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Completed

NCT Number: NCT05928572

My Diabetes Study - CGM Initiation Approach & Time In Range

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Institute dba International Diabetes Center

Minneapolis, Minnesota, 55416, United States

About this study

Study Design: This is a non-pivotal, randomized, parallel group, two-arm, prospective study. In Phase 1, this 60-day pilot study will evaluate the effect of a Nutrition-Focused Approach (NFA) versus a Self-Directed Approach (SDA) during CGM initiation in people with T2D. It is hypothesized that the NFA arm will see greater improvement in TIR than the SDA arm, due to the potential for dietary improvements that come from the NFA. To test this hypothesis, participants will be randomized 1:1 to either the NFA or the SDA arm. Participants in each arm complete baseline assessments, an in-person CGM initiation appointment, a remote follow-up appointment, and in-person post-intervention assessments. Difference in changes between baseline and post-intervention periods will be assessed.

Arms: In brief, the NFA arm participants will receive introduction to CGM 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 TIR > 70%). The SDA arm participants will receive introduction to CGM using manufacturer-provided manuals and resources. The SDA will encourage participants to use the device and apps in the way they feel is 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.

Intervention: Prior to the intervention, there is an approximately 10-day baseline assessment period, which includes blinded baseline CGM data assessment. The intervention begins on Day 0, which is the day the CGM sensor is paired with apps on the participant's personal cell phone. The intervention follows participants for approximately 50 days, which includes up to 10-days of post-intervention CGM data assessment (approximately Days 40 to 50). During the final 10 days, the participant is instructed to continue using the CGM device in accordance with the guidance provided based on randomization arm.

Sample Size: This study expects to enroll at least N=132 participants with the expectation for an analytic sample size of N=120. This sample size is based on the N needed to adequately power the primary hypothesis with a realistic and clinically meaningful effect size for % TIR.

Phase 2 will evaluate the impact of discontinuing CGM for 4 months after the completion of the Phase 1 study intervention for combined NFA and SDA arms. There is no intervention provided during Phase 2. The sample size is dependent the number of participants that complete Phase 1 and continue through the Phase 2 follow-up assessment period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CGM initiation approach

Other

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

Primary outcomes

  1. 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)

    % 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

Secondary outcomes

  1. Total Healthy Eating Index (HEI) Score

    Time frame: Post-intervention period (day 40 to day 50)

    The total Healthy Eating Index is a measure of diet quality, independent of quantity, used to assess alignment of food intake with the Dietary Guidelines for Americans. HEI will be calculated using standard methods. The scale ranges 0-100; a total score of 100 is possible. Higher scores indicate higher quality diets (better nutritional intake). Differences between groups during the post-intervention period will be described.

Other outcomes

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

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

    % time above >180 mg/dL is considered a core CGM metric; time above range. This will be described as the 24-hour period

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

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

    % time above >250 mg/dL is considered a core CGM metric; time above range. This will be described as the 24-hour period

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

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

    CGM-derived % time <70 mg/dL is considered a core CGM metric; time below range This will be described as the 24-hour period

  4. Change in CGM-derived % Time in Tight Range (% Time With Glucose 70-140 mg/dL)

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

    Time in tight range is considered another CGM metric. This will be described as the 24-hour period

  5. Odds Ratio for Participants Reaching CGM-derived Consensus Targets by Arm

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

    Describes the odds ratio for participants who reach consensus target or >70% TIR (% time with glucose 70-180 mg/dL)

  6. Change in Total Energy Intake

    Time frame: From baseline (day -11) to post-intervention (day 40 to day 50)

    Energy intake will be calculated using 24 hour dietary recalls

  7. Change in Carbohydrate Intake

    Time frame: From baseline (day -11) to post-intervention (day 40 to day 50)

    Carbohydrate intake will be calculated using 24 hour dietary recalls

  8. Change in Calcium Intake

    Time frame: From baseline (day -11) to post-intervention (day 40 to day 50)

    Select micronutrient (calcium) intake will be calculated using 24 hour dietary recalls

  9. Change in Total Diabetes Distress Scale-17 Score

    Time frame: From baseline (day -11) to post-intervention (day 50)

    Diabetes distress will be measured using the Diabetes Distress Scale-17 score as indicated by validated survey. The total DDS-17 scale allows for a range of scores from 1 to 6, with a minimum of 1 and a maximum total of 6. A lower score means less distress and is better. Scores less than 2 generally mean little to no distress. A minimal clinically important difference is considered and improvement or worsening of more than 0.25.

  10. Change in HbA1c

    Time frame: From baseline (day -11) to post-intervention (day 50)

    HbA1c will be evaluated using point of care assessment

  11. Change in Body Weight

    Time frame: From baseline (day -11) to post-intervention (day 50)

    Body weight based on calibrated study scale

  12. Change in Body Mass Index (BMI)

    Time frame: From baseline (day -11) to post-intervention (day 50)

    kg/m^2 will be used to calculate BMI

  13. Fidelity to the Intended Intervention

    Time frame: Post-intervention period (day 40 to day 50)

    Survey of care providers: what percent of content -- the intended intervention components -- were delivered

  14. Change in Phase 2 CGM-derived Time in Range (TIR)

    Time frame: From post-intervention (day 40 to day 50) to follow-up (day 170 to day 180)

    % time with glucose 70-180 mg/dL from post-intervention to 4-month follow-up

Sponsors and collaborators

Lead sponsor

Holly Willis

Other

Registry information

Official study title

Effect of CGM Initiation Approach on Time In Range in People With Type 2 Diabetes

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2023
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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