Diabetes Coaching for Type 1 Diabetes

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Children over 16, Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a diabetes coach can improve the quality of life for families with children recently diagnosed with type 1 diabetes. The study will assess if a coach makes a difference immediately after diagnosis and whether those benefits persist over time. Families with children aged 16 or younger, who have a stable living situation, may qualify. Participants will either work with a coach for six months, receiving Personalized Comprehensive Diabetes Support, or continue with their usual care to determine which approach is more beneficial. As an unphased trial, this study offers families the opportunity to contribute to valuable research that could enhance diabetes care for newly diagnosed children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this diabetes coaching method is safe?

Research shows that personalized diabetes support, such as a diabetes coach, can safely aid in managing type 1 diabetes. Studies indicate that personalized plans, including insulin therapy and tools for monitoring blood sugar levels, receive positive feedback from patients. These methods improve diabetes control without major side effects. Personalized support aims to simplify and enhance diabetes management for families, ensuring the treatment remains safe and manageable for those involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the personalized comprehensive diabetes support because it offers tailored coaching right after a Type 1 diabetes diagnosis, which is not typically part of the current standard care. Unlike standard treatments that focus primarily on insulin therapy and glucose monitoring, this approach provides individualized guidance and support, potentially leading to better management and understanding of the condition from the start. By focusing on personalized support, researchers hope this method will improve patient outcomes and empower individuals to manage their diabetes more effectively.

What evidence suggests that personalized comprehensive diabetes support is effective for improving quality of life in families of children with type 1 diabetes?

Research shows that personalized support can help people with diabetes manage their condition more effectively. In this trial, participants in the intervention arm will receive personalized comprehensive diabetes support for six months after a type 1 diabetes diagnosis. Studies have found that treatments tailored to individual needs can improve blood sugar control, especially for those using insulin. These personalized approaches address medical needs and enhance quality of life by providing education and support. Early findings suggest that understanding personal habits and challenges leads to better self-care and diabetes management. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for families with children 16 or younger who've just been diagnosed with type 1 diabetes and have a stable living situation. It's not open to non-English speaking families or those with children older than 16.

Inclusion Criteria

My child, 16 or younger, has recently been diagnosed.

Stable living situation such that the same caregivers are anticipated to be caring for the child during the full 2-year study duration.

Exclusion Criteria

My child is older than 16 years.

Children whose families do not speak English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group receive personalized comprehensive diabetes support from a diabetes coach for 6 months following type 1 diabetes diagnosis

6 months

Follow-up

Participants are monitored for diabetes-related quality of life at 12 months and 24 months following diagnosis

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Comprehensive Diabetes Support

Trial Overview The study tests if having a diabetes coach for the first six months after diagnosis can improve life quality compared to usual care. Quality of life will be measured at the end, and again at 12 and 24 months post-diagnosis.

How Is the Trial Designed?

Group I: Intervention Active Control 1 Intervention

personalized comprehensive diabetes support for 6 months following type 1 diabetes diagnosis

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

In a 6-month study involving 100 adults with type 1 diabetes, the use of the iBGStar® glucose meter combined with an iPhone led to a significant reduction in A1c levels compared to traditional self-monitoring methods (-0.51 vs. -0.16, p = 0.04).

Both groups showed improvements in hypoglycemia fear scores, but the iBGStar® group did not experience an increased risk of hypoglycemia, indicating that this mobile technology can enhance glycemic control without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar&#174; in Type 1 Diabetes Management. Garg, SK., Shah, VN., Akturk, HK., et al.[2020]

Effective diabetes management requires patient adherence to treatment and lifestyle changes, which is often lacking; education combined with self-management support is beneficial.

Health coaching, focusing on self-efficacy and skills like goal-setting and problem-solving, has been shown to be highly effective in improving diabetes self-management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health coaching in diabetes: empowering patients to self-manage. Wong-Rieger, D., Rieger, FP.[2013]

The DAFNE programme significantly improves diabetes management outcomes, such as HbA1c levels and rates of severe hypoglycaemia, for up to 12 months after completion, highlighting its efficacy in educating individuals with Type 1 diabetes.

This study compares group follow-up versus traditional one-to-one visits for DAFNE graduates, aiming to determine the best method to maintain the benefits of the programme, with outcomes measured at 6, 12, and 18 months to ensure comprehensive evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Irish DAFNE study protocol: a cluster randomised trial of group versus individual follow-up after structured education for type 1 diabetes. Dinneen, SF., O' Hara, MC., Byrne, M., et al.[2023]

In a study of 81 youths with type 1 diabetes, using a glucometer-connected mobile app increased the frequency of self-monitoring blood glucose (SMBG) by 2.3 times with each additional data sync, indicating improved engagement in diabetes self-management.

However, the frequency of syncing glucometer data did not show a significant impact on hemoglobin A1c (HbA1c) levels or mean blood glucose, suggesting that while the app may enhance monitoring habits, its effect on overall glycemic control is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. Clements, MA., Staggs, VS.[2018]

A coaching intervention for 10 patients with type 1 diabetes led to a significant reduction in HbA1c levels from 8.0% to 7.78% after 3 months, indicating improved blood sugar control.

The frequency of self-monitoring of blood glucose (SMBG) also increased significantly, from a median of 16.5 tests per week at baseline to 29.0 tests at 3 months, suggesting enhanced self-management among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 1 diabetes mellitus: can coaching improve health outcomes? Magalhães, TPC., Fóscolo, RB., Soares, AN., et al.[2023]

Citations

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Advances in the Management of Diabetes Mellitus Personalized insulin therapy is of utmost importance in managing type 1 diabetes, as it allows for tailoring treatment to the individual's ...

2. diabetesjournals.org diabetesjournals.org/care/article/48/Supplement_1/S14/157553/1-Improving-Care-and-Promoting-Health-in

1. Improving Care and Promoting Health in Populations Gaps and disparities in diabetes management and outcomes are also prevalent among youth with diabetes in the U.S. Data from SEARCH for Diabetes ...

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Data-Driven Diabetes Education Guided by a Personalized ... The ability to quantify SMBs and understand patients' rationale may help improve diabetes self-care and related outcomes. This study describes our first steps ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.15476

What is meant by 'integrated personalized diabetes ... Integrated personalized diabetes management (IPDM) has emerged as a promising approach to improving outcomes in patients with diabetes mellitus (DM).

5. sciencedirect.com sciencedirect.com/science/article/pii/S0168822718311562

Integrated personalized diabetes management improves ... Integrated personalized diabetes management improves glycemic control in patients with insulin-treated type 2 diabetes: Results of the PDM-ProValue study ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06057662

Personalized Comprehensive Diabetes Support for ... A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A group or subgroup ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11983400/

Future horizons in diabetes: integrating AI and personalized ... Continuous Glucose Monitoring (CGM) and AI integration offer real-time data analytics and personalized treatment plans, enhancing glycemic control and reducing ...