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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

NIDDK T1D Trial 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.Check my eligibility

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.See study design

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.

NIDDK T1D Trial 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.

Select...

I am 18 years old or older.

Select...

I am 60 years old or older.

NIDDK T1D Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time in Range

Secondary outcome measures

Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes

Diabetes Distress for Adults with Type 1 Diabetes

Other outcome measures

Care Partner Burden

Diabetes Appraisal

Diabetes Self-Care Inventory Revised

+3 more

NIDDK T1D 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

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,100 Previous Clinical Trials

1,778,741 Total Patients Enrolled

Nancy A Allen, PhDPrincipal InvestigatorUniversity of Utah College of Nursing

Media Library

Share plus intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05937321 — N/A

Type 1 Diabetes Research Study Groups: Intervention Group- Virtual with Dyad Follow + Share plus, Control Group- Virtual with Dyad Follow + Diabetes Self-Management Education

Type 1 Diabetes Clinical Trial 2023: Share plus intervention Highlights & Side Effects. Trial Name: NCT05937321 — N/A

Share plus intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05937321 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrolment available in this experimentation for participants?

"Unfortunately, as indicated on clinicaltrials.gov this study is no longer actively recruiting; the posting was initially published on July 10th 2023 and last updated June 29th of the same year. However, 1265 alternative trials are presently seeking participants for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

National Institute of Diabetes and Digestive Kidney Diseases* Share Plus: Continuous Glucose Monitoring With Data Sharing in Older Adults With Type 1 Diabetes* and Their Care Partners to Improve Time in Range and Reduce Diabetes Distress.

Nancy Ann Allen 2023. "National Institute of Diabetes and Digestive Kidney Diseases* Share Plus: Continuous Glucose Monitoring With Data Sharing in Older Adults With Type 1 Diabetes* and Their Care Partners to Improve Time in Range and Reduce Diabetes Distress.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05937321.

All > Gestational Diabetes > Type 1 Diabetes