Nutrition-Focused Approach During CGM Initiation: A Qualitative Study

NCT05988957 | Completed Results

• 1 other identifier: A22-279
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes

Keywords

continuous glucose monitor; CGM; nutrition; qualitative interview

Outcome Measures

Primary Outcomes (1)

• Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study

  30 minute interviews with each participant were transcribed and thematic coding was used to describe how participants in the My Diabetes Study used their CGM data when making food-related decisions after receiving a nutrition-focused approach during CGM initiation. Narrative summaries of the data were written up to describe the findings from all 15 participants. No objective outcome data is available to present in the outcome measure data table.

  Immediately following the 2-month study completion visit in the My Diabetes study.

Secondary Outcomes (1)

• Describe the Overall Experience of 15 Participants Receiving a Nutrition-focused Approach During CGM Initiation During the UNITE/MyDiabetes Study

  Immediately following the 2-month study completion visit in the My Diabetes study.

Interventions

Semi-structured interviews using an IRB-approved interview guide OTHER

A single, semi-structured interview will be conducted using an IRB-approved interview guide. The interviews will be approximately 30 minutes total.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead
• Academy of Nutrition and Dietetics: collaborator

Study Sites (1)

HealthPartners Institute dba International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

One limitation is that this research did not assess the perspectives and behaviors of people with T2D who initiated CGM without an Nutrition focused approach (eg, with a self-directed approach). Thus, it is unclear whether people without a Nutrition focused approach during CGM initiation would have similar experiences and report similar views during CGM initiation.

Results Point of Contact

• Title: Holly Willis
• Organization: HealthPartners Institute

holly.willis@parknicollet.com

952-993-3219

Study Officials

• Holly Willis, PhD

  HealthPartners Institute; International Diabetes Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RDN, CDCES

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: May 1, 2025
• Results First Posted: May 1, 2025

Record last verified: 2025-04

Locations

US (1)