Nutrition-Focused Approach During CGM Initiation: A Qualitative Study

Study Overview
=================
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.

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

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: Semi-structured interviews using an IRB-approved interview guide


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Semi-structured interviews using an IRB-approved interview guide|A single, semi-structured interview will be conducted using an IRB-approved interview guide. The interviews will be approximately 30 minutes total.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe CGM data use | 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 | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
continuous glucose monitor, CGM, nutrition, qualitative interview