Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatment glargine and aspart
Sponsor University of Pennsylvania
Start date June 2014
End date December 2014
Trial size 25 participants
Trial identifier NCT02144441, 819840

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
The study's only arm
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.

Primary Outcomes

Measure
Trial feasibility metric: number of screened patients
time frame: 3 months
Trial feasibility metric: number of eligible patients
time frame: 3 months
Trial feasibility metric: number of patients approached for consent
time frame: 3 months
Trial feasibility metric: proportion of eligible patients not consenting
time frame: 3 months
Trial feasibility metric: reasons for non-consent
time frame: 3 months
Trial feasibility metric: characteristics of consenting subjects and non-consenting patients
time frame: 3 months
Trial feasibility metric: proportion of enrolled subjects completing the intervention
time frame: 3 months
Trial feasibility metric: proportion of enrolled subjects disenrolling
time frame: 3 months
Trial feasibility metric: reasons for disenrollment
time frame: 3 months

Secondary Outcomes

Measure
Hyperglycemia
time frame: During hospitalization (maximum length 7 days)
Patient satisfaction
time frame: At the end of hospitalization (maximum length 7 days)
Hypoglycemia
time frame: During hospitalization (maximum length 7 days)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Proof-of-concept Trial of Clinician-supported Patient Self-management of Hospital Insulin Therapy
Principal investigator Sean Hennessy, PharmD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by University of Pennsylvania.