Nutrition-Focused Approach During CGM Initiation: A Qualitative Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-03-22

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No