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

Primary Purpose

Lymphoma, Diabetes Mellitus, Type 2, Hyperglycemia

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Insulin protocol
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Steroid induced hyperglycemia, Glucocorticoid induced hyperglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Washington University in St. Louis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulin protocol

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Remission of primary oncologic diagnosis at one year

Full Information

First Posted
December 2, 2013
Last Updated
May 4, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02012465
Brief Title
Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Patients
Official Title
Validation of Insulin Protocol for Prevention and Management of Hyperglycemia in Oncology Patients With Diabetes Receiving High Dose Glucocorticoid Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Diabetes Mellitus, Type 2, Hyperglycemia
Keywords
Steroid induced hyperglycemia, Glucocorticoid induced hyperglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Insulin protocol
Other Intervention Name(s)
NPH, Glargine, Lispro
Intervention Description
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).
Primary Outcome Measure Information:
Title
Incidence of hyperglycemia
Description
Defined as blood glucose > 180 mg/dL. This will be measured as the % of patient-days with a blood sugar > 180 mg/dL.
Time Frame
up to 5 days of hospital course
Secondary Outcome Measure Information:
Title
Incidence of severe hyperglycemia
Description
Defined as blood glucose > 299 mg/dL. This will be measured as the % of patient-days with a blood sugar > 299 mg/dL.
Time Frame
up to 5 days of hospital course
Title
Incidence of hypoglycemia
Description
Defined as blood glucose < 70 mg/dL. This will be measured as the % of patient-days with a blood sugar < 70 mg/dL.
Time Frame
up to 5 days of hospital course
Title
Incidence of severe hypoglycemia
Description
Defined as blood glucose < 40 mg/dL. This will be measured as the % of patient-days with a blood sugar < 40 mg/dL.
Time Frame
up to 5 days of hospital course
Title
Remission of primary oncologic diagnosis at one year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garry Tobin, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna Roshal, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

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

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