Hyperglycemia Steroid-induced | Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy
Hyperglycemia Steroid-induced research study
What is the primary objective of this study?
Objective: to determine which regimen results in best glycemic control and safety profile, expressed as glucose values within target range and occurrence of hypoglycemia. Secondary objective is to compare patient satisfaction, clinical outcomes and toxicity. Study design: Randomized open label cross-over study Study population: Patients ≥ 18 years, who developed glucocorticoid induced hyperglycemia requiring initiation or adjustment of antihyperglycemic agents in a previous chemotherapy cycle. Patient should have ≥2 cycles of chemotherapy scheduled, with 3-10 consecutive days of ≥12,5mg prednisone-equivalent glucocorticoid and a wash-out period of 4-38 days between each cycle. Intervention: subjects will be treated by insulin regimen A and B in random order during two consecutive cycles of chemotherapy. A) intermediate acting insulin 0.01 IU / mg prednisone-equivalent / kg body weight once daily subcutaneous B) Short-acting insulin according to sliding scale regimen, dose adjusted to current grade of hyperglycemia. Main study parameters: Difference in fraction of blood glucose measurements (BGM) within target range and occurrence of hypoglycemia. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both study treatments are just a slight variation in regular care for glucocorticoid induced hyperglycemia. Glycemic control is likely to improve due to treatments and increased counselling. All subjects will receive both treatment regimens. The burden consists of 16-32 extra BGMs over 2 x 4-10 days, wearing the glucose sensor, 1 venipuncture (if HbA1c and creatinin are not determined in routine laboratory within 3 months before start), and 1 randomization visit to the outpatient clinic. Potential risk is the occurrence of hypoglycemia, as is present in any insulin therapy. The investigators account for this risk by giving subjects dietary advice and education how to prevent, recognize and treat hypoglycemia.
Who is eligible to participate?
Inclusion Criteria: - Age ≥ 18 years - Written informed consent - Glucocorticoid induced hyperglycemia in previous cycle of chemotherapy that required therapy initiation or adjustment - Duration of glucocorticoid cycles 3-10 consecutive days and 4-38 glucocorticoid-free days between 2 cycles - Prednisone-equivalent dose of ≥ 12,5mg - At least 2 more cycles of chemotherapy to receive Exclusion Criteria: - History of hypo-unawareness - Continuous tube or parental feeding - Continuous (maintenance) systemic glucocorticoid therapy
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Sliding scale insulin
Drug:Intermediate acting insulin
Behavioral:Dietary adviceDietary advice to avoid food products with high glycemic index / high glucose load
Drug:Glucose lowering medicationRegular glucose lowering medication as prescribed by the patient's own physician before study entry
Drug:ChemotherapyChemotherapy (containing glucocorticoids) as prescribed by the patient's own physician
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Sliding scale insulinSliding scale insulin Glucose 7.8-12 mmol/l --> 2 IU insulin, glucose 12.1-17 mmol/l --> 4 IU insulin, glucose ≥17.1 mmol/l --> 6 IU insulin. In case of insufficient control, insulin doses will be increased
Intermediate acting insulinIntermediate acting insulin, 0.01 IU / mg prednison / kg body weight with a maximum of 0.5 unit insulin per kg body weight. In case of age > 70 years or diminished renal function (GFR <30ml/min)
Start Date: May 2014
Completed Date: January 2016
Phase: Phase 4
Primary Outcome: Glycemic control
Secondary Outcome: Patient satisfaction
Study sponsors, principal investigator, and references
Lead Sponsor: Slotervaart Hospital