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CGM Initiation Approach for Type 2 Diabetes

N/A

Waitlist Available

Led By Holly Willis, PhD

Research Sponsored by Holly Willis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

T2D diagnosis

Be older than 18 years old

Must not have

Intended use of > 4g acetaminophen/day or hydroxyurea during the study

Currently taking or planning to take any form of insulin, sulfonylureas, meglitinides, or other anti-hyperglycemic diabetes medication that carry a known hypoglycemia risk

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from post-intervention (day 40 to day 50) to follow-up (day 170 to day 180)

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at two approaches to introducing a CGM to people with type 2 diabetes to see if it affects how often their blood sugar is in an ideal range. #diabetes #CGM #T2D

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin irritation from the adhesive used to attach the CGM device or allergic reactions if sensitive to medical-grade adhesives or disinfectants like isopropyl alcohol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am taking or will take diabetes medication that can lower my blood sugar too much.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from post-intervention (day 40 to day 50) to follow-up (day 170 to day 180)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from post-intervention (day 40 to day 50) to follow-up (day 170 to day 180)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from post-intervention (day 40 to day 50) to follow-up (day 170 to day 180) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1 CGM-derived time in range (TIR)

Secondary study objectives

Total healthy eating index (HEI) score

Other study objectives

% of participants reaching CGM-derived consensus targets

Body mass index (BMI)

Body weight

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Nutrition-Focused Approach (NFA)Experimental Treatment1 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 Control1 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.

0 / 3Eligibility criteria met