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Active, Not Recruiting

NCT Number: NCT05663931

Diabetes Toolkit at Discharge

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Mellitus, Type 2 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Dependent Diabetes Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DM Discharge Toolkit

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.

Primary outcomes

  1. Mean glucose levels

    Time frame: 30 days

    Mean glucose levels based on home glucose meter and outpatient laboratory data post-discharge

Secondary outcomes

  1. Number of hypoglycemic episodes

    Time frame: 14, 30 and 90 days

    Number of glucoses < 70 mg/dl

  2. Number of hyperglycemic episodes

    Time frame: 14, 30 and 90 days

    Number of blood glucose levels >200 mg/dL

  3. Healthcare utilization

    Time frame: 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).

  4. HbA1c

    Time frame: 90 days

    Hemoglobin A1c blood test

  5. Time in hyperglycemia

    Time frame: 14 days

    Time in hyperglycemia defined as > 200 mg/dl, outcome from continuous glucose monitor placement

  6. Time in hypoglycemia

    Time frame: 14 days

    Time in hyperglycemia defined as < 70 mg/dl, outcome from continuous glucose monitor placement

  7. Mean amplitude of glycemic excursion

    Time frame: 14 days

    MAGE, outcome from continuous glucose monitor placement

  8. Glycemic variability

    Time frame: 14 days

    A continuous glucose monitor will be used to monitor glucose levels from discharge to 14 days post discharge.

  9. Diabetes Symptoms Questionnaire

    Time frame: 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.

  10. Summary of Diabetes Self Care Activities

    Time frame: 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.

  11. Diabetes Distress Scale

    Time frame: 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.

  12. Hospital Consumer Assessment of Healthcare Providers and Systems

    Time frame: 14 days, 30 days

    Patient satisfaction survey

  13. Partner Diabetes Distress Scale

    Time frame: 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.

  14. Perceived Stress Scale

    Time frame: 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.

  15. Infection

    Time frame: 30 and 90 days

    Rate of infection (bacterial, viral, other)

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2022
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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