Point-of-Care Glucose Testing and Insulin Supplementation

NCT01702311 | Completed Results DMC

• 1 other identifier: IRB00056041
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes

Keywords

Diabetes; Point of care testing; Hypoglycemia; Basal bolus insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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)

  participants will be followed for the duration of hospital stay, an expected average of 6 days

• Daily Dose of Insulin

  participants will be followed for the duration of hospital stay, an expected average of 6 days

• Length of Hospital Stay

  participants will be followed for the duration of hospital stay, an expected average of 6 days

• Hospital Mortality

  participants will be followed for the duration of hospital stay, an expected average of 6 days

Study Arms (2)

Bedtime supplementation

ACTIVE COMPARATOR

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)

no bedtime supplementation

NO INTERVENTION

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.

Interventions

Bedtime insulin Aspart (Novolog) DRUG

Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.

Also known as: Aspart (Novolog)

Bedtime supplementation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients with a known history of T2DM for \> 3 months
• Age 18-80 years
• Home treatment with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy
• BG \> 140 mg and \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis

You may not qualify if:

• Hyperglycemia without a history of diabetes
• Acute critical illness admitted to the ICU or expected to require ICU admission
• Receiving continuous insulin infusion
• Clinically relevant hepatic disease
• Patients on corticosteroid therapy
• Patients with creatinine ≥ 3.5 mg/dl
• Subjects unable to sign consent
• Pregnancy

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• 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.

  PMID: 25665812 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Guillermo Umpierrez, MD
• Organization: Emory University

geumpie@emory.edu

404-778-1663

Study Officials

• Guillermo E Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: October 8, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 3, 2018
• Results First Posted: August 1, 2014

Record last verified: 2017-12

Locations

US (2)