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

159 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Holly Willis, PhD

Principal Investigator

HealthPartners Institute, International Diabetes Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+