Clinical trial NCT05988957: Nutrition-Focused Approach During CGM Initiation: A Qualitative Study
Official title: Perspectives on Using a Nutrition-focused Approach When Initiating Continuous Glucose Monitoring in People With Type 2 Diabetes: a Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: continuous glucose monitor
CGM
nutrition
qualitative interview
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Academy of Nutrition and Dietetics
First posted: 2023-08-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study
timeFrame: Immediately following the 2-month study completion visit in the My Diabetes study.
Secondary outcomes:
measure: Describe the Overall Experience of 15 Participants Receiving a Nutrition-focused Approach During CGM Initiation During the UNITE/MyDiabetes Study
timeFrame: Immediately following the 2-month study completion visit in the My Diabetes study.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: HealthPartners Institute dba International Diabetes Center
state: Minnesota
Study officials:
affiliation: HealthPartners Institute; International Diabetes Center
name: Holly Willis, PhD
role: PRINCIPAL_INVESTIGATOR
References: