Diabetes Toolkit at Discharge

Not Applicable

Recruiting

• Conditions: Insulin Dependent Diabetes; Diabetes Mellitus, Type 2
• Interventions: Other: DM Discharge Toolkit

• Registration Number: NCT05663931
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-23
• Study Start: 2023-01-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-07-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DM Discharge Toolkit	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.

Primary Outcome Measures

Name	Time	Method
Mean glucose levels	30 days	Mean glucose levels based on home glucose meter and outpatient laboratory data post-discharge

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States