Diabetes Toolkit at Discharge
Implementation and Testing of a Diabetes Discharge Intervention to Improve Safety During Transitions of Care
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Jan 2023
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2022
CompletedFirst Posted
Study publicly available on registry
December 23, 2022
CompletedStudy Start
First participant enrolled
January 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedMay 23, 2025
April 1, 2025
2.5 years
November 17, 2022
May 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean glucose levels
Mean glucose levels based on home glucose meter and outpatient laboratory data post-discharge
30 days
Secondary Outcomes (15)
Number of hypoglycemic episodes
14, 30 and 90 days
Number of hyperglycemic episodes
14, 30 and 90 days
Healthcare utilization
14, 30 and 90 days
HbA1c
90 days
Time in hyperglycemia
14 days
- +10 more secondary outcomes
Study Arms (2)
DM Discharge Toolkit
EXPERIMENTALUp 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.
Current Standard of Care Discharge DM Training
NO INTERVENTIONUp 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- English speaking patients
- years of age and older
- Expected survival \>90 days
- Need for new insulin at time of hospital discharge
You may not qualify if:
- Patients with the inability to give informed consent
- Non-English speaking
- Not diagnosed with diabetes
- Not been newly prescribed insulin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amisha Wallia, MD
Northwestern University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 17, 2022
First Posted
December 23, 2022
Study Start
January 10, 2023
Primary Completion
July 1, 2025
Study Completion
September 1, 2025
Last Updated
May 23, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share