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NCT Number: NCT01970241

Inpatient Diabetes on Corticosteroids

Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen. Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay. The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

About this study

As above.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Prior history of diabetes
  • Able to provide informed consent
  • Receiving corticosteroids while hospitalized of greater than 10 mg/d prednisone or the equivalent of dexamethasone or methylprednisolone
  • Expect to be hospitalized for 48 hours

Exclusion criteria

  • Renal failure with GFR (glomerular filtration rate) < 30 ml/min/1.73m2
  • ALT (alanine aminotransferase) > 2 times upper normal for laboratory

Treatment and study plan

NPH

Drug

NPH given per study table based on steroid dose and patient weight in kg.

Other names: NPH Lilly Insulin

Correction Factor

Drug

Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.

Other names: Rapid acting regular insulin

Primary outcomes

  1. Mean POC Glucose Level Between Groups

    Time frame: Assessed from enrollment to discharge or enrollment to day five.

    Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention. Values shown are the overall mean point of care blood glucose.

Secondary outcomes

  1. Episodes of Hypoglycemia Between NPH and Control Groups

    Time frame: Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.

    Hypoglycemia was defined as point of care glucose less than 70 mg/dL.

Other outcomes

  1. Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL

    Time frame: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.

    Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements between 70 - 180 mg/dl.

  2. Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL

    Time frame: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.

    Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 180 - 300 mg/dL.

  3. Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl

    Time frame: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.

    Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 300 - 400 mg/dl.

  4. Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL

    Time frame: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.

    Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements > 400 mg/dL.

  5. Difference in Length of Stay Between NPH and Control Group

    Time frame: Measured from the day of admission till the day of discharge

    Time difference of hospitalization between the NPH and control groups.

  6. Mean Point of Care (POC) Glucose Level in Both Groups.

    Time frame: On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.

    The overall mean point of care glucose levels in the NPH group and control group on the first day of the study.

  7. Mean Point of Care (POC) Glucose Level in Both Groups.

    Time frame: On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.

    The overall mean point of care glucose levels in the NPH group and control group on the last day of the study.

  8. Correlation of C-peptide With Age

    Time frame: plasma C-peptide was measured once at the time of enrollment

  9. Correlation of C-peptide With BMI

    Time frame: Measured once at the time of enrollment

  10. Correlation of C-peptide With eGFR

    Time frame: Measured once at the time of enrollment

  11. Correlation of C-peptide With Serum Creatinine

    Time frame: Measured once at the time of enrollment

  12. Correlation of C-peptide With ALT

    Time frame: Measured once at the time of enrollment

  13. Correlation of C-peptide With Hemoglobin A1c

    Time frame: Measured once at the time of enrollment

  14. Correlation of C-peptide With Duration of Diabetes

    Time frame: Measured once at the time of enrollment

  15. Correlation of C-peptide With Plasma Glucose

    Time frame: Measured the time of enrollment

  16. Correlation of C-peptide With Length of Stay

    Time frame: Measured once at the time of enrollment

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2013
Registry last updated
Oct 1, 2019

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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