DiabetesPOCNCT01702311
Point-of-Care Glucose Testing and Insulin Supplementation
A study testing Bedtime insulin Aspart (Novolog) in people with Diabetes, run by Emory University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Bedtime insulin Aspart (Novolog)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: 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.
Read the 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
- Being tested
- Bedtime insulin Aspart (Novolog)
- Keywords
- Diabetes, Point of care testing, Hypoglycemia, Basal bolus insulin
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedtime insulin Aspart (Novolog)Drug
Also called Aspart (Novolog)
Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.
| Study group | Role | What they receive |
|---|---|---|
| Bedtime supplementation | Active comparator | 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. Receives: Drug: Bedtime insulin Aspart (Novolog) |
| no bedtime supplementation | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 10 days
Secondary outcomes (12)
Mean Daily BG
Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 days
Number of Hypoglycemia (BG < 70 mg/dl)
Secondary outcomes include the number of hypoglycemia (BG < 70 mg/dl) among both the groups.
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 days
Daily Dose of Insulin
Compare the daily dose of insulin used among both groups
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 days
Length of Hospital Stay
Length of hospitalization
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 days
Hospital Mortality
Mortality is defined as death occurring during admission or during the hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 days
Nosocomial Infections (CDC)
Nosocomial infections during hospital stay as per the CDC criteria
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 days
Pneumonia
Pneumonia (CDC criteria)
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 days
Bacteremia
Bacteremia with SIRS/Sepsis
Measured: 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
Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg
Measured: daily while in hospital for up to 10 days
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]
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 days
Number of BG Within Target
Number of glucose levels within target of 70-140 mg/dl
Measured: Participants will be followed over the hospital stay- expected 6 days.
Number of Subjects With BG > 300 mg/dL
Measured: Subjects will be followed over the hospital stay: expected 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo E Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702311
- Sponsor's protocol ID
- IRB00056041
- Acronym
- POC
- Status last verified
- Dec 2017
- First submitted
- 8 May 2012
- Last updated
- 3 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25665812
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Point-of-Care Glucose Testing and Insulin Supplementation at Bedtime in Insulin Treated Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01702311
- Acronym / sponsor ID
- POC / IRB00056041
- Conditions
- Diabetes
- Keywords
- Diabetes, Point of care testing, Hypoglycemia, Basal bolus insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Oct 2012 (estimated)
- Results
- Posted 1 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bedtime supplementation | Active comparator | Drug: 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. |
| no bedtime supplementation | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedtime insulin Aspart (Novolog)Also: Aspart (Novolog)Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm. | Drug | Bedtime supplementation |
Primary outcome
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.
12 secondary outcomes
Mean Daily BG
Time frame: 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
Daily Dose of Insulin
Time frame: 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
Hospital Mortality
Time frame: 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
Pneumonia
Time frame: 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
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
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
Number of BG Within Target
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25665812Vellanki 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.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo E Umpierrez, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedtime insulin Aspart (Novolog) in people with Diabetes, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Fasting Blood Glucose (time frame: up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01702311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.