Overview

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

Status:
Withdrawn
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Pennsylvania
Treatments:
Insulin
Insulin Glargine
Insulin, Globin Zinc
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.