My Diabetes Study - CGM Initiation Approach & Time In Range

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Holly Willis
Study ID
NCT05928572
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 25, 2023
Status verified
Mar 2026
Primary completion
Aug 16, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
159 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nutrition-Focused Approach (NFA)
    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%).
  • Active Comparator: Self-Directed Approach (SDA)
    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.

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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
HealthPartners Institute dba International Diabetes CenterMinneapolisMinnesota55416-

Find similar trials in Minneapolis, MN

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
HealthPartners Institute dba International Diabetes Center· Minneapolis, MN

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