Evaluation of two insulin regimens for control of glucocorticoid induced hyperglycemia during chemotherapy
Completed
- Conditions
- Glucocorticoid induced hyperglycemiaHigh blood glucose caused by anti-inflammatory medication1001842410027655
- Registration Number
- NL-OMON41445
- Lead Sponsor
- Slotervaartziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
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
history of hypo-unawareness, continuous tube or parental feeding, continuous (maintenance) systemic glucocorticoid therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>For each subject, we calculate the fraction of glucose measurements within<br /><br>target range during a chemotherapy cycle (a continuous variable). The mean<br /><br>difference of this fraction between treatment cycles is the outcome variable. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Regarding glycemic control:<br /><br>o Difference in average daily blood glucose after 24h of treatment<br /><br>o Difference of proportion of subjects within target range in each treatment<br /><br>condition<br /><br>o Difference in average number of blood glucose measurements per treatment day<br /><br>o Difference in average insulin daily dose per treatment day<br /><br>o Difference in proportion of measurements above and lower than target range<br /><br>o Incidence of severe hypoglycemia<br /><br><br /><br>Treatment satisfaction: patient preference for treatment regimen in third<br /><br>chemotherapy cycle<br /><br><br /><br>Clinical outcomes: incidence of common (hyperglycemia related) chemotoxicity<br /><br>o Incidence of oral candidiasis<br /><br>o Pooled incidence of all G3-4 chemotoxicity</p><br>