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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition-Focused Approach (NFA) | Experimental | 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%). |
|
| Self-Directed Approach (SDA) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM initiation approach | Other | Use of a nutrition-focused approach versus a self-directed approach during CGM initiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 Change in 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 | From baseline (day -11 to day 0) to post-intervention (day 40 to day 50) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CGM Derived % Time Above >180 mg/dL | % time above >180 mg/dL is considered a core CGM metric; time above range. This will be described as the 24-hour period | From baseline (day -11 to day 0) to post-intervention (day 40 to day 50) |
| Change in CGM-derived % Time Above >250 mg/dL |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly Willis, PhD | HealthPartners Institute, International Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Institute dba International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
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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Once enrolled, participants begin baseline screening assessments. Participants had to meet glycated hemoglobin requirements and provide a minimum of 7 days of blinded CGM data in order to proceed with randomization and intervention participation. In some cases participants who consented/enrolled were not eligible to continue to randomization due to post-enrollment inclusion criteria. This is why more participants were enrolled than were assigned to each arm (N=159 versus N=132).
The trial was conducted by the International Diabetes Center (IDC) in an urban clinic setting (Minneapolis, MN). The first participant was enrolled and consented on July 25, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nutrition Focused Approach (NFA) | NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations. |
| FG001 | Self Directed Approach (SDA) | The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
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| Phase 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nutrition Focused Approach (NFA) | NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1 Change in 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 | Posted | Mean | 95% Confidence Interval | % of time in 24 hours | From baseline (day -11 to day 0) to post-intervention (day 40 to day 50) |
|
Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).
AEs were only reported if they were considered a Reportable AEs per protocol. Reportable AEs included (1) CGM sensor-related reactions or infections requiring treatment by a medical provider and/or prescription medication, (2) severe hypoglycemia defined as requiring assistance of another person, and (3) severe hyperglycemia if the event involved diabetic ketoacidosis or hyperosmolar hyperglycemic state as defined by Kitabchi et al. SAEs followed ClinicalTrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 2 - Nutrition Focused Approach (NFA) | Phase 2 for NFA was an observational follow-up period only. Participants ended the NFA intervention and did not receive any study-related care during the follow-up period. They returned to the clinic at the end of follow-up for assessments only. NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Holly Willis | HealthPartners Institute, International Diabetes Center | 952-993-3219 | holly.willis@parknicollet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2024 | Sep 26, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Post-intervention period (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 |
| From baseline (day -11 to day 0) to post-intervention (day 40 to day 50) |
| Change in CGM-derived % Time Below <70 mg/dL | CGM-derived % time <70 mg/dL is considered a core CGM metric; time below range This will be described as the 24-hour period | From baseline (day -11 to day 0) to post-intervention (day 40 to day 50) |
| Change in CGM-derived % Time in Tight Range (% Time With Glucose 70-140 mg/dL) | Time in tight range is considered another CGM metric. This will be described as the 24-hour period | From baseline (day -11 to day 0) to post-intervention (day 40 to day 50) |
| Odds Ratio for Participants Reaching CGM-derived Consensus Targets by Arm | Describes the odds ratio for participants who reach consensus target or >70% TIR (% time with glucose 70-180 mg/dL) | From baseline (day -11 to day 0) to post-intervention (day 40 to day 50) |
| Change in Total Energy Intake | Energy intake will be calculated using 24 hour dietary recalls | From baseline (day -11) to post-intervention (day 40 to day 50) |
| Change in Carbohydrate Intake | Carbohydrate intake will be calculated using 24 hour dietary recalls | From baseline (day -11) to post-intervention (day 40 to day 50) |
| Change in Calcium Intake | Select micronutrient (calcium) intake will be calculated using 24 hour dietary recalls | From baseline (day -11) to post-intervention (day 40 to day 50) |
| Change in Total Diabetes Distress Scale-17 Score | 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. | From baseline (day -11) to post-intervention (day 50) |
| Change in HbA1c | HbA1c will be evaluated using point of care assessment | From baseline (day -11) to post-intervention (day 50) |
| Change in Body Weight | Body weight based on calibrated study scale | From baseline (day -11) to post-intervention (day 50) |
| Change in Body Mass Index (BMI) | kg/m^2 will be used to calculate BMI | From baseline (day -11) to post-intervention (day 50) |
| Fidelity to the Intended Intervention | Survey of care providers: what percent of content -- the intended intervention components -- were delivered | Post-intervention period (day 40 to day 50) |
| Change in Phase 2 CGM-derived Time in Range (TIR) | % time with glucose 70-180 mg/dL from post-intervention to 4-month follow-up | From post-intervention (day 40 to day 50) to follow-up (day 170 to day 180) |
| NOT COMPLETED |
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| BG001 | Self Directed Approach (SDA) | The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body Weight | Mean | Standard Deviation | Kgs |
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| HbA1c | Mean | Standard Deviation | % |
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| Time in Range | % time with glucose 70-180mg/dL | Mean | Standard Deviation | % of time with glucose 70-180mg/dL |
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| Self Directed Approach (SDA) |
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets. |
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| Secondary | 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. 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Post-intervention period (day 40 to day 50) |
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| Other Pre-specified | Change in CGM Derived % Time Above >180 mg/dL | % time above >180 mg/dL is considered a core CGM metric; time above range. This will be described as the 24-hour period | Posted | Mean | 95% Confidence Interval | % time in 24 hours | From baseline (day -11 to day 0) to post-intervention (day 40 to day 50) |
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| Other Pre-specified | Change in CGM-derived % Time Above >250 mg/dL | % time above >250 mg/dL is considered a core CGM metric; time above range. This will be described as the 24-hour period | Posted | Mean | 95% Confidence Interval | % time in 24 hours | From baseline (day -11 to day 0) to post-intervention (day 40 to day 50) |
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| Other Pre-specified | Change in CGM-derived % Time Below <70 mg/dL | CGM-derived % time <70 mg/dL is considered a core CGM metric; time below range This will be described as the 24-hour period | Posted | Mean | 95% Confidence Interval | % time in 24 hours | From baseline (day -11 to day 0) to post-intervention (day 40 to day 50) |
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| Other Pre-specified | Change in CGM-derived % Time in Tight Range (% Time With Glucose 70-140 mg/dL) | Time in tight range is considered another CGM metric. This will be described as the 24-hour period | Posted | Mean | 95% Confidence Interval | % time in 24 hours | From baseline (day -11 to day 0) to post-intervention (day 40 to day 50) |
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| Other Pre-specified | Odds Ratio for Participants Reaching CGM-derived Consensus Targets by Arm | Describes the odds ratio for participants who reach consensus target or >70% TIR (% time with glucose 70-180 mg/dL) | Posted | Number | 95% Confidence Interval | Odds ratio | From baseline (day -11 to day 0) to post-intervention (day 40 to day 50) |
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| Other Pre-specified | Change in Total Energy Intake | Energy intake will be calculated using 24 hour dietary recalls | Posted | Mean | 95% Confidence Interval | kilocalories | From baseline (day -11) to post-intervention (day 40 to day 50) |
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| Other Pre-specified | Change in Carbohydrate Intake | Carbohydrate intake will be calculated using 24 hour dietary recalls | Posted | Mean | 95% Confidence Interval | Grams | From baseline (day -11) to post-intervention (day 40 to day 50) |
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| Other Pre-specified | Change in Calcium Intake | Select micronutrient (calcium) intake will be calculated using 24 hour dietary recalls | Posted | Mean | 95% Confidence Interval | milligrams | From baseline (day -11) to post-intervention (day 40 to day 50) |
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| Other Pre-specified | Change in Total Diabetes Distress Scale-17 Score | 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. | Posted | Mean | 95% Confidence Interval | Composite score | From baseline (day -11) to post-intervention (day 50) |
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| Other Pre-specified | Change in HbA1c | HbA1c will be evaluated using point of care assessment | Posted | Mean | 95% Confidence Interval | % of glycated hemoglobin | From baseline (day -11) to post-intervention (day 50) |
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| Other Pre-specified | Change in Body Weight | Body weight based on calibrated study scale | Posted | Mean | 95% Confidence Interval | Kilograms | From baseline (day -11) to post-intervention (day 50) |
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| Other Pre-specified | Change in Body Mass Index (BMI) | kg/m^2 will be used to calculate BMI | Posted | Mean | 95% Confidence Interval | kg/m2 | From baseline (day -11) to post-intervention (day 50) |
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| Other Pre-specified | Fidelity to the Intended Intervention | Survey of care providers: what percent of content -- the intended intervention components -- were delivered | Posted | Mean | Standard Deviation | % of content delivered | Post-intervention period (day 40 to day 50) |
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| Other Pre-specified | Change in Phase 2 CGM-derived Time in Range (TIR) | % time with glucose 70-180 mg/dL from post-intervention to 4-month follow-up | N=50 in NFA due to withdrawals from the study and participants who did not provide adequate CGM data. N=52 in SDA due to withdrawals from the study and participants who did not provide adequate CGM data. | Posted | Mean | 95% Confidence Interval | % of day | From post-intervention (day 40 to day 50) to follow-up (day 170 to day 180) |
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| 0 |
| 50 |
| 2 |
| 50 |
| 0 |
| 50 |
| EG001 | Phase 2 - Self Directed Approach (SDA) | Phase 2 for SDA was an observational follow-up period only. Participants ended the SDA intervention and did not receive any study-related care during the follow-up period. They returned to the clinic at the end of follow-up for assessments only. The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets. | 0 | 52 | 1 | 52 | 0 | 52 |
| EG002 | Phase 1 - Nutrition Focused Approach (NFA) | Phase 1 for NFA was the active intervention period. NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations. | 0 | 64 | 0 | 64 | 0 | 64 |
| EG003 | Phase 1 - Self Directed Approach (SDA) | Phase 2 for SDA was the active intervention period. The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets. | 0 | 60 | 0 | 60 | 0 | 60 |
| Brain mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Mild epigastric tenderness | Gastrointestinal disorders | Systematic Assessment |
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| D004700 | Endocrine System Diseases |