Diabetes Mellitus, Type 2NCT05663931
Diabetes Toolkit at Discharge
A study testing DM Discharge Toolkit in people with Diabetes Mellitus, Type 2 and Insulin Dependent Diabetes, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Dependent Diabetes
- What is being tested?
- DM Discharge Toolkit
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2024to 1 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking patients
- 18 years of age and older
- Expected survival >90 days
- Need for new insulin at time of hospital discharge
Who cannot join
- Patients with the inability to give informed consent
- Non-English speaking
- Not diagnosed with diabetes
- Not been newly prescribed insulin
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: 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.
Read the 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.
- Being tested
- DM Discharge Toolkit
- Keywords
- Insulin, Hospital discharge, Transitions of care
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM Discharge ToolkitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| DM Discharge Toolkit | Experimental | 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. Receives: Other: DM Discharge Toolkit |
| Current Standard of Care Discharge DM Training | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Mean glucose levels
Mean glucose levels based on home glucose meter and outpatient laboratory data post-discharge
Measured: 30 days
Secondary outcomes (15)
Number of hypoglycemic episodes
Number of glucoses < 70 mg/dl
Measured: 14, 30 and 90 days
Number of hyperglycemic episodes
Number of blood glucose levels >200 mg/dL
Measured: 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).
Measured: 14, 30 and 90 days
HbA1c
Hemoglobin A1c blood test
Measured: 90 days
Time in hyperglycemia
Time in hyperglycemia defined as > 200 mg/dl, outcome from continuous glucose monitor placement
Measured: 14 days
Time in hypoglycemia
Time in hyperglycemia defined as < 70 mg/dl, outcome from continuous glucose monitor placement
Measured: 14 days
Mean amplitude of glycemic excursion
MAGE, outcome from continuous glucose monitor placement
Measured: 14 days
Glycemic variability
A continuous glucose monitor will be used to monitor glucose levels from discharge to 14 days post discharge.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days, 30 days
Hospital Consumer Assessment of Healthcare Providers and Systems
Patient satisfaction survey
Measured: 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.
Measured: 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.
Measured: Baseline, 30 days, 90 days
Infection
Rate of infection (bacterial, viral, other)
Measured: 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start20 Aug 2024
- Primary completion1 May 2026
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amisha Wallia, Northwestern University
- Investigators
- Amisha Wallia, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663931
- Sponsor's protocol ID
- STU00216291
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No