HyperglycemiaNCT00582036
Glucose Control In Hematopoetic Stem Cell Transplant
A study testing Regular Insulin and Deployment of the MiniMed Paradigm monitoring device in people with Hyperglycemia and Hematopoietic Stem Cell Transplantation, run by University of Oklahoma at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Regular Insulin and Deployment of the MiniMed Paradigm monitoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to May 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- If on intensive arm patient must stop all oral hyperglycemic meds
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
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)
Read the 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.
- Being tested
- Regular Insulin, Deployment of the MiniMed Paradigm monitoring device
- Keywords
- Hyperglycemia, Hematopoietic stem cell transplantation, Bone marrow transplant, High blood sugar
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular InsulinDrug
Use of sliding scale insulin as per Appendix 1
Deployment of the MiniMed Paradigm monitoring deviceDevice
Automated insulin delivery system
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Regular Sliding Scale Insulin administration for hyperglycemia Receives: Drug: Regular Insulin |
| Arm 2 | Experimental | MiniMed Paradigm monitoring device for hyperglycemia Receives: Device: Deployment of the MiniMed Paradigm monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)
Measured: 100 days
Secondary outcomes (2)
Reduction of Infection
Measured: About 100 days
Reduced Length of In-hospital Stay
Measured: About 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: study terminated due to lack of enrollment
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.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma Center for the Advancement of Science and Technology
- Responsible party
- Sponsor
- Investigators
- George Selby, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582036
- Sponsor's protocol ID
- 13219T
- Other IDs
- OCAST HR06-13
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2007
- Last updated
- 20 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Control In Hematopoetic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT00582036
- Acronym / sponsor ID
- 13219T
- Keywords
- Hyperglycemia, Hematopoietic stem cell transplantation, Bone marrow transplant, High blood sugar
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study terminated due to lack of enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma Center for the Advancement of Science and Technology
- Study start
- Feb 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Posted 22 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Regular InsulinRegular Sliding Scale Insulin administration for hyperglycemia |
| Arm 2 | Experimental | Device: Deployment of the MiniMed Paradigm monitoring deviceMiniMed Paradigm monitoring device for hyperglycemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- If on intensive arm patient must stop all oral hyperglycemic meds
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 |
|---|---|---|
| Regular InsulinUse of sliding scale insulin as per Appendix 1 | Drug | Arm 1 |
| Deployment of the MiniMed Paradigm monitoring deviceAutomated insulin delivery system | Device | Arm 2 |
Primary outcome
Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)
Time frame: 100 days
2 secondary outcomes
Reduction of Infection
Time frame: About 100 days
Reduced Length of In-hospital Stay
Time frame: About 100 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
George Selby, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Insulin and Deployment of the MiniMed Paradigm monitoring device in people with Hyperglycemia and Hematopoietic Stem Cell Transplantation, run by University of Oklahoma at 1 site 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 22 Apr 2011). 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?
Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT) (time frame: 100 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026.