Nutrition-Focused Approach During CGM Initiation: A Qualitative Study

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05988957
• Other study ID #: A22-279
• Status: Completed
• Start date: August 1, 2023
• Est. completion date: March 22, 2024

Study information

• Verified date: March 2024
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 22, 2024
• Est. primary completion date: March 22, 2024
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	HealthPartners Institute dba International Diabetes Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Academy of Nutrition and Dietetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.