Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Pati… (NCT02012465) | Clinical Trial Compass
CompletedEarly Phase 1
Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Patients
United States15 participantsStarted 2013-09
Plain-language summary
There are no guidelines for the management of glucocorticoid- (henceforth steroid) induced elevated blood sugars (henceforth hyperglycemia). Oncology ward patients have particularly high rates of hyperglycemia and are frequently exposed to high dose steroid therapy. A prior study by Muthala et al. (unpublished data) found a relationship between insulin requirements needed to maintain normal blood sugars, patient weight, and mg of steroid administered. In this pilot study, through an endocrine consult team, a weight-based, steroid dose-based insulin protocol will be implemented for the management of hyperglycemia in lymphoma patients requiring high dose steroid therapy, with the goal of reducing hyperglycemia incidence.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
For diabetics enrolled on admission:
Inclusion Criteria:
* Age ≥ 18 years old
* Type 2 diabetes mellitus treated with insulin secretagogues or insulin prior to hospitalization
* Diagnosis of lymphoma
* Plan to treat with steroids of minimum equivalent of 20 mg prednisone per day
* Hospitalized for at least 48 hours
* Decision-making capacity to provide own consent
Exclusion Criteria:
* Type 1 diabetes
* Any contraindication to insulin therapy
* Patients only on single agent therapy such as metformin, thiazolidinediones (TZDs), Dipeptidyl peptidase-4 (DPP4) inhibitors, or Exenatide®, for safety concerns
* Insulin requirement of \>1.5 units of insulin/kg
* If a patient required ICU stay during the hospitalization, data from 12 hours before, during, and 12 hours after ICU stay will be omitted to avoid confounding of the effect of critical illness on glycemic control
* Pregnancy, confirmed with a urine b-human chorionic gonadotropin (HCG) (for all women between the age of 18 and 60 years old)
Patients who develop a blood glucose \> 235 mg/dL after admission will be eligible for study enrollment based on the following:
Inclusion criteria:
* Age ≥ 18 years old
* Diagnosis of lymphoma
* Plan to treat with steroids of minimum equivalent of 20 mg prednisone per day
* Will be hospitalized for at least an additional 48 hours
* Decision-making capacity to provide own consent
Exclusion criteria:
* Any contraindication to insulin therapy
* If a patient required ICU stay during the…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.