drug: hs insulin Aspart (Novolog)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Benefits of Point-of-Care Glucose Testing and Insulin Supplementation at Bedtime in Insulin Treated Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • mean fasting blood glucose [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
    The primary outcome of the study is to compare differences in mean fasting BG levels between patients receiving insulin supplements at bedtime compared to those without insulin supplementation.


Secondary Outcome Measures:
  • mean daily BG and number of BG within target [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
    Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG and number of BG within target

  • Number of hypoglycemia (BG < 70 mg/dl) and severe hyperglycemia (BG>300 mg/dl) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: Yes ]
    Secondary outcomes include the number of hypoglycemia (BG < 70 mg/dl) and severe hyperglycemia (BG>300 mg/dl) among both the groups.

  • Daily dose of insulin [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
    Compare the daily dose of insulin used among both groups

  • Length of hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: Yes ]
    Length of hospitalization

  • Hospital Mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: Yes ]
    Mortality is defined as death occurring during admission or during the hospital stay

  • Nosocomial infections (CDC) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: Yes ]
    Nosocomial infections during hospital stay as per the CDC criteria

  • Pneumonia [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: Yes ]
    Pneumonia (CDC criteria)

  • Bacteremia [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: Yes ]
    Bacteremia with SIRS/Sepsis

  • participants will be followed for the duration of hospital stay, an expected average of 6 days [ Time Frame: daily while in hospital for up to 10 days ] [ Designated as safety issue: Yes ]
    Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg

  • 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 ] [ Designated as safety issue: Yes ]
    Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl]


Enrollment: 200
Study Start Date: May 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: qhs supplementation
Patients in this arm will have acqhs and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.
Drug: hs insulin Aspart (Novolog)
hs insulin aspart supplementation based on BG value in the qhs supplementation arm.
Other Name: Aspart (Novolog)
No Intervention: no qhs supplementation
Patients in this arm will have ac, qhs and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin hs supplementation.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702311

Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Guillermo E Umpierrez, MD Emory University
  More Information

No publications provided

Responsible Party: Guillermo Umpierrez, Prinicipal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01702311     History of Changes
Other Study ID Numbers: IRB00056041
Study First Received: May 8, 2012
Last Updated: June 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Diabetes
Point of care testing
Hypoglycemia
Basal bolus insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014