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About This Study

The study is an open, prospective study to collect data on the efficacy and safety of T-DXd (DS8201) in Chinese patients with HER2 overexpressing and HER2 underexpressing advanced breast cancer in actual clinical practice in China. Cohort A: HER2 overexpressing patients with advanced breast cancer Cohort B: HER2 underexpressing patients with advanced breast cancer A total of 400 subjects will be enrolled in the program, with 200 enrolled in Cohort A and 200 enrolled in Cohort B. The study will be conducted by a physician in accordance with current clinical practice. The treatment plan will be recommended to the subjects by the treating physician based on the current clinical practice guidelines in conjunction with the clinical practice, and the patient's decision to be treated with T-DXd (DS8201) should precede enrollment in this study. Because of the non-interventional nature of this study, this study does not alter or interfere with clinician treatment decisions, and the actual medical practice of patients. Inclusion in the study after the first treatment with the drug is based on inclusion/exclusion criteria. Subject enrollment in this study should be within 2 months of the subject's first dose of medication and prior to the first efficacy assessment. Demographic data, past medical and treatment history, ECOG score, vital signs + physical examination, laboratory tests, objective tumor evaluation, coadministration/concomitant therapy, adverse events, time to progression/death, and subsequent antitumor therapy were collected at baseline, during treatment, and at subsequent follow-up. Imaging evaluation was performed according to RECIST 1.1 criteria. Adverse events evaluation criteria were based on NCI-CTCAE version 5.0.

Design

Interventions / Regimen

• Drug: T-DXd (DS8201) 5.4 mg/kg, IVD, 1 cycle every 21 days. — The treatment plan will be recommended to the subject by the treating physician in accordance with current clinical practice guidelines and clinical practice, and the patient's decision to receive T-DXd (DS8201) should precede enrollment in this study. The strategy for administering a particular treatment to a subject is not determined a priori by the trial protocol, but should be in accordance with current clinical practice. Because of the non-interventional nature of this study, this study does not alter or interfere with the patient's actual current medical practice.

Primary Outcomes

• To assess progression-free survival (PFS) of Chinese patients with advanced breast cancer with HER2 overexpression and HER2 underexpression treated with real-world T-DXd (DS8201). (through study completion, an average of 1 year)

About This Study

This is a single-center, randomized, open-label, phase II interventional study. Eligible patients will be randomized 1:1 to receive either Trastuzumab-rezetecan (4.8 mg/kg Q3W) or T-DXd (5.4 mg/kg Q3W) for 8 neoadjuvant cycles. After completing neoadjuvant treatment, patients will undergo definitive surgery, and tpCR will be assessed from resected specimens. Patients will then be followed up to monitor long-term efficacy (e.g., EFS) and late-onset adverse events. A total of 68 patients (34 per arm) will be enrolled to achieve the study's statistical objectives.

Design

Interventions / Regimen

• Drug: Trastuzumab rezetecan — Participants will receive Trastuzumab-rezetecan for 8 cycles
• Drug: Trastuzumab deruxtecan — Participants will receive Trastuzumab deruxtecan for 8 cycles

Primary Outcomes

• Pathological Complete Response Rate (3 to 8 weeks after neoadjuvant treatment completion)

About This Study

This is a prospective, single arm, open-label, exploratory study in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression), to evaluate the omission of surgery and sentinel lymph node dissection in patients with HER2-E and ERBB2 high breast cancer who achieving a complete response following standard anti-HER2-based neoadjuvant therapy with paclitaxel/trastuzumab/pertuzumab.

Design

Interventions / Regimen

• Drug: Pertuzumab and trastuzumab FDC subcutaneous — Pertuzumab and trastuzumab FDC subcutaneous, A loading dose of 1200 mg pertuzumab and 600 mg trastuzumab followed by a maintenance dose of 600 mg pertuzumab and 600 mg; day 1 of each 3 week cycle during 5 neoadjuvant cycles and 13 adjuvant cycles if complete response
• Drug: Paclitaxel — 80 mg/m2, day 1,8,15 of each 3 week cycle during 4 cycles
• Drug: TDM1 — 3,6 mg/kg, 14 adjuvant cycles if not complete response
• Drug: Endocrine therapy — Adjuvant endocrine therapy will be administered as per local practice and according to recognized clinical practice guidelines
• Procedure: Omission surgery — Omission of surgery and sentinel lymph node dissection in patients with HER2-E and ERBB2 high breast cancer who achieving a complete response following standard anti-HER2-based neoadjuvant therapy with paclitaxel/trastuzumab/pertuzumab

Primary Outcomes

• To estimate the loco-regional invasive disease-free survival of patients who achieve a complete response (3 years)

About This Study

Background: In a new cancer therapy, researchers take a person s blood, select a certain white blood cell to grow in the lab, and then change the genes of these cells using a virus. The cells are then given back to the person. This is called gene transfer. For this study, researchers will modify the person s white blood cells with anti-CD70. Objectives: To see if a gene transfer with anti-CD70 cells can safely shrink tumors and to be certain the treatment is safe. Eligibility: Adults age 18 and older diagnosed with cancer that has the CD70-expressing cancer. Design: Participants will be screened with medical history, physical exam, scans, and other tests. They may by admitted to the hospital. Leukapheresis will be performed. For this, blood is removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm. Eligible participants will have an intravenous catheter placed in their upper chest. Over several days, they will get chemotherapy drugs and the anti-CD70 cells. They will recover in the hospital. Participants will take an antibiotic for 6 months after treatment. They will repeat leukapheresis. Participants will visit the clinic every 1-3 months for the first year after treatment, every 6 months for the second year, and then as determined by their physician. Follow-up visits will take 1-2 days. At each visit, participants will have lab tests, imaging studies, and a physical exam. Throughout the study, blood will be taken and participants will have many tests to determine the size and extent of their tumor and the treatment s impact.

Design

Interventions / Regimen

• Drug: Cyclophosphamide — For Phase I, Days -7 and -6: Dose Level 1: 15 mg/kg/day x 2 days IV Dose Level 2: 15 mg/kg/day x 2 days IV Dose Level 3: 15 mg/kg/day x 2 days IV Dose Level 4: 15 mg/kg/day x 2 days IV Dose Level 5: 30 mg/kg/day x 2 days IV Dose Level 6: 60 mg/kg/day x 2 days IV For Phase II, Days -7 and -6: 60 mg/kg/day x 2 days IV
• Drug: Fludarabine — For Phase I, Days -7 to -5: Dose Level 1: 25 mg/m(2)/day x 3 days IVPB Dose Level 2: 25 mg/m(2)/day x 3 days IVPB Dose Level 3: 25 mg/m(2)/day x 3 days IVPB Dose Level 4: 25 mg/m(2)/day x 3 days IVPB Dose Level 5: 25 mg/m(2)/day x 5 days IVPB Dose Level 6: 25 mg/m(2)/day x 5 days IVPB For Phase II, Days -7 to -3: 25 mg/m(2)/day x 5 days IVPB
• Drug: Aldesleukin — Aldeskeukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 3 days (maximum 9 doses).
• Biological: Anti-hCD70 CAR transduced PBL — Day 0: Cells will be infused intravenously on the Patient Care Unit over 20-30 minutes (2-5 days after the last dose of fludarabine).

Primary Outcomes

• Frequency and severity of treatment-related adverse events (From time of cell infusion to two weeks after cell infusion)
• Response rate (6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per PI discretion)

About This Study

DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer

Design

Interventions / Regimen

• Drug: Trastuzumab deruxtecan — T-DXd: administered as an IV infusion
• Drug: Durvalumab — Durvalumab: administered as an IV infusion
• Drug: Paclitaxel — Paclitaxel: administered as an IV infusion
• Drug: Capivasertib — Capivasertib: administered orally
• Drug: Anastrozole — Anastrozole: administered orally
• Drug: Fulvestrant — Fulvestrant: administered as an IM injection
• Drug: Capecitabine — Capecitabine: administered orally

Primary Outcomes

• Occurrence of adverse events (AEs)- Part 1 (Up to follow-up period, approximately 24 months)
• Occurrence of serious adverse events (SAEs)- Part 1 (Up to follow-up period, approximately 24 months)
• Occurrence of adverse events (AEs)- Part 2 (Up to follow-up period, approximately 24 months)
• Occurrence of serious adverse events (SAEs)- Part 2 (Up to follow-up period, approximately 24 months)

About This Study

Prospective, observational cohort study looking at patients either at risk of breast cancer or have clinically suspected breast to assess the diagnostic performance of quantitative, non-contrast MRI.

Design

Interventions / Regimen

• Diagnostic Test: Outpatient MRI — Participation in the study includes up to a maximum of 2 study visits. The visits will include clinical measurements (height, weight, blood pressure), blood tests, MRI scan and patient symptoms and experience questionnaires. There will be no medical interventions as part of the study. All participants will receive standard-of-care by their healthcare provider/s. With the participant's consent, the participant's primary care physician will be made aware of their participation in the study. Furthermore, participants will be informed of any structural abnormalities found in the MRI scan (e.g. abnormal vessels, haemangioma, tumour, cyst, among others) and abnormal blood test results as these may have clinical implications. These will be managed by the routine clinical care team as part of standard care.

Primary Outcomes

• Determine the diagnostic performance of a non-contrast MRI in breast disease (36 months)

About This Study

The purpose of this research protocol is to measure Patient Reported Outcome Measures (PROMs) in breast cancer patients. PROM results will be provided to patients and providers and the investigators will evaluate the relationship between patient engagement with PROM results and patient and clinicopathologic variables, utilization of supportive and hospital services, and patient satisfaction with patient-provider communication.

Design

Interventions / Regimen

• Other: Patient Reported Outcome Measure Survey result feedback — Patients will receive a graph of their results from the PROM survey each time they complete a survey

Primary Outcomes

• BREAST Q patient satisfaction with breast surgeon domain (24 months)

About This Study

Preoperative chemotherapy has been shown to be at least as effective as postoperative chemotherapy in breast cancer patients and has seen increased use over time. The decision regarding neoadjuvant treatment is complex, as various aspects need to be considered, and the patient's role in the decision-making process is central. The information provided by doctors to patients about preoperative treatment can be complicated, including details about treatment options, treatment plans, and side effects. If this information is not conveyed adequately, there is a risk of misunderstandings, which can lead to increased anxiety and stress for patients regarding their decisions. In oncology, question prompt lists (QPL) have been used as a tool to support patients by improving the information conveyed by doctors in various contexts where complex decisions need to be made. Studies have shown that QPL can facilitate better information exchange. However, their use in discussions about preoperative treatment for breast cancer patients has not been studied. Furthermore, evidence from randomized studies on the use of QPL in clinical practice is very limited. The aim of this study is to investigate whether the use of QPL during patient consultations involving discussions about neoadjuvant chemotherapy can improve information exchange in various aspects: understanding of the treatment; anxiety about the decision; participation in the decision-making process; patient-doctor communication; and decision-related conflict.

Design

Interventions / Regimen

• Other: Question prompt list — The question prompt list includes 12 questions related to neoadjuvant therapy. It has been developed by an expert team including breast surgeons, oncologists, nurses, and psychologists and has been refined through focus interview with patient advocates and caregivers.

Primary Outcomes

• Concordance rate between patient and oncologist (Within five days from patient visit)

About This Study

HER2-positive and Triple-negative are subtypes of breast cancer more sensitive to systemic therapies, where the complete pathological response rate may be higher than 50%. This gave rise to doubts about the usefulness of traditional local treatments for such responders. Omission of surgery after vacuum assisted breast biopsy (VABB) as well omission of radiotherapy after conservative surgery would now seem to be reasonable alternatives to standard care for highly selected patients, in whom systemic treatments have provided the maximum response.

Design

Interventions / Regimen

• Other: Omission of local therapies — Omission of surgery (arm A) or radiotherapy (arm B) in those patients who have had the maximum response by neoadjuvant treatments. Maximum responders are those patients with no evidence of residual disease after neoadjuvant treatment at imaging -including mammography, US evaluation and contrast imaging procedures (MRI and/or CEM)-, confirmed by VABB on marked site of ascertained lesion. This study is open to all patients with T1-2, N0-1, M0 HER2-positive or triple negative breast cancer, treated with neoadjuvant systemic treatment, irrespective of treatments delivered.

Primary Outcomes

• Events-free survival (EFS) for each study arm. (5 years)

About This Study

The objectives of the re-examination system in Korea is to re-confirm the clinical usefulness of the product through collecting, reviewing, identifying and verifying the safety and efficacy information about the product in general practice in Korea. This surveillance is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws, the Regulations on Safety of Pharmaceuticals, etc. and the Re-examination Regulation for New Drugs and Others.

Design

Primary Outcomes

• Objective Response Rate (ORR) (From Day 1 through Day 7 after administration. Administration and for 28 days following. The total follow-up period will not exceed 1 year.)

About This Study

Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. The procedure will be carried out by a dedicated surgical team in which at least one operator holds certified laparoscopic surgical training issued by a recognized scientific society, ensuring appropriate technical expertise and adherence to surgical safety standards.

Design

Interventions / Regimen

• Procedure: Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) — Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. Recent prospective studies and meta-analyses have shown encouraging results in terms of technical feasibility, reduced flap-related complications, and higher patient satisfaction compared with the conventional open approach.

Primary Outcomes

• Rate of completion of the procedure endoscopically without conversion to open surgery. (At surgery)
• Surgery time (At surgery)
• Feasibility of immediate reconstruction (At surgery)

About This Study

A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Bevicizumab in HER2-low breast cancer with brain metastasis.

Design

Interventions / Regimen

• Drug: Bevacizumab (Bev) — Bevacizumab is a drug that targets vascular endothelial growth factor (VEGF) and inhibits tumor angiogenesis, thereby inhibiting tumor growth and spread. In the treatment of breast cancer, Bevacizumab can be used in combination with chemotherapy to improve treatment outcomes and extend patients' progression-free survival and overall survival.
• Drug: Trastuzumab Deruxtecan (T-DXd) — Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) composed of an anti-HER2 monoclonal antibody (trastuzumab), a cleavable linker, and a topoisomerase I inhibitor (an exatecan derivative). It targets and binds to HER2-positive tumor cells, internalizes, and releases cytotoxic drugs to induce DNA damage and apoptosis. It also has a "bystander effect" that can kill neighboring tumor cells with low HER2 expression, enhancing anti-tumor activity. T-DXd has shown significant efficacy in HER2-positive advanced breast cancer, with key clinical trials (such as DESTINY-Breast03) confirming that its progression-free survival (PFS) and overall survival (OS) are superior to traditional second-line treatments, with a median PFS reaching 28.8 months. Additionally, for HER2-low-expressing (IHC 1+ or 2+/ISH-) metastatic breast cancer (in the DESTINY-Breast04 study), T-DXd can extend PFS and OS, becoming the first targeted therapy to alter the survival outcomes of such patients.

Primary Outcomes

• Progression Free Survival(PFS) (12 months)

About This Study

This study will evaluate whether a precision navigation intervention can help community residents at high risk for cancer complete recommended cancer screening. The study will be conducted in communities participating in an urban cancer screening program in China. Eligible participants will be adults aged 45 to 74 years who are permanent residents of participating communities and have been identified as being at high risk for at least one of five cancers: lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, or liver cancer. Participants must not have completed the corresponding free clinical screening before enrollment. This is a dual-cohort, cluster randomized controlled trial. Communities, rather than individual participants, will be assigned to one of three groups: a precision navigation group, a usual health education group, or a waiting control group. Participants will be classified into two cohorts according to the number of cancers for which they are assessed as high risk. Cohort A will include participants at high risk for three or more cancers, and Cohort B will include participants at high risk for one or two cancers. Participants in the precision navigation group will receive a personalized navigation report matched to their risk profile. The report will explain the screening tests most relevant to them, help them understand screening choices, and provide practical steps to support screening completion. Participants in the usual health education group will receive general cancer screening education materials. Participants in the waiting control group will not receive active screening promotion during the main intervention period, but will receive general education materials after the primary assessment. The main outcome is whether participants complete the recommended cancer screening during follow-up. The study will also assess changes in screening-related decision conflict, anxiety, self-efficacy, and behavioral intention. The results may help improve community-based cancer screening programs and provide evidence for using personalized navigation strategies to increase screening participation among high-risk populations.

Design

Interventions / Regimen

• Behavioral: Precision Navigation Intervention — Participants in the precision navigation group will receive a personalized navigation report based on their cancer risk profile from the urban cancer screening program. The report will be tailored according to whether the participant is at high risk for three or more cancers or for one or two cancers. It will provide individualized information on high-risk cancer types, recommended screening tests, screening procedures, common barriers to screening, and practical action steps. Trained staff will provide a brief standardized explanation of the report and support participants in making a screening action plan.
• Behavioral: Usual Health Education — Participants in the usual health education group will receive general cancer screening education materials. The materials will provide basic information about cancer prevention, early detection, and screening for lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, and liver cancer. The content is not personalized according to the participant's individual risk profile.

Primary Outcomes

• Proportion of Participants Completing Recommended Cancer Screening (From enrollment to 6 months after enrollment)

About This Study

Cancer poses a major public health challenge in China. Early detection can improve treatment outcomes and survival rates. In this study, we will conduct a large-scale, prospective, multi-center cohort study to evaluate the utility of AI-assisted non-contrast CT for multi-cancer screening. The study aims to enroll 1 million asymptomatic participants undergoing routine health examinations, using an AI imaging model based on non-contrast CT to detect seven cancers such as lung, liver, gastric, colorectal, esophageal, pancreatic, and breast cancers. Positive cases will be required to be referred to Shanghai Changhai Hospital for further imaging and care based on National Comprehensive Cancer Network (NCCN) and American College of Radiology (ACR) guidelines. The goal is to assess the AI model's diagnostic performance for seven cancer types, especially for early-stage, resectable tumors.

Design

Interventions / Regimen

• Diagnostic Test: AI-Assisted Non-Contrast CT for Multi-Cancer Screening — Participants identified by the AI model as having potential cancerous lesions, including those suspected of lung, liver, gastric, colorectal, esophageal, pancreatic, and breast cancer, will be required to undergo blood tests (for tumor markers) and additional imaging studies (such as contrast-enhanced CT, MRI, Endoscopy, etc.) to confirm the diagnosis of cancerous lesions.

Primary Outcomes

• Diagnostic yield (3 years)
• Incidence (3 years)
• Resectable rate (3 years)

About This Study

To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor (primary breast tumor/axillary lymph nodes) who did not achieve pCR after neoadjuvant therapy

Design

Interventions / Regimen

• Drug: Pyrotinib+Trastuzumab+Capecitabine — Patients in the experimental arm will receive trastuzumab + pyrotinib + capecitabine
• Drug: Trastuzumab+Pertuzumab/Trastuzumab — Trastuzumab: Initial loading dose of 8 mg/kg followed by 6 mg/kg every 3 weeks. One year of trastuzumab treatment (including: neoadjuvant phase and adjuvant phase) Pertuzumab: 840 mg loading dose followed by 420 mg fixed dose

Primary Outcomes

• iDFS (3 years)

About This Study

Phase III, single-center, randomized, double-blind, placebo-controlled, 2x2 cross- over study, assessing the efficacy of CBD in patients with early HR+ BC, presenting aromatase inhibitor-related musculoskeletal pain

Design

Interventions / Regimen

• Drug: CBD oil — Patients will receive CBD-oral solution 2.5 mg/kg PO BID for a total of 12 weeks.
• Drug: Placebo — Patients will receive placebo for a total of 12 weeks.

Primary Outcomes

• Brief Pain Inventory - Short Form (BPI-SF) Interference score. (Baseline, 4 weeks, 12 weeks, 13 weeks, 17 weeks, 25 weeks, 37 weeks after starting treatment.)

About This Study

It's estimated that 50% of diabetic patients will have peripheral neuropathy as a complication within 3 years of the diabetes incidence \[14\], the goal of the study is to investigate this problem through the following objectives: 1. To measure the effect of using FREMS therapy in diabetic neuropathy in interventional group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline. 2. To measure the effect of using standard of care in diabetic neuropathy in control group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline. 3. To compare the results between both interventional and control group.

Design

Interventions / Regimen

• Device: frequency rhythmic electrical modulated stimulation. — FREMS is characterized by sequences of biphasic electrical stimuli, with 10 consecutive sessions applied on lower limb within 10:14 days, 40 minutes for each session.
• Drug: Duloxetine - low dose — peripheral neuropathy conventional treatment, 30:60mg orally once/day within 10:14 days.

Primary Outcomes

• Neuropathy severity (From enrollment to the end of treatment at 10:14 days)
• blood perfusion. (From enrollment to the end of treatment at 10:14days.)

About This Study

The current study aimed to thoroughly compare a thiazolidinedione and an sodium-glucose cotransporter-2 (SGLT2) inhibitor regarding various clinical issues including atherosclerosis. Enavogliflozin is compared to Pioglitazone in the glucose-lowering effects of adding to the treatment of patients with type 2 diabetes whose HbA1c levels are not controlled by Metformin with or without DPP-4 inhibitors. Additionally, the study will compare changes in other metabolic or cardiovascular risk factors, such as triglycerides, high density lipoprotein cholesterol (HDLc), uric acid, blood pressure, and inflammatory markers, between the two drugs.

Design

Interventions / Regimen

• Drug: Enavogliflozin — Enavogliflozin 0.3mg once daily
• Drug: Pioglitazone — Pioglitazone 15mg once daily

Primary Outcomes

• Changes of HbA1c from the baseline (24 weeks)

About This Study

The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients.

Design

Interventions / Regimen

• Other: Dulce Digital Text Messaging Intervention — Text-based education support program: * Participants will receive text messages about diabetes and how to take care of diabetes and health. Participants will receive 2-3 messages every day for first 3 months, and then will slowly decrease over the last 3-months. * Participants will also receive text messages that will ask them to test their blood sugar and text back blood sugar reading.
• Other: CGM Device — Participants will be provided continuous glucose monitors (Dexcom G7) to actively monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 18 devices to last up to 6 months). In addition, participants will attend an information session (group or individual; in-person or virtual) that will provide instructions on using continuous glucose monitors.

Primary Outcomes

• HbA1c (6 months)

About This Study

This is a randomized study comparing outcomes of patients diagnosed with Type 2 Diabetes (T2D) who are enrolled into the Twin Health Precision Treatment (TPT) system versus usual care. The study will last for a year with a 1 year optional extension for the TPT arm patients to continue for another year, and for the usual care (UC) patients to cross over to the TPT treatment for a year. 150 patients will be enrolled with 100 being randomized to the TPT arm and 50 being enrolled to the UC arm

Design

Interventions / Regimen

• Behavioral: Twin Precision Treatment — Combination of Artificial Intelligence algorithms based on daily sensor input and live nutrition, exercise, sleep and breath coaching to help treat type 2 diabetes

Primary Outcomes

• To compare the percentage of patients in the TPT and Usual Care groups who have a HbA1c less than 6.5 and are not on any glucose lowering medications (excluding Metformin up to 2000 mg/day) at 12 months (360 days). (360 days)