Diabetes Toolkit at Discharge

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Implementation and Testing of a Diabetes Discharge Intervention to Improve Safety During Transitions of Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05663931
• Other study ID #: STU00216291
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Stefanie Herrmann, MS
• Phone: 312-503-0191
• Email: s-herrmann[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Insulin Dependent Diabetes

Intervention

Other:
• DM 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.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean glucose levels	Mean glucose levels based on home glucose meter and outpatient laboratory data post-discharge	30 days
Secondary	Number of hypoglycemic episodes	Number of glucoses < 70 mg/dl	14, 30 and 90 days
Secondary	Number of hyperglycemic episodes	Number of blood glucose levels >200 mg/dL	14, 30 and 90 days
Secondary	Healthcare utilization	Number of post-discharge contacts with the healthcare system (i.e. phone calls, emergency room visits, re-admissions, outpatient clinician visits).	14, 30 and 90 days
Secondary	HbA1c	Hemoglobin A1c blood test	90 days
Secondary	Time in hyperglycemia	Time in hyperglycemia defined as > 200 mg/dl, outcome from continuous glucose monitor placement	14 days
Secondary	Time in hypoglycemia	Time in hyperglycemia defined as < 70 mg/dl, outcome from continuous glucose monitor placement	14 days
Secondary	Mean amplitude of glycemic excursion	MAGE, outcome from continuous glucose monitor placement	14 days
Secondary	Glycemic variability	A continuous glucose monitor will be used to monitor glucose levels from discharge to 14 days post discharge.	14 days
Secondary	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.	14 days, 30 days
Secondary	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.	14 days, 30 days
Secondary	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.	14 days, 30 days
Secondary	Hospital Consumer Assessment of Healthcare Providers and Systems	Patient satisfaction survey	14 days, 30 days
Secondary	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.	Baseline, 30 days, 90 days
Secondary	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.	Baseline, 30 days, 90 days
Secondary	Infection	Rate of infection (bacterial, viral, other)	30 and 90 days