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

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02012465

Collaborator

(none)

Enrollment

Location

Arm

19.9

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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 (unpublished data) found a relationship between insulin requirements needed to maintain normal blood sugars, patient weight, and mg of steroid administered.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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Diabetes Mellitus, Type 2 Hyperglycemia	Biological: Insulin protocol	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insulin protocol 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 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). Other Names: NPH Glargine Lispro

Arm

Intervention/Treatment

Experimental: Insulin protocol

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

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).

Other Names:

NPH

Glargine

Lispro

Outcome Measures

Primary Outcome Measures

Incidence of hyperglycemia [up to 5 days of hospital course]
Defined as blood glucose > 180 mg/dL. This will be measured as the % of patient-days with a blood sugar > 180 mg/dL.

Secondary Outcome Measures

Incidence of severe hyperglycemia [up to 5 days of hospital course]
Defined as blood glucose > 299 mg/dL. This will be measured as the % of patient-days with a blood sugar > 299 mg/dL.
Incidence of hypoglycemia [up to 5 days of hospital course]
Defined as blood glucose < 70 mg/dL. This will be measured as the % of patient-days with a blood sugar < 70 mg/dL.
Incidence of severe hypoglycemia [up to 5 days of hospital course]
Defined as blood glucose < 40 mg/dL. This will be measured as the % of patient-days with a blood sugar < 40 mg/dL.
Remission of primary oncologic diagnosis at one year [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University in St. Louis	Saint Louis	Missouri	United States	63108

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator: Garry Tobin, MD, Washington University School of Medicine
Principal Investigator: Anna Roshal, MD, Washington University School of Medicine