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Diabetes Discharge Toolkit for Diabetes
N/A
Recruiting
Led By Amisha Wallia, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
English speaking patients
18 years of age and older
Must not have
Not been newly prescribed insulin
Patients with the inability to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14, 30 and 90 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new set of tools called the DM Discharge Toolkit to help patients who are new to using insulin manage their diabetes after leaving the hospital. The toolkit includes educational materials and practical resources to make it easier for these patients to take care of themselves at home.
Who is the study for?
This trial is for adults over 18 who have recently been prescribed insulin at hospital discharge, expected to live more than 90 days, and speak English. It's not suitable for those without a new insulin prescription, without a diabetes diagnosis, non-English speakers, or anyone unable to consent.
What is being tested?
The study is testing the 'DM Discharge Toolkit' designed to help patients manage their new insulin treatment after leaving the hospital. Participants are randomly chosen to receive this toolkit to see if it improves their care post-discharge.
What are the potential side effects?
Since this trial involves educational material rather than medication, there are no direct medical side effects. However, participants may experience stress or confusion if the information is overwhelming or unclear.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English.
Select...
I am 18 years old or older.
Select...
I need to start insulin when I leave the hospital.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not started taking insulin recently.
Select...
I am unable to understand and give consent for treatment.
Select...
I have not been diagnosed with diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14, 30 and 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14, 30 and 90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean glucose levels
Secondary study objectives
Diabetes Distress Scale
Diabetes Symptoms Questionnaire
Glycemic variability
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DM Discharge ToolkitExperimental Treatment1 Intervention
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 II: Current Standard of Care Discharge DM TrainingActive Control1 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The primary treatment for Type 1 Diabetes is insulin therapy, which involves the administration of exogenous insulin to manage blood glucose levels. Insulin works by facilitating the uptake of glucose into cells, thereby reducing blood glucose concentrations.
This is crucial for Type 1 Diabetes patients, whose bodies cannot produce insulin due to autoimmune destruction of pancreatic beta cells. Structured guidance and resources, such as those provided in the DM Discharge Toolkit, are essential for helping patients manage their insulin therapy effectively post-discharge.
These tools can improve adherence to treatment, optimize glycemic control, and reduce the risk of complications.
The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).An Evidence Map for Interventions Addressing Transition from Pediatric to Adult Care: A Systematic Review of Systematic Reviews.The role of theories in interventions targeting preteens with Type 1 diabetes: A critical literature review.
The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).An Evidence Map for Interventions Addressing Transition from Pediatric to Adult Care: A Systematic Review of Systematic Reviews.The role of theories in interventions targeting preteens with Type 1 diabetes: A critical literature review.
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,649 Previous Clinical Trials
958,651 Total Patients Enrolled
10 Trials studying Diabetes
3,116 Patients Enrolled for Diabetes
Amisha Wallia, MDPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not started taking insulin recently.I speak English.I am unable to understand and give consent for treatment.I am 18 years old or older.I have not been diagnosed with diabetes.I need to start insulin when I leave the hospital.You are expected to live for more than 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: DM Discharge Toolkit
- Group 2: Current Standard of Care Discharge DM Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.