Nutrition-Focused Approach During CGM Initiation: A Qualitative Study

March 29, 2024 updated by: Holly Willis, HealthPartners Institute

Perspectives on Using a Nutrition-focused Approach When Initiating Continuous Glucose Monitoring in People With Type 2 Diabetes: a Qualitative Study

The purpose of the qualitative research is to provide a deeper understanding of the perspectives of people with type 2 diabetes (T2D) who received a nutrition-focused approach (NFA) when initiating continuous glucose monitor (CGM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the qualitative research is to provide a deeper understanding of the perspectives of people with T2D who received the NFA when initiating CGM.

A single 30-minute semi-structured interview will be conducted in approximately 15 people who have completed participation in the A21-292 study (also called the My Diabetes Study).

The My Diabetes Study, is a randomized clinical trial to assess the impact of using a NFA or a self-directed approach during CGM initiation. The NFA was developed specifically for the randomized clinical trial study.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • HealthPartners Institute dba International Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adults who have met inclusion criteria for the My Diabetes study and who have completed the nutrition-focused approach arm of the study may be eligible.

Description

Inclusion Criteria:

  • Participant was randomized to the nutrition-focused approach arm of the My Diabetes study
  • Participant completed all required study visits in the My Diabetes study; this includes the baseline visit, the two intervention visits, and the study completion visit
  • Participant had at least 70% "Time CGM Active" on a 10-day Dexcom Clarity Report at study completion visit
  • Participant is willing to be recorded during the interview

Exclusion Criteria:

  • Participant was randomized to the self-directed approach study arm of the My Diabetes study
  • Participant is deemed unsuitable for participation due to any cause as determined by the Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe CGM data use
Time Frame: Immediately following the study completion visit in the My Diabetes study.
Transcribed audio recordings and inductive thematic coding will be used to describe how participants in the My Diabetes Study used CGM data when making food-related decisions after receiving a NFA during CGM initiation
Immediately following the study completion visit in the My Diabetes study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe overall experience of receiving a NFA during CGM initiation
Time Frame: Immediately following the study completion visit in the My Diabetes study.
Transcribed audio recordings and inductive thematic coding will be used to describe how participants with T2D in the My Diabetes Study experienced the use of a NFA and its associated nutrition-focused CGM initiation materials.
Immediately following the study completion visit in the My Diabetes study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

Academy of Nutrition and Dietetics

Investigators

  • Principal Investigator: Holly Willis, PhD, HealthPartners Institute; International Diabetes Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

March 22, 2024

Study Completion (Actual)

March 22, 2024

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A22-279

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Semi-structured interviews using an IRB-approved interview guide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe