Nutrition-Focused Approach During CGM Initiation: A Qualitative Study

HealthPartners Institute

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: Semi-structured interviews using an IRB-approved interview guide

Study type: Observational

Funder types: Other

Identifiers

NCT05988957

A22-279

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design