Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Insulin, Self Administration, Patient Satisfaction, Glucose, Hypoglycemia, Hyperglycemia
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.
Interventions
DRUGglargine 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.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trial feasibility metric: reasons for disenrollment | 3 months | — |
| Trial feasibility metric: characteristics of consenting subjects and non-consenting patients | 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 |
| 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: 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 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 |
| Hypoglycemia | 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) |
| Hyperglycemia | During hospitalization (maximum length 7 days) | Frequency of blood glucose concentrations that are hyperglycemic (\> 180 mg/dL) |
Countries
United States
Outcome results
None listed