Diabetes Mellitus, Type 2, Insulin Dependent Diabetes
Conditions
Keywords
Insulin, Hospital discharge, Transitions of care
Brief summary
The purpose of this randomized clinical trial is to implement the DM Discharge Toolkit into hospital discharge and assess the effect of the DM Discharge Toolkit on patients newly requiring insulin.
Detailed description
This study is a randomized controlled trial with a parallel group design of up to 120 study participants in a 1:1 ratio to receive either current standard of care discharge DM training (control) or current standard of care discharge DM training and the DM Discharge Toolkit (intervention) before or immediately after being sent home to assume self-DM care with insulin.
Interventions
OTHERDM Discharge Toolkit
The DM Discharge Toolkit is a multi-modal intervention consisting of a 3-D printed DM survival "kit" that stores DM self-care supplies (e.g., glucose meter) and technical skills (e.g., injection) simulation materials (e.g. simulation skin), whose use is integrated with a website (https://mydiabeteskit.com) containing standardized DM "Survival" education content.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* English speaking patients * 18 years of age and older * Expected survival \>90 days * Need for new insulin at time of hospital discharge
Exclusion criteria
* Patients with the inability to give informed consent * Non-English speaking * Not diagnosed with diabetes * Not been newly prescribed insulin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean glucose levels | 30 days | Mean glucose levels based on home glucose meter and outpatient laboratory data post-discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of hypoglycemic episodes | 14, 30 and 90 days | Number of glucoses \< 70 mg/dl |
| Number of hyperglycemic episodes | 14, 30 and 90 days | Number of blood glucose levels \>200 mg/dL |
| Healthcare utilization | 14, 30 and 90 days | Number of post-discharge contacts with the healthcare system (i.e. phone calls, emergency room visits, re-admissions, outpatient clinician visits). |
| HbA1c | 90 days | Hemoglobin A1c blood test |
| Time in hyperglycemia | 14 days | Time in hyperglycemia defined as \> 200 mg/dl, outcome from continuous glucose monitor placement |
| Time in hypoglycemia | 14 days | Time in hyperglycemia defined as \< 70 mg/dl, outcome from continuous glucose monitor placement |
| Mean amplitude of glycemic excursion | 14 days | MAGE, outcome from continuous glucose monitor placement |
| Glycemic variability | 14 days | A continuous glucose monitor will be used to monitor glucose levels from discharge to 14 days post discharge. |
| Diabetes Symptoms Questionnaire | 14 days, 30 days | The Diabetes Symptoms Questionnaire consists of 9 questions where patients answer on a scale between 1-5, with higher numbers indicating a greater rate of occurrence. |
| Summary of Diabetes Self Care Activities | 14 days, 30 days | The Summary of Diabetes Self Care Activities consists of 7 questions where patients tally the number of days in the past week that they performed various diabetes self care tasks, such as checking blood glucose and taking medications. |
| Diabetes Distress Scale | 14 days, 30 days | The Diabetes Distress Scale is a questionnaire with 17 questions where patients answer on a scale between 1-6, with higher numbers indicating higher distress related to diabetes diagnosis. |
| Hospital Consumer Assessment of Healthcare Providers and Systems | 14 days, 30 days | Patient satisfaction survey |
| Partner Diabetes Distress Scale | Baseline, 30 days, 90 days | The Partner Diabetes Distress Scale is a questionnaire with 21 questions where a spouse or partner of someone with diabetes answers on a scale between 0-4, with higher numbers indicating higher distress related to partner's diabetes diagnosis. |
| Perceived Stress Scale | Baseline, 30 days, 90 days | The Perceived Stress Scale is a questionnaire with 10 questions where a patient answers on a scale between 0-4 with higher numbers indicating a greater rate of occurrence. |
| Infection | 30 and 90 days | Rate of infection (bacterial, viral, other) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmisha Wallia, MD
Northwestern University
Outcome results
None listed