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

NCT02144441 | Withdrawn DMC

• 1 other identifier: 819840
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; Insulin; Self Administration; Patient Satisfaction; Glucose; Hypoglycemia; Hyperglycemia

Outcome Measures

Primary Outcomes (9)

• Trial feasibility metric: number of screened patients

  3 months

• Trial feasibility metric: number of eligible patients

  3 months

• Trial feasibility metric: number of patients approached for consent

  3 months

• Trial feasibility metric: proportion of eligible patients not consenting

  3 months

• Trial feasibility metric: reasons for non-consent

  3 months

• Trial feasibility metric: characteristics of consenting subjects and non-consenting patients

  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

  3 months

• Trial feasibility metric: proportion of enrolled subjects completing the intervention

  3 months

• Trial feasibility metric: proportion of enrolled subjects disenrolling

  3 months

• Trial feasibility metric: reasons for disenrollment

  3 months

Secondary Outcomes (3)

• Hyperglycemia

  During hospitalization (maximum length 7 days)

• Patient satisfaction

  At the end of hospitalization (maximum length 7 days)

• Hypoglycemia

  During hospitalization (maximum length 7 days)

Study Arms (1)

Patient self-administered insulin

EXPERIMENTAL

The study's only arm

Drug: glargine and aspart

Interventions

glargine and aspart DRUG

Inpatient will administer hospital-dispensed basal-bolus insulin (glargine and aspart) according to a regimen developed in collaboration with the diabetes consult service.

Patient self-administered insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.
• Patient has limited mobility such that they cannot safely access the bedside medication lockbox.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 26429339 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance; Patient Satisfaction; Hypoglycemia; Hyperglycemia

Interventions

Insulin Glargine; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Sean Hennessy, PharmD, PhD

  Perelman School of Medicine at the University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 22, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2014-05

Locations

US (1)