Diabetes Toolkit at Discharge

NCT ID: NCT05663931

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2025-09-01

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2 Insulin Dependent Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

DM Discharge Toolkit

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Amisha Wallia

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amisha Wallia, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christina Coventry, MSN, RN

Role: CONTACT

312-908-5565

Facility Contacts

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Amisha Wallia, MD

Role: primary

312-503-2756

Other Identifiers

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STU00216291

Identifier Type: -

Identifier Source: org_study_id

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