Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Glucose Control In Hematopoetic Stem Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00582036
Recruitment Status : Terminated (study terminated due to lack of enrollment)
First Posted : December 28, 2007
Results First Posted : April 22, 2011
Last Update Posted : April 22, 2011
Sponsor:
Collaborator:
Oklahoma Center for the Advancement of Science and Technology
Information provided by:
University of Oklahoma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hyperglycemia
Hematopoietic Stem Cell Transplantation
Interventions Drug: Regular Insulin
Device: Deployment of the MiniMed Paradigm monitoring device
Enrollment 11
Recruitment Details Recruitment was not satisfactory to study completion; study terminated early.
Pre-assignment Details  
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin

Baseline IV Insulin infusion begins with:

>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime

Sliding Scale IV Insulin adjustments based on:

>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion

Period Title: Overall Study
Started 5 6
Completed 5 5 [1]
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
[1]
One patient withdrew consent
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin

Baseline IV Insulin infusion begins with:

>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime

Sliding Scale IV Insulin adjustments based on:

>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion

Total of all reporting groups
Overall Number of Baseline Participants 5 6 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
6
 100.0%
11
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 6 participants 11 participants
60  (1) 58  (2) 59  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
Female
3
  60.0%
1
  16.7%
4
  36.4%
Male
2
  40.0%
5
  83.3%
7
  63.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 6 participants 11 participants
5 6 11
1.Primary Outcome
Title Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)
Hide Description [Not Specified]
Time Frame 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination, data not analyzed
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin

Baseline IV Insulin infusion begins with:

>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime

Sliding Scale IV Insulin adjustments based on:

>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Reduction of Infection
Hide Description [Not Specified]
Time Frame About 100 days
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Reduced Length of In-hospital Stay
Hide Description [Not Specified]
Time Frame About 100 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin

Baseline IV Insulin infusion begins with:

>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime

Sliding Scale IV Insulin adjustments based on:

>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion

All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
This study was terminated early due to lack of enrollment.
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: George Selby, MD
Organization: University of Oklahoma Health Sciences Center
Phone: 405-271-4022
EMail: george-selby@ouhsc.edu
Layout table for additonal information
Responsible Party: Goerge Selby, MD, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00582036    
Other Study ID Numbers: Glucose Control
OCAST HR06-13
First Submitted: December 19, 2007
First Posted: December 28, 2007
Results First Submitted: January 6, 2011
Results First Posted: April 22, 2011
Last Update Posted: April 22, 2011