Proof-of-concept Trial of Clinician-supported Patient Self-management of Hospital Insulin Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Trial feasibility metric: proportion of enrolled subjects disenrolling
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Patient self-administered insulin
The study's only arm
干预措施: glargine and aspart (Drug)
结局指标
主要结局
Trial feasibility metric: proportion of enrolled subjects disenrolling
时间窗: 3 months
Trial feasibility metric: number of patients approached for consent
时间窗: 3 months
Trial feasibility metric: reasons for non-consent
时间窗: 3 months
Trial feasibility metric: proportion of enrolled subjects completing the intervention
时间窗: 3 months
Trial feasibility metric: proportion of eligible patients not consenting
时间窗: 3 months
Trial feasibility metric: number of screened patients
时间窗: 3 months
Trial feasibility metric: number of eligible patients
时间窗: 3 months
Trial feasibility metric: characteristics of consenting subjects and non-consenting patients
时间窗: 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: reasons for disenrollment
时间窗: 3 months
次要结局
- Patient satisfaction(At the end of hospitalization (maximum length 7 days))
- Hypoglycemia(During hospitalization (maximum length 7 days))
- Hyperglycemia(During hospitalization (maximum length 7 days))