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Completed

NCT Number: NCT02012465

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

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 (unpublished data) found a relationship between insulin requirements needed to maintain normal blood sugars, patient weight, and mg of steroid administered.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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Other names: NPH, Glargine, Lispro

Primary outcomes

  1. Incidence of hyperglycemia

    Time frame: 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 outcomes

  1. Incidence of severe hyperglycemia

    Time frame: 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.

  2. Incidence of hypoglycemia

    Time frame: 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.

  3. Incidence of severe hypoglycemia

    Time frame: 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.

  4. Remission of primary oncologic diagnosis at one year

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 16, 2013
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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