N/A
N=15
Nutrition-Focused Approach During CGM Initiation: A Qualitative Study
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05988957 ↗Enrolled (actual)
15
Serious AEs
—
Results posted
May 2025
Primary outcome: Primary: Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study — 15; 15 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Semi-structured interviews using an IRB-approved interview guide (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HealthPartners Institute
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study |
15; 15 | — |
| SECONDARY Describe the Overall Experience of 15 Participants Receiving a Nutrition-focused Approach During CGM Initiation During the UNITE/MyDiabetes Study |
15; 15 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT05988957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.