Clinical Trial: Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Glucose Control for Glucocorticoid Induced Hyperglycemia During 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

Detailed Summary:
Sponsor: Slotervaart Hospital

Current Primary Outcome: Glycemic control [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patient satisfaction [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: Slotervaart Hospital

Dates:
Date Received: May 5, 2014
Date Started: May 2014
Date Completion:
Last Updated: January 6, 2016
Last Verified: January 2016