SweetGoals App for Type 1 Diabetes

Overseen By Catherine Stanger, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Trustees of Dartmouth College

Must not be taking: Corticosteroids, Beta-blockers, Antipsychotics

Disqualifiers: Pregnancy, Severe illness, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a digital tool can help people with Type 1 diabetes better manage their blood sugar levels. Participants will use the SweetGoals app, which assists with self-monitoring and setting health goals. Some participants will also receive additional support, such as rewards for adhering to their plan or health coaching. Individuals who have had Type 1 diabetes for over 18 months and use specific blood sugar monitors are suitable candidates. As an unphased trial, participants can contribute to innovative research that may improve diabetes management tools.

Will I have to stop taking my current medications?

If you are taking medications that affect blood sugar control, like corticosteroids, beta-blockers, or certain antipsychotics, you would need to stop them to participate in this trial.

What prior data suggests that the SweetGoals app is safe for young adults with Type 1 diabetes?

Research has shown that the SweetGoals app, designed for young adults with Type 1 diabetes, helps track blood sugar levels and adhere to meal plans. Studies have primarily focused on the app's effectiveness in managing diabetes, rather than potential negative effects. As a digital tool, it is generally expected to be safe, with no reports of serious side effects.

The app is also undergoing tests with new features like rewards and coaching, aimed at boosting motivation and support. These additions appear harmless. Overall, the goal is to enhance diabetes management without introducing significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SweetGoals app for Type 1 Diabetes because it offers a fresh approach to managing the condition through digital tools. Unlike traditional treatments that primarily focus on insulin therapy and blood sugar monitoring, the SweetGoals app leverages technology to support lifestyle management. The app is tested in various configurations: on its own, with added incentives, with coaching, and a combination of all three. This multi-faceted approach not only aims to improve diabetes self-care through personalized guidance and motivation but also explores how different supportive elements can enhance user engagement and outcomes.

What evidence suggests that this trial's treatments could be effective for Type 1 diabetes?

Research has shown that digital health tools can help manage conditions like Type 1 diabetes. This trial tests the SweetGoals app to improve blood sugar levels by encouraging self-monitoring and personal goal-setting. Early findings suggest that apps like SweetGoals enhance self-management, potentially leading to better diabetes control. Participants may receive the SweetGoals app alone or with other interventions. Testing includes offering rewards for good habits, which might improve adherence to diabetes management plans. Additionally, some participants will receive coaching through motivational interviewing, which has improved results by providing personalized support and encouragement. Together, these elements might offer a comprehensive approach to help young adults manage their diabetes effectively. ^{1 2 3 4 6}

Who Is on the Research Team?

Catherine Stanger, Ph.D.

Principal Investigator

Trustees of Dartmouth College

Are You a Good Fit for This Trial?

This trial is for young adults with Type 1 diabetes who have had the condition for over 18 months and an A1c level of at least 7.5%. They must have seen their diabetes doctor in the last six months and use a glucose monitor compatible with Glooko. It's not for pregnant or breastfeeding individuals, those with severe illnesses like cystic fibrosis, severe cognitive issues, psychiatric conditions that affect participation, other types of diabetes, or if they're on certain meds that affect blood sugar.

Inclusion Criteria

I have been diagnosed with Type 1 Diabetes for over 18 months.

I have seen my doctor for type 1 diabetes management in the last 6 months.

I use a Glooko-compatible glucose monitoring device.

Exclusion Criteria

I have a history of blood disorders or have received blood transfusions.

You have a mental health condition that would make it difficult for you to take part in the study.

I am not taking medications that affect blood sugar levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Intervention

Participants receive the SweetGoals app intervention, with some receiving additional incentives or coaching

25 weeks

Weekly virtual interactions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Coaching
• Incentives
• SweetGoals app

Trial Overview The study tests a digital intervention called SweetGoals app aimed at improving blood sugar control in Type 1 diabetics. Everyone gets the core app features focused on self-monitoring and goal setting. Additionally, it will evaluate whether incentives for sticking to treatment plans and web-based health coaching can further improve outcomes.

How Is the Trial Designed?

Group I: App plus Incentives Experimental Treatment 2 Interventions

SweetGoals app + incentives=yes + coaching=no

Group II: App plus Coaching plus Incentives Experimental Treatment 3 Interventions

Sweetgoals app + incentives=yes + coaching=yes

Group III: App plus Coaching Experimental Treatment 2 Interventions

Sweetgoals app + incentives=no + coaching=yes

Group IV: App only Experimental Treatment 1 Intervention

Sweetgoals app only

Who Is Running the Clinical Trial?

Trustees of Dartmouth College

Lead Sponsor

Trials

32

Recruited

14,500+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04646473

NCT04646473 | Sweetgoals for Type 1 Diabetes The study will test an app and web-delivered intervention designed to improve glycemic control (HbA1c) among young adults with Type 1 diabetes.

2. c4tbh.org c4tbh.org/research-study/sweetgoals/

Thinking Outside the Clinic: A Digital Health Approach ... In the proposed study, we will provide an app (SweetGoals) to all participants as a “core” intervention. The app prompts participants to upload their diabetes ...

3. dhgeiselgiving.org dhgeiselgiving.org/sweetgoals-type1-diabetes-intervention

SweetGoals: Could Incentives and Coaching Help Young ... This app integrates with participants' diabetes device to set actionable weekly goals. During the six-month intervention, participants are also randomized to ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33620330/

A Digital Health Intervention (SweetGoals) for Young Adults ... A 2x2 factorial randomized trial will be conducted with 300 young adults ages 19-25 with type 1 diabetes and (Hb)A 1c ≥ 8.0%.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7943343/

A Digital Health Intervention (SweetGoals) for Young ... A 2x2 factorial randomized trial will be conducted with 300 young adults ages 19-25 with type 1 diabetes and (Hb)A 1c ≥ 8.0%.

6. apps.apple.com apps.apple.com/us/app/sweetgoals-for-t1d/id1533593553

SweetGoals for T1D on the App Store SweetGoals is a research study designed to help you meet recommendations for type 1 diabetes self-management. Using a digital coach, SweetGoals ...