- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01702311
Point-of-Care Glucose Testing and Insulin Supplementation (POC)
December 5, 2017 updated by: Guillermo Umpierrez, Emory University
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Atlanta, Georgia, United States, 30303
- Grady Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
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Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.
Other Names:
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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
Time Frame: 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.
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up to 10 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Daily BG
Time Frame: 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
|
participants will be followed for the duration of hospital stay, an expected average of 6 days
|
Number of Hypoglycemia (BG < 70 mg/dl)
Time Frame: 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.
|
participants will be followed for the duration of hospital stay, an expected average of 6 days
|
Daily Dose of Insulin
Time Frame: 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
|
participants will be followed for the duration of hospital stay, an expected average of 6 days
|
Length of Hospital Stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
|
Length of hospitalization
|
participants will be followed for the duration of hospital stay, an expected average of 6 days
|
Hospital Mortality
Time Frame: 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
|
participants will be followed for the duration of hospital stay, an expected average of 6 days
|
Nosocomial Infections (CDC)
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
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Nosocomial infections during hospital stay as per the CDC criteria
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participants will be followed for the duration of hospital stay, an expected average of 6 days
|
Pneumonia
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
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Pneumonia (CDC criteria)
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participants will be followed for the duration of hospital stay, an expected average of 6 days
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Bacteremia
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
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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
Time Frame: daily while in hospital for up to 10 days
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Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg
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daily while in hospital for up to 10 days
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Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl]
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
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Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl]
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participants will be followed for the duration of hospital stay, an expected average of 6 days
|
Number of BG Within Target
Time Frame: Participants will be followed over the hospital stay- expected 6 days.
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Number of glucose levels within target of 70-140 mg/dl
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Participants will be followed over the hospital stay- expected 6 days.
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Number of Subjects With BG > 300 mg/dL
Time Frame: Subjects will be followed over the hospital stay: expected 6 days
|
Subjects will be followed over the hospital stay: expected 6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guillermo E Umpierrez, MD, Emory University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00056041
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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