My Diabetes Study - CGM Initiation Approach & Time In Range

NCT05928572 | Completed Results FDA Device

• 1 other identifier: A21-292
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Type 2 Diabetes

Keywords

continuous glucose monitor; CGM; nutrition; diet; lifestyle; behavior change

Outcome Measures

Primary Outcomes (1)

• 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

  From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)

Secondary Outcomes (1)

• Total Healthy Eating Index (HEI) Score

  Post-intervention period (day 40 to day 50)

Other Outcomes (14)

• Change in CGM Derived % Time Above >180 mg/dL

  From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)

• Change in CGM-derived % Time Above >250 mg/dL

  From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)

• Change in CGM-derived % Time Below <70 mg/dL

  From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)

Study Arms (2)

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%).

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.

Other: CGM initiation approach

Interventions

CGM initiation approach OTHER

Use of a nutrition-focused approach versus a self-directed approach during CGM initiation

Nutrition-Focused Approach (NFA); Self-Directed Approach (SDA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Holly Willis: lead

Study Sites (1)

HealthPartners Institute dba International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Holly Willis
• Organization: HealthPartners Institute, International Diabetes Center

holly.willis@parknicollet.com

952-993-3219

Study Officials

• Holly Willis, PhD

  HealthPartners Institute, International Diabetes Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 3, 2023
• Study Start: July 25, 2023
• Primary Completion: August 16, 2024
• Study Completion: December 31, 2024
• Last Updated: March 4, 2026
• Results First Posted: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)