Type 2 DiabetesNCT05928572
My Diabetes Study - CGM Initiation Approach & Time In Range
A study testing CGM initiation approach in people with Type 2 Diabetes, run by Holly Willis at 1 site in United States.
Trial summary
This study includes two phases. The purpose of Phase 1 of this study is to understand if there is a difference between two ways of introducing a continuous glucose monitor (CGM) to people with type 2 diabetes (T2D). 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?
- CGM initiation approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2023to 31 Dec 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >18 years of age
- T2D diagnosis
- HbA1c 7.0%-10.0% based on point-of-care test at screening
- Taking no diabetes medication or taking stable-dose diabetes medication(s) for at least 30 days; willing to maintain stable diabetes medication regimen for the duration of the study
- Has a personal cellular-plan or wifi-connected smartphone that is compatible with required CGM apps and which will be consistently available for duration of the study
- Has not used a personal CGM system within 90 days
Show all 10Show fewer
- Willing and able to wear CGM and use the associated CGM mobile apps throughout the duration of the study
- Willing and able to make diet/lifestyle modifications in response to CGM data
- Able to read and understand English
- Able to attend study visits and complete the requirements of study
Who cannot join
- Currently taking or planning to take any form of insulin, sulfonylureas, meglitinides, or other anti-hyperglycemic diabetes medication that carry a known hypoglycemia risk
- Has used a personal CGM in the 90 days prior to consent
- Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
- Skin conditions that are not compatible with CGM wear
- Intended use of > 4g acetaminophen/day or hydroxyurea during the study
- Planning to become pregnant; pregnant; or lactating
- Current participation in another interventional clinical trial
- Unsuitable for participation due to any other cause, including but not limited to significant comorbidities, as determined by Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Institute dba International Diabetes Center
Minneapolis, Minnesota, 55416
About this study
Official title: Effect of CGM Initiation Approach on Time In Range in People With Type 2 Diabetes
This study includes two phases. The purpose of Phase 1 of this study is to understand if there is a difference between two ways of introducing a continuous glucose monitor (CGM) to people with type 2 diabetes (T2D). The study will evaluate the effect of using a nutrition-focused approach (NFA) versus a self-directed approach (SDA) during CGM initiation on time in range (TIR) glucose. TIR is the percent of time that someone's glucose is between 70 and 180 mg/dL. It is possible that the approach used to introduce the CGM could impact TIR and other outcomes.
The purpose of Phase 2 of the study is to evaluate the impact of discontinuing CGM for 4 months after the completion of the Phase 1 study intervention on CGM-derived metrics, dietary intake assessment, and patient reported outcomes.
Read the detailed description
Study Design: This is a non-pivotal, randomized, parallel group, two-arm, prospective study. In Phase 1, this 60-day pilot study will evaluate the effect of a Nutrition-Focused Approach (NFA) versus a Self-Directed Approach (SDA) during CGM initiation in people with T2D. It is hypothesized that the NFA arm will see greater improvement in TIR than the SDA arm, due to the potential for dietary improvements that come from the NFA. To test this hypothesis, participants will be randomized 1:1 to either the NFA or the SDA arm. Participants in each arm complete baseline assessments, an in-person CGM initiation appointment, a remote follow-up appointment, and in-person post-intervention assessments. Difference in changes between baseline and post-intervention periods will be assessed.
Arms: In brief, the NFA arm participants will receive introduction to CGM with emphasis placed on using the CGM data to adjust food choices. The NFA will encourage food choices that align with evidence-based nutrition recommendations for people with diabetes (PWD), and that achieve internationally recognized glucose targets (e.g. glucose 70-180 mg/dL, and TIR > 70%). The SDA arm participants will receive introduction to CGM using manufacturer-provided manuals and resources. The SDA will encourage participants to use the device and apps in the way they feel is most useful to them. The SDA is intended to reflect current CGM initiation practices, which focus on technical use of the CGM and a general review of CGM data.
Intervention: Prior to the intervention, there is an approximately 10-day baseline assessment period, which includes blinded baseline CGM data assessment. The intervention begins on Day 0, which is the day the CGM sensor is paired with apps on the participant's personal cell phone. The intervention follows participants for approximately 50 days, which includes up to 10-days of post-intervention CGM data assessment (approximately Days 40 to 50). During the final 10 days, the participant is instructed to continue using the CGM device in accordance with the guidance provided based on randomization arm.
Sample Size: This study expects to enroll at least N=132 participants with the expectation for an analytic sample size of N=120. This sample size is based on the N needed to adequately power the primary hypothesis with a realistic and clinically meaningful effect size for % TIR.
Phase 2 will evaluate the impact of discontinuing CGM for 4 months after the completion of the Phase 1 study intervention for combined NFA and SDA arms. There is no intervention provided during Phase 2. The sample size is dependent the number of participants that complete Phase 1 and continue through the Phase 2 follow-up assessment period.
- Conditions
- Type 2 Diabetes
- Being tested
- CGM initiation approach
- Keywords
- continuous glucose monitor, CGM, nutrition, diet, lifestyle, behavior change
- 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.
CGM initiation approachOther
Use of a nutrition-focused approach versus a self-directed approach during CGM initiation
| Study group | Role | What they receive |
|---|---|---|
| Nutrition-Focused Approach (NFA) | Experimental | NFA arm participants will receive introduction to CGM from a diabetes care provider with emphasis placed on using the CGM data to adjust food choices. The NFA will encourage food choices that align with evidence-based nutrition recommendations for People with Diabetes (PWD), and that achieve internationally recognized glucose targets (e.g. glucose 70-180 mg/dL, and Time In Range > 70%). Receives: Other: CGM initiation approach |
| Self-Directed Approach (SDA) | Active comparator | The SDA arm participants will receive introduction to the CGM from a diabetes care provider using the CGM manufacturer-provided manuals and resources. The SDA will encourage participants to use the CGM device and apps in the way that feels most useful to them. The SDA is intended to reflect current CGM initiation practices, which focus on technical use of the CGM and a general review of CGM data. Receives: Other: CGM initiation approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Change in CGM-derived Time in Range (TIR)
% time with glucose 70-180 mg/dL is a core CGM metric; it will be assessed between groups and will be described as the 24-hour period
Measured: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
Secondary outcomes (1)
Total Healthy Eating Index (HEI) Score
The total Healthy Eating Index is a measure of diet quality, independent of quantity, used to assess alignment of food intake with the Dietary Guidelines for Americans. HEI will be calculated using standard methods. The scale ranges 0-100; a total score of 100 is possible. Higher scores indicate higher quality diets (better nutritional intake). Differences between groups during the post-intervention period will be described.
Measured: Post-intervention period (day 40 to day 50)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start25 Jul 2023
- Primary completion16 Aug 2024
- Study completion31 Dec 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holly Willis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Holly Willis, HealthPartners Institute
- Investigators
- Holly Willis, PhD, Principal investigator, HealthPartners Institute, International Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928572
- Sponsor's protocol ID
- A21-292
- Status last verified
- Mar 2026
- First submitted
- 14 Jun 2023
- Last updated
- 4 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: As allowable by the governing IRB and organizational legal requirements, select, de-identified datasets for the completed project will be made available. All datasets will be shared in compliance with human subject protection and Health Insurance Portability and Accountability Act (HIPAA) privacy regulations. Platform for sharing will be determined at study close.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CGM Initiation Approach on Time In Range in People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05928572
- Acronym / sponsor ID
- A21-292
- Conditions
- Type 2 Diabetes
- Keywords
- continuous glucose monitor, CGM, nutrition, diet, lifestyle, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Holly WillisUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Posted 4 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study includes two phases. The purpose of Phase 1 of this study is to understand if there is a difference between two ways of introducing a continuous glucose monitor (CGM) to people with type 2 diabetes (T2D). The study will evaluate the effect of using a nutrition-focused approach (NFA) versus a self-directed approach (SDA) during CGM initiation on time in range (TIR) glucose. TIR is the percent of time that someone's glucose is between 70 and 180 mg/dL. It is possible that the approach used to introduce the CGM could impact TIR and other outcomes.
The purpose of Phase 2 of the study is to evaluate the impact of discontinuing CGM for 4 months after the completion of the Phase 1 study intervention on CGM-derived metrics, dietary intake assessment, and patient reported outcomes.
Detailed description
Study Design: This is a non-pivotal, randomized, parallel group, two-arm, prospective study. In Phase 1, this 60-day pilot study will evaluate the effect of a Nutrition-Focused Approach (NFA) versus a Self-Directed Approach (SDA) during CGM initiation in people with T2D. It is hypothesized that the NFA arm will see greater improvement in TIR than the SDA arm, due to the potential for dietary improvements that come from the NFA. To test this hypothesis, participants will be randomized 1:1 to either the NFA or the SDA arm. Participants in each arm complete baseline assessments, an in-person CGM initiation appointment, a remote follow-up appointment, and in-person post-intervention assessments. Difference in changes between baseline and post-intervention periods will be assessed.
Arms: In brief, the NFA arm participants will receive introduction to CGM with emphasis placed on using the CGM data to adjust food choices. The NFA will encourage food choices that align with evidence-based nutrition recommendations for people with diabetes (PWD), and that achieve internationally recognized glucose targets (e.g. glucose 70-180 mg/dL, and TIR > 70%). The SDA arm participants will receive introduction to CGM using manufacturer-provided manuals and resources. The SDA will encourage participants to use the device and apps in the way they feel is most useful to them. The SDA is intended to reflect current CGM initiation practices, which focus on technical use of the CGM and a general review of CGM data.
Intervention: Prior to the intervention, there is an approximately 10-day baseline assessment period, which includes blinded baseline CGM data assessment. The intervention begins on Day 0, which is the day the CGM sensor is paired with apps on the participant's personal cell phone. The intervention follows participants for approximately 50 days, which includes up to 10-days of post-intervention CGM data assessment (approximately Days 40 to 50). During the final 10 days, the participant is instructed to continue using the CGM device in accordance with the guidance provided based on randomization arm.
Sample Size: This study expects to enroll at least N=132 participants with the expectation for an analytic sample size of N=120. This sample size is based on the N needed to adequately power the primary hypothesis with a realistic and clinically meaningful effect size for % TIR.
Phase 2 will evaluate the impact of discontinuing CGM for 4 months after the completion of the Phase 1 study intervention for combined NFA and SDA arms. There is no intervention provided during Phase 2. The sample size is dependent the number of participants that complete Phase 1 and continue through the Phase 2 follow-up assessment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition-Focused Approach (NFA) | Experimental | Other: CGM initiation approachNFA arm participants will receive introduction to CGM from a diabetes care provider with emphasis placed on using the CGM data to adjust food choices. The NFA will encourage food choices that align with evidence-based nutrition recommendations for People with Diabetes (PWD), and that achieve internationally recognized glucose targets (e.g. glucose 70-180 mg/dL, and Time In Range > 70%). |
| Self-Directed Approach (SDA) | Active comparator | Other: CGM initiation approachThe SDA arm participants will receive introduction to the CGM from a diabetes care provider using the CGM manufacturer-provided manuals and resources. The SDA will encourage participants to use the CGM device and apps in the way that feels most useful to them. The SDA is intended to reflect current CGM initiation practices, which focus on technical use of the CGM and a general review of CGM data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults >18 years of age
- T2D diagnosis
- HbA1c 7.0%-10.0% based on point-of-care test at screening
- Taking no diabetes medication or taking stable-dose diabetes medication(s) for at least 30 days; willing to maintain stable diabetes medication regimen for the duration of the study
- Has a personal cellular-plan or wifi-connected smartphone that is compatible with required CGM apps and which will be consistently available for duration of the study
Key exclusion criteria (8 listed)
- Currently taking or planning to take any form of insulin, sulfonylureas, meglitinides, or other anti-hyperglycemic diabetes medication that carry a known hypoglycemia risk
- Has used a personal CGM in the 90 days prior to consent
- Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
- Skin conditions that are not compatible with CGM wear
- Intended use of > 4g acetaminophen/day or hydroxyurea during the study
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 |
|---|---|---|
| CGM initiation approachUse of a nutrition-focused approach versus a self-directed approach during CGM initiation | Other | Nutrition-Focused Approach (NFA), Self-Directed Approach (SDA) |
Primary outcome
Phase 1 Change in CGM-derived Time in Range (TIR)
Time frame: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
% time with glucose 70-180 mg/dL is a core CGM metric; it will be assessed between groups and will be described as the 24-hour period
1 secondary outcome
Total Healthy Eating Index (HEI) Score
Time frame: Post-intervention period (day 40 to day 50)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. As allowable by the governing IRB and organizational legal requirements, select, de-identified datasets for the completed project will be made available. All datasets will be shared in compliance with human subject protection and Health Insurance Portability and Accountability Act (HIPAA) privacy regulations. Platform for sharing will be determined at study close.
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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?
A study testing CGM initiation approach in people with Type 2 Diabetes, run by Holly Willis 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 10 inclusion and 8 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 4 Mar 2026. 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 4 Mar 2026). 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?
Phase 1 Change in CGM-derived Time in Range (TIR) (time frame: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2026.