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| Name | Class |
|---|---|
| Academy of Nutrition and Dietetics | OTHER |
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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Holly Willis, PhD | HealthPartners Institute; International Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Institute dba International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
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.
Interviews were completed between September 2023 and March 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Semi-structured Inteviewees | People who participated in the semi-structured interviews |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Information about all of 15 people who participated in the interviews are provided.
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| ID | Title | Description |
|---|---|---|
| BG000 | Semi-structured Inteviews | People who participated in the semi-structured interviews |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | age in years was collected by assessing participants birthday at the time of the interview |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | People who met inclusion/exclusion criteria | Posted | Count of Participants | Participants | Immediately following the 2-month study completion visit in the My Diabetes study. |
|
This was a qualitative interview at one point in time. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
This was a qualitative interview. No adverse events were expected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Semi-structured Inteviewees | People who participated in the semi-structured interviews |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Holly Willis | HealthPartners Institute | 952-993-3219 | holly.willis@parknicollet.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 27, 2023 | Feb 4, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Immediately following the 2-month study completion visit in the My Diabetes study. |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Participants were asked to self-identify thier sex and this information was recorded on source documents | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Glycated Hemoglobin (HbA1c) | HbA1c was assessed during the parent UNITE study; this was done by collecting a small blood sample via a venous draw. The value was taken from the electronic medical record. | Mean | Standard Deviation | percent of glycated hemoglobin |
|
| Units | Counts |
|---|---|
| Participants |
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| 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. | People who met inclusion/exclusion criteria were included. | Posted | Count of Participants | Participants | Immediately following the 2-month study completion visit in the My Diabetes study. |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D004700 | Endocrine System Diseases |