Diabetes Toolkit at Discharge

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Insulin Dependent Diabetes
• Intervention / Treatment: Other: DM Discharge Toolkit

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefanie Herrmann, MS; Phone Number: 312-503-0191; Email: s-herrmann@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Memorial Hospital
      • Contact: Amisha Wallia, MD; Phone Number: 312-503-2756; Email: a-wallia@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DM Discharge Toolkit; Up to 60 participants will be recruited for the intervention group. Participants will receive the current standard of care DM education for insulin at Northwestern Memorial Hospital and the adjunctive education with the DM Discharge Toolkit.	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.
No Intervention: Current Standard of Care Discharge DM Training; Up to 60 participants will be recruited for the control group. Participants will receive the current standard of care DM education for insulin use during current discharge care processes at Northwestern Memorial Hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean glucose levels	Mean glucose levels based on home glucose meter and outpatient laboratory data post-discharge	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hypoglycemic episodes	Number of glucoses < 70 mg/dl	14, 30 and 90 days
Number of hyperglycemic episodes	Number of blood glucose levels >200 mg/dL	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).	14, 30 and 90 days
HbA1c	Hemoglobin A1c blood test	90 days
Time in hyperglycemia	Time in hyperglycemia defined as > 200 mg/dl, outcome from continuous glucose monitor placement	14 days
Time in hypoglycemia	Time in hyperglycemia defined as < 70 mg/dl, outcome from continuous glucose monitor placement	14 days
Mean amplitude of glycemic excursion	MAGE, outcome from continuous glucose monitor placement	14 days
Glycemic variability	A continuous glucose monitor will be used to monitor glucose levels from discharge to 14 days post discharge.	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.	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.	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.	14 days, 30 days
Hospital Consumer Assessment of Healthcare Providers and Systems	Patient satisfaction survey	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.	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.	Baseline, 30 days, 90 days
Infection	Rate of infection (bacterial, viral, other)	30 and 90 days

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Amisha Wallia, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Insulin; Hospital discharge; Transitions of care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: STU00216291

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No