Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Validation of Insulin Protocol for Prevention and Management of Hyperglycemia in Oncology Patients With Diabetes Receiving High Dose Glucocorticoid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012465
• Other study ID #: 201306071
• Status: Completed
• Phase: Early Phase 1
• Start date: September 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are no guidelines for the management of glucocorticoid- (henceforth steroid) induced elevated blood sugars (henceforth hyperglycemia). Oncology ward patients have particularly high rates of hyperglycemia and are frequently exposed to high dose steroid therapy. A prior study by Muthala et al. (unpublished data) found a relationship between insulin requirements needed to maintain normal blood sugars, patient weight, and mg of steroid administered. In this pilot study, through an endocrine consult team, a weight-based, steroid dose-based insulin protocol will be implemented for the management of hyperglycemia in lymphoma patients requiring high dose steroid therapy, with the goal of reducing hyperglycemia incidence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For diabetics enrolled on admission:

Inclusion Criteria:

• Age = 18 years old

• Type 2 diabetes mellitus treated with insulin secretagogues or insulin prior to hospitalization

• Diagnosis of lymphoma

• Plan to treat with steroids of minimum equivalent of 20 mg prednisone per day

• Hospitalized for at least 48 hours

• Decision-making capacity to provide own consent

Exclusion Criteria:

• Type 1 diabetes

• Any contraindication to insulin therapy

• Patients only on single agent therapy such as metformin, thiazolidinediones (TZDs), Dipeptidyl peptidase-4 (DPP4) inhibitors, or Exenatide®, for safety concerns

• Insulin requirement of >1.5 units of insulin/kg

• If a patient required ICU stay during the hospitalization, data from 12 hours before, during, and 12 hours after ICU stay will be omitted to avoid confounding of the effect of critical illness on glycemic control

• Pregnancy, confirmed with a urine b-human chorionic gonadotropin (HCG) (for all women between the age of 18 and 60 years old)

Patients who develop a blood glucose > 235 mg/dL after admission will be eligible for study enrollment based on the following:

Inclusion criteria:

• Age = 18 years old

• Diagnosis of lymphoma

• Plan to treat with steroids of minimum equivalent of 20 mg prednisone per day

• Will be hospitalized for at least an additional 48 hours

• Decision-making capacity to provide own consent

Exclusion criteria:

• Any contraindication to insulin therapy

• If a patient required ICU stay during the hospitalization, data from 12 hours before, during, and 12 hours after ICU stay will be omitted to avoid confounding of the effect of critical illness on glycemic control

• Pregnancy, confirmed with a urine b-HCG (for all women between the age of 18 and 60 years old)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Lymphoma

Intervention

Biological:
• Insulin protocol
Within 24 hours of admission for diabetic participants, the inpatient oncology team will consult the endocrine team to apply the following part of the protocol, confirm NPH insulin dosing, and ensure that oral hypoglycemics are held. The following basal-bolus protocol is standard of care for inpatient diabetics requiring insulin at Barnes Jewish Hospital. The alternative practice has been to use 60-80% of the home insulin regimen while patients are hospitalized. For patients using home insulin, the admitting oncology team will enact one of these methods while awaiting the endocrine service's formal recommendations. Determine basal-bolus insulin requirement for the patient based on body weight: Patient weight (kg) x 0.5-0.7 Units/kg = Units of total insulin per 24 hours The TDD can be divided into 50% basal (glargine) and 50% meal time (lispro) insulin, plus sliding scale insulin (lispro).

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hyperglycemia	Defined as blood glucose > 180 mg/dL. This will be measured as the % of patient-days with a blood sugar > 180 mg/dL.	up to 5 days of hospital course
Secondary	Incidence of severe hyperglycemia	Defined as blood glucose > 299 mg/dL. This will be measured as the % of patient-days with a blood sugar > 299 mg/dL.	up to 5 days of hospital course
Secondary	Incidence of hypoglycemia	Defined as blood glucose < 70 mg/dL. This will be measured as the % of patient-days with a blood sugar < 70 mg/dL.	up to 5 days of hospital course
Secondary	Incidence of severe hypoglycemia	Defined as blood glucose < 40 mg/dL. This will be measured as the % of patient-days with a blood sugar < 40 mg/dL.	up to 5 days of hospital course
Secondary	Remission of primary oncologic diagnosis at one year		1 year