Nutrition-Focused Approach During CGM Initiation: A Qualitative Study

An observational study of Type 2 Diabetes, run by HealthPartners Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Semi-structured interviews using an IRB-approved interview guide
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2023to 22 Mar 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

HealthPartners Institute dba International Diabetes Center
Minneapolis, Minnesota, 55416

Other trials in United States

About this study

Official title: Perspectives on Using a Nutrition-focused Approach When Initiating Continuous Glucose Monitoring in People With Type 2 Diabetes: a Qualitative Study

Read the 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.

Conditions: Type 2 Diabetes
Being tested: Semi-structured interviews using an IRB-approved interview guide
Keywords: continuous glucose monitor, CGM, nutrition, qualitative interview
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202322 Mar 2024

First posted14 Aug 2023
Study start1 Aug 2023
Primary completion22 Mar 2024
Study completion22 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05988957
Sponsor's protocol ID: A22-279
Status last verified: Apr 2025
First submitted: 3 Aug 2023
Last updated: 1 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Perspectives on Using a Nutrition-focused Approach When Initiating Continuous Glucose Monitoring in People With Type 2 Diabetes: a Qualitative Study
ClinicalTrials.gov ID: NCT05988957
Acronym / sponsor ID: A22-279
Conditions: Type 2 Diabetes
Keywords: continuous glucose monitor, CGM, nutrition, qualitative interview
Study type: Observational
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: HealthPartners InstituteUniversity, hospital or other
Collaborators: Academy of Nutrition and Dietetics
Study start: 1 Aug 2023 (actual)
Primary completion: 22 Mar 2024 (actual)
Study completion: 22 Mar 2024 (actual)
First posted: 14 Aug 2023 (actual)
Results: Posted 1 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Semi-structured interviews using an IRB-approved interview guideA single, semi-structured interview will be conducted using an IRB-approved interview guide. The interviews will be approximately 30 minutes total.	Other	–

Primary outcome

Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study
Time frame: 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.

1 secondary outcome

Describe the Overall Experience of 15 Participants Receiving a Nutrition-focused Approach During CGM Initiation During the UNITE/MyDiabetes Study
Time frame: Immediately following the 2-month study completion visit in the My Diabetes study.

Results and safety

Results posted to the registry on 1 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Semi-structured Inteviewees	15	15

Primary outcome: Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study

Time frame: Immediately following the 2-month study completion visit in the My Diabetes study.. Count of participants. Unit: Participants

Measure	Semi-structured Inteviewees n = 15
Number of people completing interview	15
Number of participants who used CGM to make food-related decisions	15

Population analysed: People who met inclusion/exclusion criteria

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Semi-structured Inteviewees	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Holly Willis, PhD principal investigator

HealthPartners Institute; International Diabetes Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by HealthPartners Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study (time frame: Immediately following the 2-month study completion visit in the My Diabetes study.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05988957.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.