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

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ClinicalTrials.gov Identifier: NCT02144441
Recruitment Status : Withdrawn (Very few patients met eligibility criteria, none of whom elected to enroll.)
First Posted : May 22, 2014
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: glargine and aspart Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Proof-of-concept Trial of Clinician-supported Patient Self-management of Hospital Insulin Therapy
Study Start Date : June 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient self-administered insulin
The study's only arm
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.




Primary Outcome Measures :
  1. Trial feasibility metric: number of screened patients [ Time Frame: 3 months ]
  2. Trial feasibility metric: number of eligible patients [ Time Frame: 3 months ]
  3. Trial feasibility metric: number of patients approached for consent [ Time Frame: 3 months ]
  4. Trial feasibility metric: proportion of eligible patients not consenting [ Time Frame: 3 months ]
  5. Trial feasibility metric: reasons for non-consent [ Time Frame: 3 months ]
  6. Trial feasibility metric: characteristics of consenting subjects and non-consenting patients [ Time Frame: 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

  7. Trial feasibility metric: proportion of enrolled subjects completing the intervention [ Time Frame: 3 months ]
  8. Trial feasibility metric: proportion of enrolled subjects disenrolling [ Time Frame: 3 months ]
  9. Trial feasibility metric: reasons for disenrollment [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Hyperglycemia [ Time Frame: During hospitalization (maximum length 7 days) ]
    Frequency of blood glucose concentrations that are hyperglycemic (> 180 mg/dL)

  2. Patient satisfaction [ Time Frame: 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

  3. Hypoglycemia [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144441


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Sean Hennessy, PharmD, PhD Perelman School of Medicine at the University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02144441     History of Changes
Other Study ID Numbers: 819840
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: May 2014
Keywords provided by University of Pennsylvania:
Diabetes Mellitus
Insulin
Self Administration
Patient Satisfaction
Glucose
Hypoglycemia
Hyperglycemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs