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

Diabetes Mellitus Clinical Trial

Official title:

Proof-of-concept Trial of Clinician-supported Patient Self-management of Hospital Insulin Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02144441
• Other study ID #: 819840
• Status: Withdrawn
• Phase: N/A
• First received: May 13, 2014
• Last updated: March 13, 2015
• Start date: June 2014
• Est. completion date: October 2014

Study information

• Verified date: May 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trial feasibility metric: number of screened patients		3 months	No
Primary	Trial feasibility metric: number of eligible patients		3 months	No
Primary	Trial feasibility metric: number of patients approached for consent		3 months	No
Primary	Trial feasibility metric: proportion of eligible patients not consenting		3 months	No
Primary	Trial feasibility metric: reasons for non-consent		3 months	No
Primary	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	No
Primary	Trial feasibility metric: proportion of enrolled subjects completing the intervention		3 months	No
Primary	Trial feasibility metric: proportion of enrolled subjects disenrolling		3 months	No
Primary	Trial feasibility metric: reasons for disenrollment		3 months	No
Secondary	Hyperglycemia	Frequency of blood glucose concentrations that are hyperglycemic (> 180 mg/dL)	During hospitalization (maximum length 7 days)	No
Secondary	Patient satisfaction	Satisfaction with inpatient diabetes care, as measured by the Diabetes Treatment Satisfaction Questionnaire for Inpatients (DTSQ-IP) adapted for use in the United States	At the end of hospitalization (maximum length 7 days)	No
Secondary	Hypoglycemia	Frequency of hypoglycemia (blood glucose concentration < 70 mg/dL) and frequency of severe hypoglycemia (blood glucose concentration < 40 mg/dL)	During hospitalization (maximum length 7 days)	Yes