Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy

Hyperglycemia Steroid-induced Clinical Trial

— GluCon-Chemo  

Official title:

Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155374
• Other study ID #: NL47135.048.13
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2014
• Last updated: January 6, 2016
• Start date: May 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Slotervaart Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperglycemia Steroid-induced

Intervention

Drug:
• Sliding scale insulin

• Intermediate acting insulin

Behavioral:
• Dietary advice
Dietary advice to avoid food products with high glycemic index / high glucose load

Drug:
• Glucose lowering medication
Regular glucose lowering medication as prescribed by the patient's own physician before study entry
• Chemotherapy
Chemotherapy (containing glucocorticoids) as prescribed by the patient's own physician

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Slotervaart Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24h till end of treatment (expected duration 4-8 days)	No
Secondary	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)	At the end of each treatment cycle (expected duration 4-8 days)	No
Secondary	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.	During each treatment (expected duration 4-8 days)	No
Secondary	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	During each treatment (expected duration 4-8 days)	Yes