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

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Patient self-administered insulin	glargine and aspart	The study's only arm

Primary Outcome Measures

Name	Time	Method
Trial feasibility metric: proportion of enrolled subjects disenrolling	3 months
Trial feasibility metric: reasons for disenrollment	3 months
Trial feasibility metric: number of patients approached for consent	3 months
Trial feasibility metric: reasons for non-consent	3 months
Trial feasibility metric: proportion of enrolled subjects completing the intervention	3 months
Trial feasibility metric: proportion of eligible patients not consenting	3 months
Trial feasibility metric: number of screened patients	3 months
Trial feasibility metric: number of eligible patients	3 months
Trial feasibility metric: characteristics of consenting subjects and non-consenting patients	3 months	To examine baseline demographics and clinical factors, such as: mean age, median age, proportion female sex, other demographics, proportion with type I diabetes, proportion with type II diabetes, hemoglobin A1c on admission, reasons for admission

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	At the end of hospitalization (maximum length 7 days)	Satisfaction with inpatient diabetes care, as measured by the Diabetes Treatment Satisfaction Questionnaire for Inpatients (DTSQ-IP) adapted for use in the United States
Hypoglycemia	During hospitalization (maximum length 7 days)	Frequency of hypoglycemia (blood glucose concentration \< 70 mg/dL) and frequency of severe hypoglycemia (blood glucose concentration \< 40 mg/dL)
Hyperglycemia	During hospitalization (maximum length 7 days)	Frequency of blood glucose concentrations that are hyperglycemic (\> 180 mg/dL)

Recruitment & Eligibility