CGM Initiation Approach for Type 2 Diabetes

Overseen By Holly Willis, PhD, RDN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Holly Willis

Must not be taking: Insulin, Sulfonylureas, Meglitinides, others

Disqualifiers: Pregnancy, Skin conditions, Comorbidities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to help individuals with type 2 diabetes start using a continuous glucose monitor (CGM). One method uses CGM data to guide healthier food choices, while the other allows individuals to use the device in a way that suits them best. The study aims to determine which method more effectively maintains blood sugar levels within the target range. It is suitable for those with type 2 diabetes who have not used a CGM in the last 90 days and are open to adjusting their diet. As an unphased trial, this study offers a unique opportunity to explore personalized approaches to managing diabetes with CGM technology.

Will I have to stop taking my current medications?

You can continue taking your current diabetes medications as long as they have been stable for at least 30 days and you are willing to keep them stable during the study. However, if you are taking insulin or certain other diabetes medications that can cause low blood sugar, you cannot participate in this trial.

What prior data suggests that these CGM initiation approaches are safe for people with type 2 diabetes?

Research shows that continuous glucose monitors (CGMs) are generally safe for people with type 2 diabetes. Studies have found that using a CGM can help manage blood sugar more effectively and reduce health problems. For instance, some patients have experienced lower HbA1c levels, indicating better long-term blood sugar control.

In a large study, people with type 2 diabetes who began using a CGM had lower death rates, suggesting that CGMs might improve overall health. Another study found that CGM use led to fewer blood sugar issues, such as low blood sugar, compared to traditional fingerstick methods.

Overall, these findings suggest that CGMs are easy to use and offer significant health benefits without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different ways to use Continuous Glucose Monitors (CGM) for people with Type 2 Diabetes. Unlike traditional methods that focus on the technical use of CGMs, the Self-Directed Approach (SDA) allows participants to use CGM data in a way that feels most helpful to them, emphasizing personal comfort and choice. On the other hand, the Nutrition-Focused Approach (NFA) highlights using CGM data to make informed food choices, aiming to help participants meet specific glucose targets with nutrition tailored to diabetes management. By comparing these two approaches, researchers hope to uncover more effective ways to integrate CGMs into daily life, potentially improving glucose control and overall health for people with Type 2 Diabetes.

What evidence suggests that this trial's CGM initiation approaches could be effective for type 2 diabetes?

Research shows that starting continuous glucose monitoring (CGM) can greatly improve the management of type 2 diabetes. This trial will compare two different approaches to CGM initiation. The Self-Directed Approach (SDA) arm introduces participants to CGM using manufacturer-provided manuals and resources, encouraging them to use the device in a way that feels most useful to them. The Nutrition-Focused Approach (NFA) arm emphasizes using CGM data to adjust food choices according to evidence-based nutrition recommendations. Studies have found that using CGM can significantly lower HbA1c levels, a measure of long-term blood sugar control, and increase the time blood sugar stays within the healthy range of 70 to 180 mg/dL. For example, one study found that CGM use reduced HbA1c from 10.6% to 8.6%. Another study linked CGM with lower death rates in people with type 2 diabetes who use insulin. Overall, CGM helps people manage their diabetes better by providing real-time information that can guide daily decisions. ^{1 2 3 6 7}

Who Is on the Research Team?

Holly Willis, PhD

Principal Investigator

HealthPartners Institute, International Diabetes Center

Are You a Good Fit for This Trial?

Adults over 18 with type 2 diabetes who haven't used a personal CGM in the last 90 days. They must have a compatible smartphone, be willing to wear CGM, make diet changes based on its data, and attend study visits. Their HbA1c levels should be between 7.0%-10.0%. People using certain diabetes medications or with allergies to medical adhesives cannot participate.

Inclusion Criteria

I am not on diabetes medication or have been on a stable dose for at least 30 days and can keep it the same during the study.

I can attend all required study visits and follow the study's requirements.

Willing and able to wear CGM and use the associated CGM mobile apps throughout the duration of the study

Exclusion Criteria

I plan to use more than 4g of acetaminophen a day or take hydroxyurea during the study.

Unsuitable for participation due to any other cause, including but not limited to significant comorbidities, as determined by Investigator

Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline Assessment

Blinded baseline CGM data assessment over approximately 10 days

10 days

1 visit (in-person)

Phase 1 Treatment

Participants receive CGM initiation with either a Nutrition-Focused Approach (NFA) or a Self-Directed Approach (SDA) for 50 days

50 days

1 visit (in-person), 1 visit (remote)

Phase 2 Follow-up

Evaluation of the impact of discontinuing CGM for 4 months on CGM-derived metrics and patient-reported outcomes

4 months

Post-intervention Assessment

Participants undergo post-intervention assessments including CGM data evaluation and dietary intake assessment

10 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CGM initiation approach

Trial Overview The trial is testing two methods of starting continuous glucose monitoring (CGM) for people with type 2 diabetes: a nutrition-focused approach versus self-directed use. It looks at how these affect time in range (TIR), which measures blood sugar control, and other outcomes after stopping CGM use.

How Is the Trial Designed?

Group I: Nutrition-Focused Approach (NFA) Experimental Treatment 1 Intervention

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%).

Group II: Self-Directed Approach (SDA) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Holly Willis

Lead Sponsor

Trials

1

Recruited

160+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2840797

Duration of Continuous Glucose Monitoring and Glycemic ... The authors observed a clinically meaningful reduction in HbA1C following initiation of CGM. The greatest improvements were seen among ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40432529/

Initiation of Continuous Glucose Monitoring and Mortality in ... Conclusion: In a large national cohort, initiation of CGM was associated with lower mortality in T2D patients using insulin and indicates use of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S294996902500020X

Continuous glucose monitoring based glycemic control ... The primary outcome resulted in a statistically significant decrease in HbA1c (%) from 10.6 ± 1.7 at baseline to 8.6 ± 1.9 (P < 0.001) at the follow-up HbA1c ...

4. diabetesjournals.org diabetesjournals.org/clinical/article/43/1/139/157329/Continuous-Glucose-Monitoring-in-Individuals-With

Continuous Glucose Monitoring in Individuals With Type 2 ... The use of CGM in the population of people with type 2 diabetes has been shown to improve patients' ability to use real-time glycemic ...

5. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.24255

Initiating continuous glucose monitoring is associated with ... This study showed that CGM use in patients with diabetes was associated with clinically meaningful improvements in A1c and reduced health care resource ...

6. liebertpub.com liebertpub.com/doi/10.1089/dia.2025.0227

Initiation of Continuous Glucose Monitoring and Mortality in ... Initiation of continuous glucose monitoring is linked to improved glycemic control and fewer clinical events in Type 1 and Type 2 diabetes.

7. adces.org adces.org/education/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-101/effectiveness-of-cgms

CGM l Effectiveness of CGMs l danatech CGM is superior to self-monitoring of fingerstick glucose in reduction of HbA1c, hypoglycemia and other end points in people with type 1 diabetes.