Hyperglycemia Steroid-induced
Conditions
Keywords
Glucocorticoid induced hyperglycemia, insulin, chemotherapy
Brief summary
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.
Interventions
DRUGIntermediate acting insulin
BEHAVIORALDietary advice
Dietary advice to avoid food products with high glycemic index / high glucose load
DRUGGlucose lowering medication
Regular glucose lowering medication as prescribed by the patient's own physician before study entry
DRUGChemotherapy
Chemotherapy (containing glucocorticoids) as prescribed by the patient's own physician
Sponsors
Slotervaart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | 24h till end of treatment (expected duration 4-8 days) | Compare achievement of glycemic control in SSI therapy and intermediate acting insulin. Glycemic control is measured as the proportion of blood glucose measurements (BGM) within target range in each subject after 24h of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | At the end of each treatment cycle (expected duration 4-8 days) | Compare patient satisfaction in each treatment regimen at a 6-point Likert scale, in the last cycle we evaluate patient's preference for glucose lowering treatment in next chemotherapy cycle (SSI or intermediate acting insulin) |
| Clinical outcomes | During each treatment (expected duration 4-8 days) | Difference in clinical outcomes: incidence of oral candidiasis, pooled incidence of grade 3-4 chemotoxicity. Data on clinical outcomes will be collected by taking the patient history at the end of each treatment cycle. |
| Hypoglycemia | During each treatment (expected duration 4-8 days) | Incidence of hypoglycemia in each treatment cycle defined as an interstitial glucose ≤ 3.9 mmol/l continuing until the interstitial glucose is \>3.9 mmol/l |
Countries
Netherlands
Outcome results
None listed