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Behavioural Intervention

Continuous Glucose Monitoring for Type 1 Diabetes (NIDDK T1D Trial)

N/A

Recruiting

Led By Nancy A Allen, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

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

Must have

Type 1 Diabetes Diagnosis

≥18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change 12 weeks to 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an intervention to help people with diabetes and their care partners manage diabetes better, with the aim of improving time-in-range and reducing diabetes distress.

Who is the study for?

This trial is for older adults aged 60 and above with Type 1 Diabetes, who have an HbA1c level between 7.5% to 11%, use continuous glucose monitoring, and can manage their diabetes (possibly with help from a care partner). They must be new to the Follow app but willing to use it.

What is being tested?

The study tests the 'Share plus intervention', which focuses on sharing data between people with diabetes and their care partners using continuous glucose monitoring. The goal is to improve time spent in the ideal blood sugar range and reduce stress related to managing diabetes.

What are the potential side effects?

Since this trial involves data sharing through an app rather than medication or medical procedures, there are no direct physical side effects expected from participating in this study.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Type 1 Diabetes.

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I am 18 years old or older.

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I am 60 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change 12 weeks to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change 12 weeks to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change 12 weeks to 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Time in Range

Secondary study objectives

Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes

Diabetes Distress for Adults with Type 1 Diabetes

Other study objectives

Care Partner Burden

Diabetes Appraisal

Diabetes Self-Care Inventory Revised

+3 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: Intervention Group- Virtual with Dyad Follow + Share plusExperimental Treatment1 Intervention

The Share plus intervention is a behavioral intervention administered by a certified diabetes education and care specialist (CDCES) using telehealth. Share plus consists of three educational sessions to facilitate dyads' success in data sharing glucose levels. The Share plus intervention has five major components that are delivered using techniques of motivational interviewing: 1) shared appraisal, 2) communication strategies, 3) problem-solving strategies, 4) action planning and, 5) re-evaluating, practicing, and advancing.

Group II: Control Group- Virtual with Dyad Follow + Diabetes Self-Management EducationActive Control1 Intervention

Participants will receive diabetes self-management education using the Association of Diabetes Care and Education Specialists 7 education curriculum (ADCES7).

0 / 3Eligibility criteria met