Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy

NCT02155374 — Phase 4, Completed, 26 participants, Slotervaart Hospital

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Registry	NCT02155374, acronym GluCon-Chemo
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, crossover, masking: none, supportive care
Enrollment	26 (Actual)
Sponsor	Slotervaart Hospital (Other)
Conditions	Hyperglycemia Steroid-induced
Interventions	Sliding scale insulin, Intermediate acting insulin, Dietary advice, Glucose lowering medication, Chemotherapy (Drug, behavioral)
Dates	start 2014-05-01, primary completion 2015-12-01, completion 2016-01-01, first posted 2014-06-04, last updated 2016-01-07
Locations	3 sites in Netherlands

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Sliding scale insulin	Active comparator	Drug: Sliding scale insulin; Behavioral: Dietary advice; Drug: Glucose lowering medication; Drug: Chemotherapy	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
Intermediate acting insulin	Experimental	Drug: Intermediate acting 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)

Sliding scale insulin (Drug), also known as Short acting insulin on a sliding scale base
Intermediate acting insulin (Drug), also known as NPH insulin, insulatard
Dietary advice (Behavioral): Dietary advice to avoid food products with high glycemic index / high glucose load
Glucose lowering medication (Drug): Regular glucose lowering medication as prescribed by the patient's own physician before study entry
Chemotherapy (Drug), also known as Antineoplastic therapy: Chemotherapy (containing glucocorticoids) as prescribed by the patient's own physician

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (3)

Facility	City	Country
Slotervaart Hospital	Amsterdam	Netherlands
Antoni van Leeuwenhoek hospital	Amsterdam	Netherlands
Isala Clinics	Zwolle	Netherlands