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Point-of-Care Glucose Testing and Insulin Supplementation (POC)

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ClinicalTrials.gov Identifier: NCT01702311
Recruitment Status : Completed
First Posted : October 8, 2012
Results First Posted : August 1, 2014
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes
Intervention Drug: Bedtime insulin Aspart (Novolog)
Enrollment 235
Recruitment Details General medicine and surgery patients admitted to Emory University and Grady Hospital between May 2012 and December 2013
Pre-assignment Details  
Arm/Group Title Bedtime Supplementation No Bedtime Supplementation
Hide Arm/Group Description

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.

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

Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Period Title: Overall Study
Started 122 113
Completed 106 100
Not Completed 16 13
Reason Not Completed
Withdrawal by Subject             3             2
Discharge less than 24 hours             10             7
Physician Decision             3             4
Arm/Group Title Bedtime Supplementation No Bedtime Supplementation Total
Hide Arm/Group Description

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.

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

Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation. Total of all reporting groups
Overall Number of Baseline Participants 106 100 206
Hide Baseline Analysis Population Description
16 subjects were not included in the data analysis for bedtime supplementation arm 13 subjects were not included in the data analysis for no bedtime supplementation arm
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 100 participants 206 participants
58  (10) 57  (11) 57  (11)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 100 participants 206 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
84
  79.2%
75
  75.0%
159
  77.2%
>=65 years
22
  20.8%
25
  25.0%
47
  22.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 100 participants 206 participants
Female
46
  43.4%
46
  46.0%
92
  44.7%
Male
60
  56.6%
54
  54.0%
114
  55.3%
1.Primary Outcome
Title Mean Fasting Blood Glucose
Hide Description 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.
Time Frame up to 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bedtime Supplementation No Bedtime Supplementation
Hide Arm/Group Description:

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.

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

Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Overall Number of Participants Analyzed 106 100
Mean (Standard Deviation)
Unit of Measure: mg/dL
162  (44) 157  (41)
2.Secondary Outcome
Title Mean Daily BG
Hide Description Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG
Time Frame participants will be followed for the duration of hospital stay, an expected average of 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title no Bedtime Supplementation Bedtime Supplementation
Hide Arm/Group Description:
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.

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.

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

Overall Number of Participants Analyzed 100 106
Mean (Standard Deviation)
Unit of Measure: mmol/L
8.8  (1.7) 8.7  (1.8)
3.Secondary Outcome
Title Number of Hypoglycemia (BG < 70 mg/dl)
Hide Description Secondary outcomes include the number of hypoglycemia (BG < 70 mg/dl) among both the groups.
Time Frame participants will be followed for the duration of hospital stay, an expected average of 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bedtime Supplementation no Bedtime Supplementation
Hide Arm/Group Description:

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.

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

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.
Overall Number of Participants Analyzed 106 100
Measure Type: Number
Unit of Measure: number of events
32 26
4.Secondary Outcome
Title Daily Dose of Insulin
Hide Description Compare the daily dose of insulin used among both groups
Time Frame participants will be followed for the duration of hospital stay, an expected average of 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bedtime Supplementation No Bedtime Supplementation
Hide Arm/Group Description:

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.

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

Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Overall Number of Participants Analyzed 106 100
Mean (Standard Deviation)
Unit of Measure: units/day
39  (23) 44  (33)
5.Secondary Outcome
Title Length of Hospital Stay
Hide Description Length of hospitalization
Time Frame participants will be followed for the duration of hospital stay, an expected average of 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bedtime Supplementation No Bedtime Supplementation
Hide Arm/Group Description:

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.

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

Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Overall Number of Participants Analyzed 106 100
Median (Inter-Quartile Range)
Unit of Measure: days
7
(4 to 13)
6
(5 to 9)
6.Secondary Outcome
Title Hospital Mortality
Hide Description Mortality is defined as death occurring during admission or during the hospital stay
Time Frame participants will be followed for the duration of hospital stay, an expected average of 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bedtime Supplementation No Bedtime Supplementation
Hide Arm/Group Description:

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.

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

Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Overall Number of Participants Analyzed 106 100
Measure Type: Number
Unit of Measure: number of events
0 1
7.Secondary Outcome
Title Nosocomial Infections (CDC)
Hide Description Nosocomial infections during hospital stay as per the CDC criteria
Time Frame participants will be followed for the duration of hospital stay, an expected average of 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bedtime Supplementation No Bedtime Supplementation
Hide Arm/Group Description:

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.

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

Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Overall Number of Participants Analyzed 106 100
Measure Type: Number
Unit of Measure: number of events
0 0
8.Secondary Outcome
Title Pneumonia
Hide Description Pneumonia (CDC criteria)
Time Frame participants will be followed for the duration of hospital stay, an expected average of 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bedtime Supplementation No Bedtime Supplementation
Hide Arm/Group Description:

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.

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

Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Overall Number of Participants Analyzed 106 100
Measure Type: Number
Unit of Measure: number of events
1 0
9.Secondary Outcome
Title Bacteremia
Hide Description Bacteremia with SIRS/Sepsis
Time Frame participants will be followed for the duration of hospital stay, an expected average of 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bedtime Supplementation No Bedtime Supplementation
Hide Arm/Group Description:

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.

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

Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Overall Number of Participants Analyzed 106 100
Measure Type: Number
Unit of Measure: number of events
0 0
10.Secondary Outcome
Title Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days
Hide Description Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg
Time Frame daily while in hospital for up to 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bedtime Supplementation No Bedtime Supplementation
Hide Arm/Group Description:

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.

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

Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Overall Number of Participants Analyzed 106 100
Measure Type: Number
Unit of Measure: number of events
1 0
11.Secondary Outcome
Title Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bedtime Supplementation No Bedtime Supplementation
Hide Arm/Group Description:

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.

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

Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Overall Number of Participants Analyzed 106 100
Measure Type: Number
Unit of Measure: number of events
4 4
12.Secondary Outcome
Title Number of BG Within Target
Hide Description Number of glucose levels within target of 70-140 mg/dl
Time Frame Participants will be followed over the hospital stay- expected 6 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bedtime Supplementation No Bedtime Supplementation
Hide Arm/Group Description:

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.

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

Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Overall Number of Participants Analyzed 106 100
Measure Type: Number
Unit of Measure: participants
76 74
13.Secondary Outcome
Title Number of Subjects With BG > 300 mg/dL
Hide Description [Not Specified]
Time Frame Subjects will be followed over the hospital stay: expected 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title no Bedtime Supplementation Bedtime Supplementation
Hide Arm/Group Description:
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.

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.

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

Overall Number of Participants Analyzed 100 106
Measure Type: Number
Unit of Measure: participants
19 13
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bedtime Supplementation No Bedtime Supplementation
Hide Arm/Group Description

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.

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

Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
All-Cause Mortality
Bedtime Supplementation No Bedtime Supplementation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bedtime Supplementation No Bedtime Supplementation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bedtime Supplementation No Bedtime Supplementation
Affected / at Risk (%) Affected / at Risk (%)
Total   32/106 (30.19%)   26/100 (26.00%) 
Endocrine disorders     
Hypoglycemic events  [1]  32/106 (30.19%)  26/100 (26.00%) 
Indicates events were collected by systematic assessment
[1]
blood glucose less than 70 mg/dL
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Guillermo Umpierrez, MD
Organization: Emory University
Phone: 404-778-1663
EMail: geumpie@emory.edu
Layout table for additonal information
Responsible Party: Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier: NCT01702311     History of Changes
Other Study ID Numbers: IRB00056041
First Submitted: May 8, 2012
First Posted: October 8, 2012
Results First Submitted: July 2, 2014
Results First Posted: August 1, 2014
Last Update Posted: January 3, 2018