Hyperglycemia, Hematopoietic Stem Cell Transplantation
Conditions
Keywords
Hyperglycemia, Hematopoietic stem cell transplantation, Bone marrow transplant, High blood sugar
Brief summary
To determine whether intensive glucose control results in improved mortality and reduced hospital stay length by performing a randomized trial of intensive glucose management (blood glucose goal 110 mg/dl) using continuous IV insulin and glucose vs. non-intensive glucose management (goal 200 mg/dl)
Detailed description
TO determine whether there are fewer infections, days without a fever, days on antibiotics given for an infection and time to marrow engraftment are improved by intensive glucose management; and to determine whether there is evidence of a reduction in measures of inflammation in patients randomized to intensive glucose management and whether reduction of inflammation is associated with outcome.
Interventions
DRUGRegular Insulin
Use of sliding scale insulin as per Appendix 1
DEVICEDeployment of the MiniMed Paradigm monitoring device
Automated insulin delivery system
Sponsors
Oklahoma Center for the Advancement of Science and Technology
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 * Must meet standard criteria for HSCT * If patient is known diabetic at admit the may be maintained on home sulfonylurea and insulin if randomized to the conventional arm
Exclusion criteria
* If on intensive arm patient must stop all oral hyperglycemic meds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT) | 100 days |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of Infection | About 100 days |
| Reduced Length of In-hospital Stay | About 100 days |
Countries
United States
Participant flow
Recruitment details
Recruitment was not satisfactory to study completion; study terminated early.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| 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 | 6 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Arm 2 | Arm 1 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 2 | 60 years STANDARD_DEVIATION 1 | 59 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 6 participants | 5 participants | 11 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
Primary
Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)
Time frame: 100 days
Population: Due to early termination, data not analyzed
Secondary
Reduced Length of In-hospital Stay
Time frame: About 100 days
Secondary
Reduction of Infection
Time frame: About 100 days