HyperglycemiaEarly Phase 1NCT03904199
Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia
A Early Phase 1 study testing Insulin in people with Hyperglycemia, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to compare the outcomes between hospitalized cancer patients with high blood sugar receiving the current standard of care of administering insulin, and hospitalized cancer patients receiving a new, individualized method of insulin administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 2 Nov 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Provide race and ethnicity information
- Male or female, aged 18 years or greater
- Diagnosed with cancer
- Hospitalized at MCC in the medical, hematologic, or bone marrow transplant units
- Having in-hospital hyperglycemia with or without a pre-existing diagnosis of DM, with 2 measurements of BG > 180 mg/dL and/or 1 measurement of BG > 350mg/dL within the first 72 hours of admission, detected by bedside point-of-care testing and/or basic metabolic panel laboratory data.
- Participants enrolled in other clinical trials are admissible to this trial.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Participants < 18 years of age
- Participants at the end of life and/or with limited life expectancies (< 6 months)
- Participants without cancer diagnoses
- Surgical patients and patients admitted directly to the intensive care unit, other than those in the Bone Marrow Transplant Unit, who are included
- Participants treated and discharged in outpatient settings (ie, direct referral center, infusion center, or clinical research unit) or those admitted for observation only (hospitalized less than 24 hours)
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- Participants on total parenteral nutrition
- Participants on insulin pumps
- Participants admitted with diabetic ketoacidosis and hyperglycemic hyperosmolar syndrome
- Pregnant Participants based on medical history
- Participants being followed by endocrinology for hyperglycemia or hypoglycemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Study of a Personalized Approach to the Inpatient Management of Hospitalized Oncology Patients With Hyperglycemia
The purpose of this study is to compare the outcomes between hospitalized cancer patients with high blood sugar receiving the current standard of care of administering insulin, and hospitalized cancer patients receiving a new, individualized method of insulin administration.
- Conditions
- Hyperglycemia
- Being tested
- Insulin
- Keywords
- High Blood Sugar, High Blood Glucose
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Also called Basal insulin, Prandial insulin
Participants will receive long-acting insulin and/or rapid-acting insulin per protocol
| Study group | Role | What they receive |
|---|---|---|
| Basal-Prandial-Correctional Insulin Regimen | Experimental | Participants hospitalized in the medical, hematologic, or bone marrow transplant units will begin with basal long-acting insulin glargine with correctional and prandial rapid-acting insulin that is personalized and precise, to achieve target blood glucose levels with daily assessments during hospitalization. Adjustments will be made in real time to reach the target range. Receives: Drug: Insulin |
| Standard of Care Insulin Regimen | Active comparator | Participants hospitalized in the medical, hematologic, or bone marrow transplant units' blood sugar levels will be managed with sliding scale insulin or a combination of long- and short-acting insulin as per standard of care. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of blood glucose values within normal range
Proportion of blood glucose values in the 70 mg/dL to 180 mg/dL (normal) range
Measured: During hospital admission, up to 30 days
Secondary outcomes (3)
Proportion of high blood glucose levels
Proportion of blood glucose values >180 mg/dL
Measured: During hospital admission, up to 30 days
Proportion of low blood glucose levels
Proportion of blood glucose values <70 mg/dL
Measured: During hospital admission, up to 30 days
Duration of normal blood glucose level
Duration of blood glucose values in the 70 mg/dL to 180 mg/dL (normal) range
Measured: During hospital admission, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start4 Apr 2019
- Primary completion14 Oct 2020
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Smitha Pabbathi, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904199
- Sponsor's protocol ID
- MCC-19637
- Status last verified
- Jan 2023
- First submitted
- 3 Apr 2019
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of a Personalized Approach to the Inpatient Management of Hospitalized Oncology Patients With Hyperglycemia
- ClinicalTrials.gov ID
- NCT03904199
- Acronym / sponsor ID
- MCC-19637
- Conditions
- Hyperglycemia
- Keywords
- High Blood Sugar, High Blood Glucose
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the outcomes between hospitalized cancer patients with high blood sugar receiving the current standard of care of administering insulin, and hospitalized cancer patients receiving a new, individualized method of insulin administration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basal-Prandial-Correctional Insulin Regimen | Experimental | Drug: InsulinParticipants hospitalized in the medical, hematologic, or bone marrow transplant units will begin with basal long-acting insulin glargine with correctional and prandial rapid-acting insulin that is personalized and precise, to achieve target blood glucose levels with daily assessments during hospitalization. Adjustments will be made in real time to reach the target range. |
| Standard of Care Insulin Regimen | Active comparator | Drug: InsulinParticipants hospitalized in the medical, hematologic, or bone marrow transplant units' blood sugar levels will be managed with sliding scale insulin or a combination of long- and short-acting insulin as per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Provide race and ethnicity information
- Male or female, aged 18 years or greater
- Diagnosed with cancer
Key exclusion criteria (11 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Participants < 18 years of age
- Participants at the end of life and/or with limited life expectancies (< 6 months)
- Participants without cancer diagnoses
- Surgical patients and patients admitted directly to the intensive care unit, other than those in the Bone Marrow Transplant Unit, who are included
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 |
|---|---|---|
| InsulinAlso: Basal insulin, Prandial insulinParticipants will receive long-acting insulin and/or rapid-acting insulin per protocol | Drug | Basal-Prandial-Correctional Insulin Regimen, Standard of Care Insulin Regimen |
Primary outcome
Proportion of blood glucose values within normal range
Time frame: During hospital admission, up to 30 days
Proportion of blood glucose values in the 70 mg/dL to 180 mg/dL (normal) range
3 secondary outcomes
Proportion of high blood glucose levels
Time frame: During hospital admission, up to 30 days
Proportion of low blood glucose levels
Time frame: During hospital admission, up to 30 days
Duration of normal blood glucose level
Time frame: During hospital admission, up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Smitha Pabbathi, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Insulin in people with Hyperglycemia, run by H. Lee Moffitt Cancer Center and Research Institute 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 20 Jan 2023. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of blood glucose values within normal range (time frame: During hospital admission, up to 30 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 Jan 2023.