Clinical trial NCT05928572: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: continuous glucose monitor
CGM
nutrition
diet
lifestyle
behavior change
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Phase 1 CGM-derived time in range (TIR)
timeFrame: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
Secondary outcomes:
measure: Total healthy eating index (HEI) score
timeFrame: Post-intervention period (day 40 to day 50)
Other outcomes:
measure: CGM derived % time above >180 mg/dL
timeFrame: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
measure: CGM-derived % time above >250 mg/dL
timeFrame: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
measure: CGM-derived % time below <70 mg/dL
timeFrame: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
measure: CGM-derived % time in tight range (% time with glucose 70-140 mg/dL)
timeFrame: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
measure: % of participants reaching CGM-derived consensus targets
timeFrame: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
measure: Total energy intake
timeFrame: From baseline (day -11) to post-intervention (day 40 to day 50)
measure: Macronutrient intake
timeFrame: From baseline (day -11) to post-intervention (day 40 to day 50)
measure: Micronutrient intake
timeFrame: From baseline (day -11) to post-intervention (day 40 to day 50)
measure: Diabetes Distress Scale-17 score
timeFrame: From baseline (day -11) to post-intervention (day 50)
measure: HbA1c
timeFrame: From baseline (day -11) to post-intervention (day 50)
measure: Body weight
timeFrame: From baseline (day -11) to post-intervention (day 50)
measure: Body mass index (BMI)
timeFrame: From baseline (day -11) to post-intervention (day 50)
measure: Fidelity to the intended intervention
timeFrame: Post-intervention period (day 40 to day 50)
measure: Patient-reported behavioral change
timeFrame: Post-intervention period (day 40 to day 50)
measure: Phase 2 CGM-derived time in range (TIR)
timeFrame: From post-intervention (day 40 to day 50) to follow-up (day 170 to day 180)
Locations:
city: Minneapolis
country: United States
facility: HealthPartners Institute dba International Diabetes Center
state: Minnesota
Study officials:
affiliation: HealthPartners Institute, International Diabetes Center
name: Holly Willis, PhD
role: PRINCIPAL_INVESTIGATOR
References: