Trial Outcomes & Findings for Nutrition-Focused Approach During CGM Initiation: A Qualitative Study (NCT NCT05988957)
NCT ID: NCT05988957
Last Updated: 2025-05-01
Results Overview
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.
COMPLETED
15 participants
Immediately following the 2-month study completion visit in the My Diabetes study.
2025-05-01
Participant Flow
Interviews were completed between September 2023 and March 2024.
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.
Participant milestones
| Measure |
Semi-structured Inteviewees
People who participated in the semi-structured interviews
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Semi-structured Inteviews
n=15 Participants
People who participated in the semi-structured interviews
|
|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 7.4 • n=15 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=15 Participants
|
|
Glycated Hemoglobin (HbA1c)
|
7.5 percent of glycated hemoglobin
STANDARD_DEVIATION 0.4 • n=15 Participants
|
PRIMARY outcome
Timeframe: Immediately following the 2-month study completion visit in the My Diabetes study.Population: People who met inclusion/exclusion criteria
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.
Outcome measures
| Measure |
Semi-structured Inteviewees
n=15 Participants
People who participated in the semi-structured interviews
|
|---|---|
|
Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study
Number of people completing interview
|
15 Participants
|
|
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 outcome
Timeframe: Immediately following the 2-month study completion visit in the My Diabetes study.Population: People who met inclusion/exclusion criteria were included.
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.
Outcome measures
| Measure |
Semi-structured Inteviewees
n=15 Participants
People who participated in the semi-structured interviews
|
|---|---|
|
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
|
|
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
|
Adverse Events
Semi-structured Inteviewees
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place