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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
235

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Bedtime insulin Aspart (Novolog)
Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.
Other Names:
  • Aspart (Novolog)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
up to 10 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
Pneumonia
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
Pneumonia (CDC criteria)
participants will be followed for the duration of hospital stay, an expected average of 6 days
Bacteremia
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
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
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
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
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
Number of BG Within Target
Time Frame: Participants will be followed over the hospital stay- expected 6 days.
Number of glucose levels within target of 70-140 mg/dl
Participants will be followed over the hospital stay- expected 6 days.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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