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

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ClinicalTrials.gov Identifier: NCT01702311
Recruitment Status : Completed
First Posted : October 8, 2012
Results First Posted : August 1, 2014
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

Tracking Information
First Submitted Date  ICMJE May 8, 2012
First Posted Date  ICMJE October 8, 2012
Results First Submitted Date  ICMJE July 2, 2014
Results First Posted Date  ICMJE August 1, 2014
Last Update Posted Date January 3, 2018
Study Start Date  ICMJE May 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
Mean Fasting Blood Glucose [ Time Frame: up to 10 days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2012)
Mean Fasting Blood Glucose [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ]
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.
Change History Complete list of historical versions of study NCT01702311 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
  • Mean Daily BG [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ]
    Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG
  • Number of Hypoglycemia (BG < 70 mg/dl) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ]
    Secondary outcomes include the number of hypoglycemia (BG < 70 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 ]
    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 ]
    Length of hospitalization
  • Hospital Mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ]
    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 ]
    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 ]
    Pneumonia (CDC criteria)
  • Bacteremia [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ]
    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 ]
    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 ]
    Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl]
  • Number of BG Within Target [ Time Frame: Participants will be followed over the hospital stay- expected 6 days. ]
    Number of glucose levels within target of 70-140 mg/dl
  • Number of Subjects With BG > 300 mg/dL [ Time Frame: Subjects will be followed over the hospital stay: expected 6 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2012)
  • 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 ]
    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 ]
    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 ]
    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 ]
    Length of hospitalization
  • Hospital Mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ]
    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 ]
    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 ]
    Pneumonia (CDC criteria)
  • Bacteremia [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ]
    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 ]
    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 ]
    Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Point-of-Care Glucose Testing and Insulin Supplementation
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes
Intervention  ICMJE Drug: Bedtime insulin Aspart (Novolog)
Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.
Other Name: Aspart (Novolog)
Study Arms  ICMJE
  • Active Comparator: Bedtime supplementation
    Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.
    Intervention: Drug: Bedtime insulin Aspart (Novolog)
  • No Intervention: no bedtime supplementation
    Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Publications * Vellanki P, Bean R, Oyedokun FA, Pasquel FJ, Smiley D, Farrokhi F, Newton C, Peng L, Umpierrez GE. Randomized controlled trial of insulin supplementation for correction of bedtime hyperglycemia in hospitalized patients with type 2 diabetes. Diabetes Care. 2015 Apr;38(4):568-74. doi: 10.2337/dc14-1796. Epub 2015 Feb 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2017)
235
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2012)
250
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01702311
Other Study ID Numbers  ICMJE IRB00056041
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guillermo Umpierrez, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guillermo E Umpierrez, MD Emory University
PRS Account Emory University
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP