My Diabetes Study - CGM Initiation Approach & Time In Range

October 24, 2023 updated by: Holly Willis

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Recruiting
        • HealthPartners Institute dba International Diabetes Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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%).
Other: CGM initiation approach
Use of a nutrition-focused approach versus a self-directed approach during CGM initiation
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.
Other: CGM initiation approach
Use of a nutrition-focused approach versus a self-directed approach during CGM initiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 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, daytime period (6AM to 11:59PM), and nighttime period (12AM to 5:59PM)
From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. 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.
Post-intervention period (day 40 to day 50)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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, daytime period (6AM to 11:59PM), and nighttime period (12AM to 5:59PM)
From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
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, daytime period (6AM to 11:59PM), and nighttime period (12AM to 5:59PM).
From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
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, daytime period (6AM to 11:59PM), and nighttime period (12AM to 5:59PM)
From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
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, daytime period (6AM to 11:59PM), and nighttime period (12AM to 5:59PM).
From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
% of participants reaching CGM-derived consensus targets
Time Frame: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
Consensus targets include the % of participants who reach >70% TIR (% time with glucose 70-180 mg/dL) and the % who reach ≥5% improvement in TIR (% time with glucose 70-180 mg/dL)
From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
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
From baseline (day -11) to post-intervention (day 40 to day 50)
Macronutrient intake
Time Frame: From baseline (day -11) to post-intervention (day 40 to day 50)
Macronutrient intake will be calculated using 24 hour dietary recalls
From baseline (day -11) to post-intervention (day 40 to day 50)
Micronutrient intake
Time Frame: From baseline (day -11) to post-intervention (day 40 to day 50)
Select micronutrient intake will be calculated using 24 hour dietary recalls
From baseline (day -11) to post-intervention (day 40 to day 50)
Diabetes Distress Scale-17 score
Time Frame: From baseline (day -11) to post-intervention (day 50)
Diabetes distress will be measured using validated survey
From baseline (day -11) to post-intervention (day 50)
HbA1c
Time Frame: From baseline (day -11) to post-intervention (day 50)
HbA1c will be evaluated using point of care assessment
From baseline (day -11) to post-intervention (day 50)
Body weight
Time Frame: From baseline (day -11) to post-intervention (day 50)
Body weight based on calibrated study scale
From baseline (day -11) to post-intervention (day 50)
Body mass index (BMI)
Time Frame: From baseline (day -11) to post-intervention (day 50)
kg/m2 will be used to calculate BMI
From baseline (day -11) to post-intervention (day 50)
Fidelity to the intended intervention
Time Frame: Post-intervention period (day 40 to day 50)
Survey of care providers and participants will assess: dose (minutes of intervention), content (were intended intervention components delivered), perception of content enactment and satisfaction with intervention
Post-intervention period (day 40 to day 50)
Patient-reported behavioral change
Time Frame: Post-intervention period (day 40 to day 50)
Survey of patient's perception of behavior change during the intervention to help describe mechanisms that may explain study results
Post-intervention period (day 40 to day 50)
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 for combined NFA and SDA arms.
From post-intervention (day 40 to day 50) to follow-up (day 170 to day 180)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holly Willis

Investigators

  • Principal Investigator: Holly Willis, PhD, HealthPartners Institute, International Diabetes Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A21-292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As allowable by the governing IRB and organizational legal requirements, select, de-identified datasets for the completed project will be made available. All datasets will be shared in compliance with human subject protection and Health Insurance Portability and Accountability Act (HIPAA) privacy regulations. Platform for sharing will be determined at study close.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on CGM initiation approach

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe