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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
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.
Northwestern Memorial Hospital
Chicago, Illinois, United States
Mean glucose levels
Mean glucose levels based on home glucose meter and outpatient laboratory data post-discharge
Time frame: 30 days
Number of hypoglycemic episodes
Number of glucoses \< 70 mg/dl
Time frame: 14, 30 and 90 days
Number of hyperglycemic episodes
Number of blood glucose levels \>200 mg/dL
Time frame: 14, 30 and 90 days
Healthcare utilization
Number of post-discharge contacts with the healthcare system (i.e. phone calls, emergency room visits, re-admissions, outpatient clinician visits).
Time frame: 14, 30 and 90 days
HbA1c
Hemoglobin A1c blood test
Time frame: 90 days
Time in hyperglycemia
Time in hyperglycemia defined as \> 200 mg/dl, outcome from continuous glucose monitor placement
Time frame: 14 days
Time in hypoglycemia
Time in hyperglycemia defined as \< 70 mg/dl, outcome from continuous glucose monitor placement
Time frame: 14 days
Mean amplitude of glycemic excursion
MAGE, outcome from continuous glucose monitor placement
Time frame: 14 days
Glycemic variability
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
A continuous glucose monitor will be used to monitor glucose levels from discharge to 14 days post discharge.
Time frame: 14 days
Diabetes Symptoms Questionnaire
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.
Time frame: 14 days, 30 days
Summary of Diabetes Self Care Activities
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.
Time frame: 14 days, 30 days
Diabetes Distress Scale
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.
Time frame: 14 days, 30 days
Hospital Consumer Assessment of Healthcare Providers and Systems
Patient satisfaction survey
Time frame: 14 days, 30 days
Partner Diabetes Distress Scale
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.
Time frame: Baseline, 30 days, 90 days
Perceived Stress Scale
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.
Time frame: Baseline, 30 days, 90 days
Infection
Rate of infection (bacterial, viral, other)
Time frame: 30 and 90 days