Point-of-Care Glucose Testing and Insulin Supplementation

Diabetes Clinical Trial

— POC  

Official title:

Benefits of Point-of-Care Glucose Testing and Insulin Supplementation at Bedtime in Insulin Treated Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702311
• Other study ID #: IRB00056041
• Status: Completed
• Phase: N/A
• First received: May 8, 2012
• Last updated: December 5, 2017
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Bedtime insulin Aspart (Novolog)
Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Length of Hospital Stay	Length of hospitalization	participants will be followed for the duration of hospital stay, an expected average of 6 days
Secondary	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
Secondary	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
Secondary	Pneumonia	Pneumonia (CDC criteria)	participants will be followed for the duration of hospital stay, an expected average of 6 days
Secondary	Bacteremia	Bacteremia with SIRS/Sepsis	participants will be followed for the duration of hospital stay, an expected average of 6 days
Secondary	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
Secondary	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
Secondary	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.
Secondary	Number of Subjects With BG > 300 mg/dL		Subjects will be followed over the hospital stay: expected 6 days