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Completed

NCT Number: NCT05988957

Nutrition-Focused Approach During CGM Initiation: 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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HealthPartners Institute dba International Diabetes Center

Minneapolis, Minnesota, 55416, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semi-structured interviews using an IRB-approved interview guide

Other

A single, semi-structured interview will be conducted using an IRB-approved interview guide. The interviews will be approximately 30 minutes total.

Primary outcomes

  1. Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study

    Time frame: Immediately following the 2-month study completion visit in the My Diabetes study.

    30 minute interviews with each participant were transcribed and thematic coding was used to describe how participants in the My Diabetes Study used their CGM data when making food-related decisions after receiving a nutrition-focused approach during CGM initiation. Narrative summaries of the data were written up to describe the findings from all 15 participants. No objective outcome data is available to present in the outcome measure data table.

Secondary outcomes

  1. Describe the Overall Experience of 15 Participants Receiving a Nutrition-focused Approach During CGM Initiation During the UNITE/MyDiabetes Study

    Time frame: Immediately following the 2-month study completion visit in the My Diabetes study.

    30 minute interviews with each participant were transcribed and thematic coding was used to describe how participants with T2D in the My Diabetes Study experienced the use of a nutrition-focused approach and its associated nutrition-focused CGM initiation materials during CGM initiation. Narrative summaries of the data were written up to describe the findings from all 15 participants. No objective outcome data is available to present in the outcome measure data table.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Academy of Nutrition and Dietetics

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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