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

Withdrawn before enrolling · Not applicable

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02144441

Run by

University of Pennsylvania

People needed

0

Starts

2014-06-01

Expected to finish

2014-10-01

Last updated by the study team

2015-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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