Trial Outcomes & Findings for Glucose Control In Hematopoetic Stem Cell Transplant (NCT NCT00582036)
NCT ID: NCT00582036
Last Updated: 2024-07-03
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
100 days
Results posted on
2024-07-03
Participant Flow
Recruitment was not satisfactory to study completion; study terminated early.
Participant milestones
| Measure |
Arm 1
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
|
Arm 2
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 Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm 1
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
|
Arm 2
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 Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Glucose Control In Hematopoetic Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Arm 1
n=5 Participants
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
|
Arm 2
n=6 Participants
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
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 1 • n=5 Participants
|
58 years
STANDARD_DEVIATION 2 • n=7 Participants
|
59 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 daysPopulation: Due to early termination, data not analyzed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: About 100 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: About 100 daysOutcome measures
Outcome data not reported
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
George Selby, MD
University of Oklahoma Health Sciences Center
Phone: 405-271-4022
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place