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

NCT02012465 | Completed Early Phase 1 DMC

• 1 other identifier: 201306071
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 (unpublished data) found a relationship between insulin requirements needed to maintain normal blood sugars, patient weight, and mg of steroid administered.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.

Conditions

Lymphoma; Diabetes Mellitus, Type 2; Hyperglycemia

Keywords

Steroid induced hyperglycemia; Glucocorticoid induced hyperglycemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of severe hyperglycemia

  up to 5 days of hospital course

• Incidence of hypoglycemia

  up to 5 days of hospital course

• Incidence of severe hypoglycemia

  up to 5 days of hospital course

• Remission of primary oncologic diagnosis at one year

  1 year

Study Arms (1)

Insulin protocol

EXPERIMENTAL

For diabetic patients, as part of the initial chemotherapy orders on admission, the following will be calculated by the primary oncologist to determine the amount of neutral protamine Hagedorn (NPH) insulin needed to cover steroid use in prednisone equivalents (all insulin in this study is to be administered subcutaneously): * Use 0.1 (mg of prednisone equivalent - 20)/20 x weight (kg) to estimate total insulin in 24 hours (Total daily dose (TDD)) * Total daily NPH dose will be divided equally based on the frequency of steroid administration, and given with each steroid dose. For nondiabetic participants with hyperglycemia recruited during admission, the inpatient oncology team will consult the endocrine team within 24 hours of eligibility for NPH dosing as above.

Biological: Insulin protocol

Interventions

Insulin protocol BIOLOGICAL

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).

Also known as: NPH, Glargine, Lispro

Insulin protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Lymphoma; Diabetes Mellitus, Type 2; Hyperglycemia

Interventions

Insulin Glargine; Insulin Lispro

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Garry Tobin, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Anna Roshal, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 16, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

US (1)