Hyperglycemia Steroid-inducedPhase 4GluCon-ChemoNCT02155374
Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy
A Phase 4 study testing Sliding scale insulin, Intermediate acting insulin and Dietary advice in people with Hyperglycemia Steroid-induced, run by Slotervaart Hospital at 3 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia Steroid-induced
- What is being tested?
- Sliding scale insulin, Intermediate acting insulin and Dietary advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesNetherlands
- Study dates
- May 2014to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of hypo-unawareness
- Continuous tube or parental feeding
- Continuous (maintenance) systemic glucocorticoid therapy
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Slotervaart Hospital
Amsterdam, 1066 EC
Antoni van Leeuwenhoek hospital
Amsterdam, 1066EC
Isala Clinics
Zwolle, 8025 AB
About this study
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.
Read more
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.
- Conditions
- Hyperglycemia Steroid-induced
- Being tested
- Sliding scale insulin, Intermediate acting insulin, Dietary advice, Glucose lowering medication, Chemotherapy
- Keywords
- Glucocorticoid induced hyperglycemia, insulin, chemotherapy
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sliding scale insulinDrug
Also called Short acting insulin on a sliding scale base
Intermediate acting insulinDrug
Also called NPH insulin, insulatard
Dietary adviceBehavioural
Dietary advice to avoid food products with high glycemic index / high glucose load
Glucose lowering medicationDrug
Regular glucose lowering medication as prescribed by the patient's own physician before study entry
ChemotherapyDrug
Also called Antineoplastic therapy
Chemotherapy (containing glucocorticoids) as prescribed by the patient's own physician
| Study group | Role | What they receive |
|---|---|---|
| Sliding scale insulin | Active comparator | 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 Receives: Drug: Sliding scale insulin; Behavioral: Dietary advice; Drug: Glucose lowering medication; Drug: Chemotherapy |
| Intermediate acting insulin | Experimental | 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) Receives: Drug: Intermediate acting insulin; Behavioral: Dietary advice; Drug: Glucose lowering medication; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24h till end of treatment (expected duration 4-8 days)
Secondary outcomes (3)
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)
Measured: 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.
Measured: 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
Measured: During each treatment (expected duration 4-8 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycemia Steroid-inducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slotervaart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155374
- Sponsor's protocol ID
- NL47135.048.13
- Acronym
- GluCon-Chemo
- Status last verified
- Jan 2016
- First submitted
- 5 May 2014
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy
- ClinicalTrials.gov ID
- NCT02155374
- Acronym / sponsor ID
- GluCon-Chemo / NL47135.048.13
- Conditions
- Hyperglycemia Steroid-induced
- Keywords
- Glucocorticoid induced hyperglycemia, insulin, chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Slotervaart HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sliding scale insulin | Active comparator | Drug: Sliding scale insulin, Behavioral: Dietary advice, Drug: Glucose lowering medication, Drug: ChemotherapySliding 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: ChemotherapyIntermediate 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- History of hypo-unawareness
- Continuous tube or parental feeding
- Continuous (maintenance) systemic glucocorticoid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sliding scale insulinAlso: Short acting insulin on a sliding scale base | Drug | Sliding scale insulin |
| Intermediate acting insulinAlso: NPH insulin, insulatard | Drug | Intermediate acting insulin |
| Dietary adviceDietary advice to avoid food products with high glycemic index / high glucose load | Behavioural | Intermediate acting insulin, Sliding scale insulin |
| Glucose lowering medicationRegular glucose lowering medication as prescribed by the patient's own physician before study entry | Drug | Intermediate acting insulin, Sliding scale insulin |
| ChemotherapyAlso: Antineoplastic therapyChemotherapy (containing glucocorticoids) as prescribed by the patient's own physician | Drug | Intermediate acting insulin, Sliding scale insulin |
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
3 secondary outcomes
Patient satisfaction
Time frame: At the end of each treatment cycle (expected duration 4-8 days)
Clinical outcomes
Time frame: During each treatment (expected duration 4-8 days)
Hypoglycemia
Time frame: During each treatment (expected duration 4-8 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
Related trials for Hyperglycemia Steroid-induced
Active, not recruitingPhase 1/2
Pre-emptive Insulin to Prevent High Glucose After a Knee Steroid Injection in Adults With Type 2 Diabetes
Diabetes Mellitus, Type 2, Hyperglycemia Due to Type 2 Diabetes Mellitus
Not yet recruiting
CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial
Sudden Sensorineural Hearing Loss (SSNHL), Prediabetes / Type 2 Diabetes
RecruitingObservational study
Metabolic Control in Anesthesia and Surgery
Anesthesia, Continuous Glucose Monitoring
Enrolling by invitationObservational study
Predictive Factors and Monitoring Strategies in Steroid-Induced Diabetes
Steroid-Induced Diabetes, Diabete Type 2
Enrolling by invitationPhase 4
Evaluation of the Efficacy and Safety of GLP-1 Receptor Agonist Therapy In Steroid-Induced Diabetes
Steroid-Induced Diabetes, Steroid-Induced Hyperglycemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sliding scale insulin, Intermediate acting insulin and Dietary advice in people with Hyperglycemia Steroid-induced, run by Slotervaart Hospital at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: 24h till end of treatment (expected duration 4-8 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.