Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy
Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy
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.
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