Clinical trial NCT02144441: Pilot Study of Clinician-supported Patient Self-management of Hospital Insulin Therapy
Official title: Proof-of-concept Trial of Clinician-supported Patient Self-management of Hospital Insulin Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Insulin
Self Administration
Patient Satisfaction
Glucose
Hypoglycemia
Hyperglycemia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Trial feasibility metric: number of screened patients
timeFrame: 3 months
measure: Trial feasibility metric: number of eligible patients
timeFrame: 3 months
measure: Trial feasibility metric: number of patients approached for consent
timeFrame: 3 months
measure: Trial feasibility metric: proportion of eligible patients not consenting
timeFrame: 3 months
measure: Trial feasibility metric: reasons for non-consent
timeFrame: 3 months
measure: Trial feasibility metric: characteristics of consenting subjects and non-consenting patients
timeFrame: 3 months
measure: Trial feasibility metric: proportion of enrolled subjects completing the intervention
timeFrame: 3 months
measure: Trial feasibility metric: proportion of enrolled subjects disenrolling
timeFrame: 3 months
measure: Trial feasibility metric: reasons for disenrollment
timeFrame: 3 months
Secondary outcomes:
measure: Hyperglycemia
timeFrame: During hospitalization (maximum length 7 days)
measure: Patient satisfaction
timeFrame: At the end of hospitalization (maximum length 7 days)
measure: Hypoglycemia
timeFrame: During hospitalization (maximum length 7 days)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Perelman School of Medicine at the University of Pennsylvania
name: Sean Hennessy, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.