15 Participants NeededMy employer runs this trial

Implementation Toolkits for Diabetes

JE
Overseen ByJulia EW Price, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Nemours Children's Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether special toolkits can help medical and psychology providers at Nemours Children's Hospital Delaware offer better support to families managing type 1 diabetes. The toolkits, which include the Base Implementation Toolkit (BIT), BIT-Enhanced, and BIT-Sustainment, provide strategies such as staff education and clear referral plans. The trial will assess the successful implementation of these toolkits in the hospital and evaluate their usefulness to the staff. Participants include professionals involved in the care or scheduling for adolescents with type 1 diabetes at the hospital. As an unphased trial, this study presents a unique opportunity to contribute to innovative strategies that could enhance patient care.

What prior data suggests that these implementation toolkits are safe for use by healthcare professionals?

Studies have shown that the Base Implementation Toolkit (BIT) used in diabetes care helps healthcare teams plan and maintain treatment changes. Reports of safety issues or side effects are absent, suggesting it is likely safe to use. Additionally, digital tools linked to these toolkits can improve health outcomes, such as better blood sugar control.

The BIT-Enhanced component also aims to improve diabetes care with supportive tools. While specific safety data isn't detailed, research indicates that digital tools can moderately improve diabetes management without major safety concerns.

For the BIT-Sustainment part, research highlights the benefits of ongoing support in managing diabetes, helping to maintain improvements over time. Again, no specific safety issues are reported, implying it is well-tolerated.

Overall, these toolkits focus on enhancing care and support for diabetes management. Current data does not indicate any safety concerns, suggesting a positive safety profile for these interventions.12345

Why are researchers excited about this trial?

Researchers are excited about the Implementation Toolkits for Diabetes because they offer a comprehensive approach to managing diabetes care. Unlike traditional treatments that focus primarily on medication and lifestyle changes, these toolkits provide a structured method to improve how diabetes care is delivered. The Base Implementation Toolkit (BIT) serves as the foundation, while BIT-Enhanced offers additional support if needed, and BIT-Sustainment ensures long-term success. This approach aims to streamline and enhance diabetes management, potentially leading to more consistent and effective outcomes for patients.

What evidence suggests that these implementation toolkits are effective for type 1 diabetes care?

Research has shown that the Base Implementation Toolkit (BIT), provided to participants in this trial, can help healthcare professionals deliver better care for people with diabetes. Studies have found that these toolkits improve diabetes outcomes by reducing stress and boosting resilience. The BIT-Enhanced approach, which includes digital tools and may be used if indicated in this trial, has helped manage blood sugar levels and improve communication between patients and healthcare providers. This results in better diabetes control, with small but positive effects on blood sugar levels, as evidenced by a reduction in HbA1c (a measure of blood sugar control) by 0.23 to 0.60 percentage points. Overall, these toolkits offer structured support that enhances diabetes care and management.678910

Are You a Good Fit for This Trial?

This trial is for healthcare professionals at Nemours Children's Hospital Delaware who work with children with type 1 diabetes, such as doctors, nurse practitioners, psychologists, and staff involved in scheduling or billing.

Inclusion Criteria

Involved in the direct clinical medical care of adolescents with T1D at Nemours Children's Hospital - Delaware
Involved in the direct clinical psychological care of adolescents with T1D at Nemours Children's Hospital - Delaware
Involved in the scheduling and/or insurance coverage verification in the clinical psychological care of adolescents with T1D at Nemours Children's Hospital - Delaware
See 1 more

Exclusion Criteria

Not involved in the direct clinical care or administrative parts of care of families with an adolescent with T1D at Nemours Children's Hospital - Delaware

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation

Participants attend educational and planning meetings, receive email updates, and complete surveys and interviews

4 weeks
2 visits (in-person), ongoing email updates

Active Implementation

Implementation of the Base Implementation Toolkit (BIT) and BIT-Enhanced strategies, including feedback loops and consultation support

6 months
Monthly meetings (in-person or virtual)

Sustainment

Training of Champions and independent leadership of meetings to ensure sustainability of Diabetes Coaching

4 months
Bi-monthly meetings (in-person or virtual)

Follow-up

Participants are monitored for the sustainability of adoption, reach, and fidelity of Diabetes Coaching

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Base Implementation Toolkit (BIT)
  • BIT-Enhanced
  • BIT-Sustainment

Trial Overview

The study is testing different toolkits designed to help medical teams deliver a diabetes coaching program. These toolkits include resources like training sessions and referral guides. The goal is to see if these tools are practical and helpful for providers.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Implementation ToolkitExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials
128
Recruited
18,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Effectiveness of Digital Diabetes Management Technology on ...

This technology simplifies blood glucose monitoring and boosts patient-provider communication [16]. Research indicates that it allows HCPs to assess data in ...

Health and Economic Benefits of Diabetes Interventions

Effective blood sugar management can reduce the risk of eye disease, kidney disease, and nerve disease by 40%. · Blood pressure management can ...

New Report Finds That Digital Diabetes Management ...

The studies show that these digital tools deliver small reductions in HbA1c of 0.23 to 0.60 percentage points compared to usual care.

Preliminary effectiveness and feasibility of ASHA-led ...

This study demonstrates that task-shifting and digital health tools can improve diabetes outcomes in low-resource settings.

A randomized controlled trial to test the effectiveness of two ...

In closing, our findings show that a technology-enhanced diabetes prevention program was effective in reducing BMI at 6 months and maintaining these results at ...

Improving Health Outcomes of People with Diabetes Mellitus

Diabetes prevention and control: combined diet and physical activity promotion programs to prevent type 2 diabetes among people at increased risk (abbreviated).

Diabetes Digital App Technology: Benefits, Challenges, and ...

They found only 14 apps with clinical outcomes data published. Medical devices are prone to security-breaching attacks; for example, incidents have been ...

Insulin: supporting safe administration in inpatient settings

This report considers the safe administration of insulin for people with known diabetes mellitus, who may be at risk of harm during ...

Overview of Data Outcomes in Diabetes Study

Focusing first on the 90-days data, we can see that mean glucose decreases in both people with type 1 diabetes and people with type 2 diabetes ...

UVA Health

In a 16-week clinical trial, participants who used the algorithm saw their average time in a safe blood-sugar range jump from 54.1 to 75.3 ...