Glucocorticoid induced hyperglycemia High blood glucose caused by anti-inflammatory medication
Conditions
Interventions
Subjects will be consecutively treated by (A) NPH insulin once daily and by (B)
short acting insulin in a sliding scale regimen. The order of the treatment
regimens will be determined by randomizati
Sponsors
Slotervaartziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Glucocorticoid induced hyperglycemia in previous cycle of chemotherapy that required therapy initiation or adjustment - Duration of glucocorticoid cycles 4-10 consecutive days and * 4 glucocorticoid-free days between 2 cycles - Age * 18 years & written informed consent - Prednisone-equivalent dose of * 12,5mg - At least 2 more cycles of chemotherapy to receive
Exclusion criteria
Exclusion criteria: history of hypo-unawareness, continuous tube or parental feeding, continuous (maintenance) systemic glucocorticoid therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For each subject, we calculate the fraction of glucose measurements within target range during a chemotherapy cycle (a continuous variable). The mean difference of this fraction between treatment cycles is the outcome variable. | — |
Secondary
| Measure | Time frame |
|---|---|
| Regarding glycemic control: o Difference in average daily blood glucose after 24h of treatment o Difference of proportion of subjects within target range in each treatment condition o Difference in average number of blood glucose measurements per treatment day o Difference in average insulin daily dose per treatment day o Difference in proportion of measurements above and lower than target range o Incidence of severe hypoglycemia Treatment satisfaction: patient preference for treatment regimen in third chemotherapy cycle Clinical outcomes: incidence of common (hyperglycemia related) chemotoxicity o Incidence of oral candidiasis o Pooled incidence of all G3-4 chemotoxicity | — |
Countries
Netherlands
Outcome results
None listed