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

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if access to a diabetes coach improves quality of life (QOL) for families of children with newly diagnosed type 1 diabetes. The main questions it aims to answer are: 1. Determine if there are beneficial effects on diabetes-related QOL at the end of the 6-month intervention. 2. Determine if potential beneficial effects persist beyond completion of the support intervention, as measured by diabetes-related QOL at 12 months and 24 months following diagnosis Participants assigned to the intervention group will have access to a diabetes coach for 6 months following type 1 diabetes diagnosis. They will be compared to participants who are assigned to the control group and are receiving usual care.

Will I have to stop taking my current medications?

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

How is the treatment Personalized Comprehensive Diabetes Support different from other treatments for type 1 diabetes?

Personalized Comprehensive Diabetes Support is unique because it combines health coaching with personalized self-management strategies, focusing on developing skills like goal-setting and problem-solving to empower patients to manage their diabetes effectively. Unlike traditional treatments, it emphasizes a person-centered approach tailored to individual needs and preferences, which can lead to more meaningful outcomes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Personalized Comprehensive Diabetes Support for type 1 diabetes?

Research shows that structured education programs for type 1 diabetes, like the DAFNE program, improve blood sugar control and reduce severe low blood sugar episodes. Coaching and follow-up support can help maintain these benefits by addressing barriers and supporting self-management skills. ^{1 6 7 8 9}

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

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]

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 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]

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]

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]

Citations

1. Brazil pubmed.ncbi.nlm.nih.gov

Type 1 diabetes mellitus: can coaching improve health outcomes? [2023]

2. England pubmed.ncbi.nlm.nih.gov

Follow-Up Support for Effective type 1 Diabetes self-management (The FUSED Model): A systematic review and meta-ethnography of the barriers, facilitators and recommendations for sustaining self-management skills after attending a structured education programme. [2021]

3. England 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. [2023]

4. United States 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Support, a self-guided online type 1 diabetes self-management education and support web application-a mixed methods study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Development and validation of the self-management Barriers and Supports Evaluation for working-aged adults with type 1 diabetes mellitus. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Understanding how different mechanism of life coaching offered to young adults with type 1 diabetes can improve their ability to see opportunities and overcome barriers. [2020]

8. United States 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. [2018]

9. Canada pubmed.ncbi.nlm.nih.gov

Health coaching in diabetes: empowering patients to self-manage. [2013]