Point-of-Care Glucose Testing and Insulin Supplementation

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Drug: Bedtime insulin Aspart (Novolog)

• Registration Number: NCT01702311
• Lead Sponsor: Emory University

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-08
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-07-02
• Results First Submitted QC: 2014-07-02
• Results First Posted: 2014-08-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-05
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bedtime supplementation	Bedtime insulin Aspart (Novolog)	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.

Primary Outcome Measures

Name	Time	Method
Mean Fasting Blood Glucose	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.

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	participants will be followed for the duration of hospital stay, an expected average of 6 days	Length of hospitalization
Hospital Mortality	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
Pneumonia	participants will be followed for the duration of hospital stay, an expected average of 6 days	Pneumonia (CDC criteria)
Bacteremia	participants will be followed for the duration of hospital stay, an expected average of 6 days	Bacteremia with SIRS/Sepsis
Mean Daily BG	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)	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.
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	Acute renal failure \[rise \>50% of baseline or creatinine \>2.5 mg/dl\]
Daily Dose of Insulin	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
Nosocomial Infections (CDC)	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
Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days	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
Number of BG Within Target	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	Subjects will be followed over the hospital stay: expected 6 days

Trial Locations

Locations (2)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States