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Very few patients met eligibility criteria, none of whom elected to enroll.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient self-administered insulin | Experimental | The study's only arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperglycemia | Frequency of blood glucose concentrations that are hyperglycemic (> 180 mg/dL) | During hospitalization (maximum length 7 days) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Hennessy, PharmD, PhD | Perelman School of Medicine at the University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26429339 | Derived | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| D017060 | Patient Satisfaction |
| D007003 | Hypoglycemia |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| At the end of hospitalization (maximum length 7 days) |
| 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) |
| D006946 | Hyperinsulinism |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |