Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy (GluCon-Chemo)

Slotervaart Hospital

Status and phase: Completed; Phase 4

Conditions: Hyperglycemia Steroid-induced

Treatments: Drug: Glucose lowering medication; Drug: Chemotherapy; Drug: Intermediate acting insulin; Behavioral: Dietary advice; Drug: Sliding scale insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT02155374

NL47135.048.13

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Sliding scale insulin

Active Comparator group

Description:

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

Treatment:

Drug: Glucose lowering medication

Drug: Sliding scale insulin

Behavioral: Dietary advice

Drug: Chemotherapy

Intermediate acting insulin

Experimental group

Description:

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)

Treatment:

Drug: Glucose lowering medication

Behavioral: Dietary advice

Drug: Intermediate acting insulin

Drug: Chemotherapy