Point-of-Care Glucose Testing and Insulin Supplementation

NCT ID: NCT01702311

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-12-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Bedtime insulin Aspart (Novolog)

Intervention Type: DRUG

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bedtime insulin Aspart (Novolog)

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

Intervention Type: DRUG

Other Intervention Names

Aspart (Novolog)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo E Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25665812 (View on PubMed)

Other Identifiers

IRB00056041

Identifier Type: -

Identifier Source: org_study_id