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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: Bedtime insulin Aspart (Novolog)

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: Interventional
• Enrollment (Actual): 235
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Bedtime insulin Aspart (Novolog); Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.; Other Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Daily BG	Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG	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.	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	participants will be followed for the duration of hospital stay, an expected average of 6 days
Length of Hospital Stay	Length of hospitalization	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	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	participants will be followed for the duration of hospital stay, an expected average of 6 days
Pneumonia	Pneumonia (CDC criteria)	participants will be followed for the duration of hospital stay, an expected average of 6 days
Bacteremia	Bacteremia with SIRS/Sepsis	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	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]	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	Participants will be followed over the hospital stay- expected 6 days.
Number of Subjects With BG > 300 mg/dL		Subjects will be followed over the hospital stay: expected 6 days

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Guillermo E Umpierrez, MD, Emory University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 8, 2012
• First Submitted That Met QC Criteria: October 4, 2012
• First Posted (Estimate): October 8, 2012

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes; Hypoglycemia; Point of care testing; Basal bolus insulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Aspart
• Other Study ID Numbers: IRB00056041