Pilot Study of Clinician-supported Patient Self-management of Hospital Insulin Therapy

NCT ID: NCT02144441

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-10-31

Brief Summary

This study will examine the feasibility of implementing a clinician-supported patient self-managed inpatient insulin intervention. It will: assess the number of eligible patients presenting over time; assess patients' willingness to enroll; assess patients' ability to successfully complete the intervention; examine occurrences of hyperglycemia and hypoglycemia; and assess patients' satisfaction with inpatient diabetes care.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient self-administered insulin

The study's only arm

Group Type: EXPERIMENTAL

glargine and aspart

Intervention Type: DRUG

Inpatient will administer hospital-dispensed basal-bolus insulin (glargine and aspart) according to a regimen developed in collaboration with the diabetes consult service.

Interventions

glargine and aspart

Inpatient will administer hospital-dispensed basal-bolus insulin (glargine and aspart) according to a regimen developed in collaboration with the diabetes consult service.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Admitted to the Hospital of the University of Pennsylvania (HUP) in the past 72 hours.
• Current HUP locations are Founders 12, Founders 14, Silverstein 11, and Rhoads 1.
• Age 18 years or older.
• Type-1 or type-2 diabetes mellitus requiring home basal-bolus insulin therapy administered via subcutaneous injection (not pump).
• Patient manages own basal-bolus insulin therapy at home without assistance, including measuring own blood glucose (at least at mealtimes) and administering own subcutaneous insulin.
• Patient is willing to use the following insulin products: rapid-acting insulin aspart via insulin pen (NovoLog) and long-acting insulin glargine via vial and syringe (Lantus).
• Most recent hemoglobin A1c was measured within past 6 months and was <7.5%.
• Active order for in-hospital basal-bolus or sliding-scale insulin.
• Patient is willing and able to record their self-measured blood glucose results, doses of insulin that they self-administer, a food journal, and exercise log.
• Clinical care team agrees with study inclusion.

Exclusion Criteria

• Inpatient order for insulin via subcutaneous infusion (i.e., pump) or intravenous infusion (i.e., drip).
• Inability to perform the activities required by the trial.
• Primary reason for admission was hyperglycemia, hypoglycemia, diabetic ketoacidosis, hyperglycemic hyperosmolar nonketotic coma, a psychiatric condition, acute alcohol poisoning, or acute drug ingestion.
• Order for a newly-prescribed or increased dose of a previously-prescribed corticosteroid.
• Enteral or parenteral nutrition.
• Expected length of stay <48h, as determined by treating physician.
• At risk for self-harm, as determined by 1-to-1 status placement.
• Pregnant, as recorded on medical record.
• Cannot understand, speak, and read English.
• Patient does not wish to utilize Novolog and Lantus while in the hospital.
• Prior enrollment in this trial.
• Do not resuscitate status.
• Inability to give written informed consent.
• Clinical care team disagrees with study inclusion.
• Patient has limited mobility such that they cannot safely access the bedside medication lockbox.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Hennessy, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

Perelman School of Medicine at the University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Acton EK, Leonard CE, Schutta MH, Cardillo S, Troxel AB, Trotta R, Hennessy S. Challenges in recruiting subjects to a pilot trial of patient-managed in-hospital insulin. BMC Res Notes. 2015 Oct 1;8:523. doi: 10.1186/s13104-015-1480-6.

Reference Type: DERIVED

PMID: 26429339 (View on PubMed)

Other Identifiers

819840

Identifier Type: -

Identifier Source: org_study_id