Type 2 Diabetes
Conditions
Keywords
continuous glucose monitor, CGM, nutrition, qualitative interview
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.
Interventions
OTHERSemi-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.
Sponsors
Academy of Nutrition and Dietetics
HealthPartners Institute
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study | Immediately following the 2-month study completion visit in the My Diabetes 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 30 minute interviews with each participant were transcribed and thematic coding was used to describe how participants with T2D in the My Diabetes Study experienced the use of a nutrition-focused approach and its associated nutrition-focused CGM initiation materials 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. |
Countries
United States
Participant flow
Recruitment details
Interviews were completed between September 2023 and March 2024.
Pre-assignment details
All participants had to meet inclusion criteria for the larger UNITE study (NCT05928572), be randomly assigned to the nutrition-focused approach arm, complete all components of the 2-month UNITE study intervention, have adequate CGM data at the final postintervention assessment, and be willing to participate in a recorded interview.
Participants by arm
| Arm | Count |
|---|---|
| Semi-structured Inteviews People who participated in the semi-structured interviews | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Semi-structured Inteviews | — |
|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 7.4 | — |
| Glycated Hemoglobin (HbA1c) | 7.5 percent of glycated hemoglobin STANDARD_DEVIATION 0.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: Immediately following the 2-month study completion visit in the My Diabetes study.
Population: People who met inclusion/exclusion criteria
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semi-structured Inteviewees | Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study | Number of people completing interview | 15 Participants |
| Semi-structured Inteviewees | Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study | Number of participants who used CGM to make food-related decisions | 15 Participants |
Secondary
Describe the Overall Experience of 15 Participants Receiving a Nutrition-focused Approach During CGM Initiation During the UNITE/MyDiabetes Study
30 minute interviews with each participant were transcribed and thematic coding was used to describe how participants with T2D in the My Diabetes Study experienced the use of a nutrition-focused approach and its associated nutrition-focused CGM initiation materials 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.
Time frame: Immediately following the 2-month study completion visit in the My Diabetes study.
Population: People who met inclusion/exclusion criteria were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semi-structured Inteviewees | Describe the Overall Experience of 15 Participants Receiving a Nutrition-focused Approach During CGM Initiation During the UNITE/MyDiabetes Study | Number of Participants | 15 Participants |
| Semi-structured Inteviewees | Describe the Overall Experience of 15 Participants Receiving a Nutrition-focused Approach During CGM Initiation During the UNITE/MyDiabetes Study | Number who agreed pairing nutrition information with CGM initiation was helpful for diabetes care | 15 Participants |