Nutrition-Focused Approach During CGM Initiation: A Qualitative Study

Completed

Brief Summary: 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).

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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study	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 Outcome Measures

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