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My Diabetes Study - CGM Initiation Approach & Time In Range

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CGM initiation approach
Sponsored by
Holly Willis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring continuous glucose monitor, CGM, nutrition, diet, lifestyle, behavior change

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HealthPartners Institute dba International Diabetes CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nutrition-Focused Approach (NFA)

Self-Directed Approach (SDA)

Arm Description

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%).

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.

Outcomes

Primary Outcome Measures

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, daytime period (6AM to 11:59PM), and nighttime period (12AM to 5:59PM)

Secondary Outcome Measures

Total healthy eating index (HEI) score
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.

Full Information

First Posted
June 14, 2023
Last Updated
August 11, 2023
Sponsor
Holly Willis
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1. Study Identification

Unique Protocol Identification Number
NCT05928572
Brief Title
My Diabetes Study - CGM Initiation Approach & Time In Range
Official Title
Effect of CGM Initiation Approach on Time In Range in People With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Holly Willis

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose 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.
Detailed Description
Study Design: This is a non-pivotal, randomized, parallel group, two-arm, prospective study. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
continuous glucose monitor, CGM, nutrition, diet, lifestyle, behavior change

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutrition-Focused Approach (NFA)
Arm Type
Experimental
Arm Description
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%).
Arm Title
Self-Directed Approach (SDA)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CGM initiation approach
Intervention Description
Use of a nutrition-focused approach versus a self-directed approach during CGM initiation
Primary Outcome Measure Information:
Title
CGM-derived time in range (TIR)
Description
% 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)
Time Frame
From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
Secondary Outcome Measure Information:
Title
Total healthy eating index (HEI) score
Description
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.
Time Frame
Post-intervention period (day 40 to day 50)
Other Pre-specified Outcome Measures:
Title
CGM derived % time above >180 mg/dL
Description
% 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)
Time Frame
From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
Title
CGM-derived % time above >250 mg/dL
Description
% 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).
Time Frame
From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
Title
CGM-derived % time below <70 mg/dL
Description
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)
Time Frame
From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
Title
CGM-derived % time in tight range (% time with glucose 70-140 mg/dL)
Description
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).
Time Frame
From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
Title
% of participants reaching CGM-derived consensus targets
Description
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)
Time Frame
From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
Title
Total energy intake
Description
Energy intake will be calculated using 24 hour dietary recalls
Time Frame
From baseline (day -11) to post-intervention (day 40 to day 50)
Title
Macronutrient intake
Description
Macronutrient intake will be calculated using 24 hour dietary recalls
Time Frame
From baseline (day -11) to post-intervention (day 40 to day 50)
Title
Micronutrient intake
Description
Select micronutrient intake will be calculated using 24 hour dietary recalls
Time Frame
From baseline (day -11) to post-intervention (day 40 to day 50)
Title
Diabetes Distress Scale-17 score
Description
Diabetes distress will be measured using validated survey
Time Frame
From baseline (day -11) to post-intervention (day 50)
Title
HbA1c
Description
HbA1c will be evaluated using point of care assessment
Time Frame
From baseline (day -11) to post-intervention (day 50)
Title
Body weight
Description
Body weight based on calibrated study scale
Time Frame
From baseline (day -11) to post-intervention (day 50)
Title
Body mass index (BMI)
Description
kg/m2 will be used to calculate BMI
Time Frame
From baseline (day -11) to post-intervention (day 50)
Title
Fidelity to the intended intervention
Description
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
Time Frame
Post-intervention period (day 40 to day 50)
Title
Patient-reported behavioral change
Description
Survey of patient's perception of behavior change during the intervention to help describe mechanisms that may explain study results
Time Frame
Post-intervention period (day 40 to day 50)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Holly Willis, PhD, RDN
Phone
952-993-3219
Email
holly.willis@parknicollet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Willis, PhD
Organizational Affiliation
HealthPartners Institute, International Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners Institute dba International Diabetes Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Willis, PhD
Phone
952-993-3219
Email
holly.willis@parknicollet.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

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My Diabetes Study - CGM Initiation Approach & Time In Range

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