A Phase 4 interventional study of Sliding scale insulin and Intermediate acting insulin in Hyperglycemia Steroid-induced, sponsored by Slotervaart Hospital. Completed at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-07.
Sponsored by Slotervaart Hospital · Phase 4, Interventional, and Supportive care
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.
699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.
This study's enrollment of 26 is below the median of 46 across 521 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →Slotervaart Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sliding 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
Drug: Sliding scale insulin · Behavioral: Dietary advice · Drug: Glucose lowering medication · Drug: Chemotherapy
Intermediate 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)
Drug: Intermediate acting insulin · Behavioral: Dietary advice · Drug: Glucose lowering medication · Drug: Chemotherapy
Also known as: Short acting insulin on a sliding scale base
Also known as: NPH insulin, insulatard
Dietary advice to avoid food products with high glycemic index / high glucose load
Regular glucose lowering medication as prescribed by the patient's own physician before study entry
Chemotherapy (containing glucocorticoids) as prescribed by the patient's own physician
Also known as: Antineoplastic therapy
Glycemic control
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
Time frame: 24h till end of treatment (expected duration 4-8 days)
Patient satisfaction
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)
Time frame: At the end of each treatment cycle (expected duration 4-8 days)
Clinical outcomes
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.
Time frame: During each treatment (expected duration 4-8 days)
Hypoglycemia
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
Time frame: During each treatment (expected duration 4-8 days)
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Slotervaart Hospital