What side effects are associated with this type of intervention?

The most common treatment for Type 1 Diabetes is insulin therapy, which can cause hypoglycemia, weight gain, and injection site reactions. Adjunctive therapies like metformin may lead to gastrointestinal issues such as nausea and diarrhea. Pramlintide, another adjunctive therapy, is associated with hypoglycemia, nausea, vomiting, and anorexia, particularly in the first month of use. GLP-1 receptor agonists can cause gastrointestinal symptoms like nausea and vomiting. Continuous subcutaneous insulin infusion (insulin pumps) and closed-loop systems may have technical issues and require careful management to avoid hypoglycemia.

What prior FDA approvals exist?

The FDA has approved several advanced technologies for the management of Type 1 Diabetes, including continuous glucose monitors (CGMs) and insulin pumps. CGMs, such as the Dexcom G6 and the FreeStyle Libre systems, provide real-time glucose readings and trends, helping patients manage their blood sugar levels more effectively. Insulin pumps, like the Medtronic MiniMed and the Tandem t:slim X2, deliver continuous subcutaneous insulin infusion, allowing for more precise insulin dosing. These technologies are integral to modern diabetes management and are similar to the tools being promoted in the T1D-CATCH trial to enhance diabetes care in young adults from underrepresented minority groups.

What other types of research exist?

Promising alternatives to the T1D-CATCH model for T1D patients include: 1) Hybrid closed-loop (HCL) systems, which have demonstrated improved glycemic control and patient satisfaction. 2) KNN-DSS, an FDA-accepted platform that improves glycemic outcomes and identifies dangerous insulin regimens early. 3) Open-source automated insulin delivery (AID) systems, which offer algorithm individualization and cost-effectiveness. 4) Telemedicine, which has shown modest reductions in A1C and improved diabetes management through remote monitoring and virtual care.

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T1D-CATCH Program for Type 1 Diabetes in Young Adults (T1DTechCHW Trial)

N/A

Recruiting

Led By Shivani Agarwal, MD, MPH

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

T1D duration ≥6 months

Age between 18-35 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 month mark

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program called T1D-CATCH where community health workers help young adults from minority groups with type 1 diabetes use diabetes technology better. The program includes education, goal-setting, peer support, and help with insurance paperwork. The aim is to see if this support improves their use of diabetes tools and overall care.

Who is the study for?

This trial is for young adults aged 18-30 with type 1 diabetes who are not currently using a connected diabetes technology system. Participants must be from underrepresented minority groups, specifically non-Hispanic Black or Hispanic, and speak English or Spanish. Those who are pregnant, have disabilities that interfere with participation, or have been in another related study recently cannot join.

What is being tested?

The T1D-CATCH program is being tested to see if it helps young adults from minority groups start and continue using diabetes technology over six months. The study will compare the effects of this enhanced community health worker model against usual care in a randomized controlled trial lasting nine months.

What are the potential side effects?

Since T1D-CATCH is a support program rather than a medication, traditional side effects aren't expected. However, participants may experience stress or discomfort when adopting new technologies or changes in their routine due to the intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had Type 1 Diabetes for at least 6 months.

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I am between 18 and 35 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 month mark

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 month mark

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 month mark for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Glycosylated hemoglobin A

Quality of Life (Diabetes Distress

Quality of Life (Diabetes Distress)

+3 more

Other study objectives

Adoption

Cost

Feasibility Check

+1 more

Awards & 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: T1D-CATCHExperimental Treatment1 Intervention

The CHW intervention will consist of both individual and optional group sessions with YA-URMs with T1D. In individual sessions, CHWs will provide T1D technology education, peer support, and social needs management. Over the 9-month study period, session frequency will involve weekly individual sessions based on participant technology milestones and an optional monthly CHW-led peer group support session. CHW individual and group sessions will be held via videoconferencing or in person, per participant preference and institutional COVID-19 rules.

Group II: Usual Care Control ConditionActive Control1 Intervention

Control arm participants will receive usual primary or endocrine care at Montefiore. Usual care consists of a physician or nurse practitioner visit with review of blood sugars and treatment decisions based on provider experience. Physicians in endocrinology practices are nested within a diabetes center with access to diabetes nurse practitioners/educators, dieticians, a psychologist, and nurses. In all practices, patients are recommended to see their physician or nurse practitioner every 3 months and attend individual or group sessions.

0 / 2Eligibility criteria met

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 most common treatments for Type 1 Diabetes (T1D) include insulin therapy and diabetes technology like continuous glucose monitors (CGMs) and insulin pumps. Insulin therapy involves administering insulin to regulate blood glucose levels, which is essential since T1D patients cannot produce insulin. Diabetes technology aids in real-time monitoring and precise insulin delivery, improving glucose control. The T1D-CATCH trial highlights the importance of these technologies, supported by community health workers, to enhance adherence and outcomes, particularly in young adults from underrepresented minority groups. This approach is vital as it can improve self-management, reduce complications, and enhance the quality of life for T1D patients.

A Systematic Review of Collective Evidences Investigating the Effect of Diabetes Monitoring Systems and Their Application in Health Care.Evaluation of Web-Based and In-Person Methods to Recruit Adults With Type 1 Diabetes for a Mobile Exercise Intervention: Prospective Observational Study.E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials.