Inpatient Diabetes on Corticosteroids

NCT01970241 | Completed Phase 4 Results

• 1 other identifier: MMRF-13-3658
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Keywords

corticosteroid; diabetes; insulin

Outcome Measures

Primary Outcomes (1)

• Mean POC Glucose Level Between Groups

  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.

  Assessed from enrollment to discharge or enrollment to day five.

Secondary Outcomes (1)

• Episodes of Hypoglycemia Between NPH and Control Groups

  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.

Other Outcomes (16)

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

  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.

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

  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.

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

  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.

Study Arms (2)

NPH with steroid dose

EXPERIMENTAL

Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg

Drug: NPH; Drug: Correction Factor

Control - Background and correction insulin

ACTIVE COMPARATOR

Receive usual care with background insulin and correction factor for duration of study (2-5 days)

Drug: Correction Factor

Interventions

NPH DRUG

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

Also known as: NPH Lilly Insulin

NPH with steroid dose

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.

Also known as: Rapid acting regular insulin

Control - Background and correction insulin; NPH with steroid dose

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

• Khowaja A, Alkhaddo JB, Rana Z, Fish L. Glycemic Control in Hospitalized Patients with Diabetes Receiving Corticosteroids Using a Neutral Protamine Hagedorn Insulin Protocol: A Randomized Clinical Trial. Diabetes Ther. 2018 Aug;9(4):1647-1655. doi: 10.1007/s13300-018-0468-3. Epub 2018 Jun 30.

  PMID: 29961246 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Results Point of Contact

• Title: Lisa Fish MD
• Organization: HCMC

lisa.fish@hcmed.org

612-873-2705

Study Officials

• Lisa Fish, MD

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: October 28, 2013
• Study Start: July 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 1, 2019
• Results First Posted: October 1, 2019

Record last verified: 2019-09

Locations

US (1)