Patients enrolled in this arm will receive diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center.

Patients enrolled in this arm will receive routine diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center, with lab testing, medical interventions, therapies and referrals performed at the discretion of the patients' providers. In the usual care model, behavioral/mental health and social work services are available on a referral basis and are not integrated into a patients' routine appointment. Screening and treatment of psychosocial determinants of diabetes management are at done at the discretion of the patients' provider. Frequency of follow up visits is at the discretion of the patients' provider.

Usual Care Model

Patients enrolled in this arm will receive diabetes care per the diabetes collaborative care model for young adults.

We designed a diabetes collaborative care model for young adults that incorporates a mental health provider alongside a diabetes care provider during joint office visits to facilitate screening and treatment of psychosocial determinants of diabetes management. The Massachusetts General Hospital (MGH) Diabetes Center will be piloting this model with a multi-disciplinary team of diabetologists, nurse practitioners, diabetes nurse educators, and mental health provider. Patients scheduled to be seen in the diabetes collaborative care model will continue to follow in the diabetes collaborative care model, with follow up visits every 3-4 months. All patients will receive routine diabetes care with lab testing, medical interventions, therapies and referrals performed at the discretion of the patients' providers.

Diabetes Collaborative Care Model for Young Adults

Patients are assigned a community health worker for the first year in addition to standard diabetes care. They do not receive a community health worker for the second year of the study.

A Community Health Worker will be added to the diabetes team caring for a child with new onset type 1 diabetes for 1 year. The intervention includes social determinants of health screening and goal setting, with home visits.

Community Health Worker added to diabetes team

Participants randomized to the control group will receive enhanced pre-release diabetes education with registered or licensed practical nurse-delivered diabetes education about medications and insulin administration supplemented with the literacy tailored diabetes education packets used in the principal investigator's prior research.

Enhanced Education

Because eight avatars plus the educator avatar are allowed in the VE classroom at one time, we will cap enrollment for the feasibility study to allow for CHW and CDE training and the opportunity to work together during LIVE JustICE sessions. The DSMES will consist of six synchronous 1-hour education sessions and an hour support session for participants living in supervised community housing in the experimental group. We will run the six-week series sequentially a total of eleven times over 18 months. LIVE JustICE sessions will be held conveniently for participants, and days/times rotated if needed.

Diabetes LIVE JustICE will be an adaptation of the current Diabetes LIVE persistent multi-user online virtual environment built on the Unreal Engine (Epic Games, Inc., Cary, NC) that allows users to talk to each other in real-time and participate in instructor-led synchronous sessions. Users can access the virtual environment through IOS/Android devices. Instructors can show learning material such as Google Docs and PowerPoint. The LIVE JustICE community will contain a community center, a tranquility center, and a message board. This will be an interactive community where participants will communicate in real-time on their mobile device or, if preferred, using their computer via text or audio chat. Access to LIVE will allow participants to utilize resources and links in the application, leave a message on the message board for the diabetes educators, or engage with other participants. Research team members will add and trial gaming activities to the VE during this feasibility study.

Diabetes LIVE JustICE

Louise A Reagan, PhD

Stephen J Walsh, ScD

Stephen J Walsh, PhD

The intervention group will have immediate access to the SUPPORT platform.

All participants accepting the SUPPORT study will receive the full intervention for 6 months. Their learning is individualized depending on the way they take their insulin (injection or pump) and the way they measure their blood sugar (finger prick or continuous glucose monitoring).

The training program starts with mandatory module on hypoglycemia. Once completed, participants will unlock all level 1 (out of 3 levels) modules from the 6 categories (medication, blood sugar monitoring, nutrition, physical activity, hypo- and hyperglycemia, health and other situations). The platform contains functionalities such as discussion forum, quizzes, videos, downloadable forms, etc. During the first 6 months, participants will receive a bi-weekly newsletter to inform them about what's new on the platform.

SUPPORT online platform for people with type 1 diabetes

All subjects participating in the diabetes prevention program will be offered body composition analysis and liver fat analysis, before, during, and after the lifestyle intervention

DPP lifestyle intervention program DSMT education on diabetes and lifestyle changes

Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT)

Hedia Diabetes Assistant is an insulin bolus calculator app designed to calculate an insulin bolus dose recommendation for people with type 1 or type 2 diabetes on rapid-acting insulin treatment.

Hedia Diabetes Assistant

Claire Briet, Dr.

Charles Thivolet, Professor

Samy Hadjad

Samy Hadjad, Professor

Ingrid Julier, Dr.

Lois Potier, MD, PhD

Xavier Piquel, Professor

Participants will be a part of the Diabetes Prevention Program (DPP), and additionally, as a participant in the the SCAN program, will receive live online instructional video sessions and email links that provide additional training information. Participants will also receive produce delivery.

Three instructional live video sessions will be provided to participants via live videoconferencing. The session will describe fundamentals for preparing produce for cooking, healthy approaches to cooking foods, a review of serving sizes, reading labels, and different classes of health foods. The nutrition education is designed to promote healthy dietary patterns for all by empowering participants to navigate healthy eating through the lens of their own food and cultural experiences. By emphasizing culinary techniques over recipes, instructors can inspire adaptability of culturally familiar flavors and ingredients for a diverse range of ethnicities, abilities, and cooking equipment.

Live instructional video sessions

This online information will supplement and reinforce the information presented in the live instructional video sessions.

Links to educational videos

The Diabetes Prevention Program (DPP) is a lifestyle change program intended to stop the onset of type 2 diabetes. The program involves Lifestyle Coaches, who help participants make and maintain the lifestyle changes that can help prevent type 2 diabetes. The Lifestyle Coaches share information about diabetes prevention, debunk fitness and health myths, and encourage fitness and healthy eating in regular group sessions. They also work with participants individually on personalized weight loss and exercise goals and action plans, using the group as a source of support and encouragement.

Diabetes Prevention Program (DPP)

The investigators partnered with the Houston Food Bank (HFB) to offer up to 30 pounds of fresh produce twice per month to all DPP participants through a food prescription (Food Rx) program.

Produce Delivery

Participants will be a part of the Diabetes Prevention Program (DPP) and will also receive produce delivery.

The University of Texas Health Science Center, Houston

Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.

Web-based telehealth intervention focused on adherence barriers and problem-solving

Diabetes Journey

Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.

General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.

Enhanced Standard of Care

Children's Hospital Medical Center, Cincinnati

Diabetes detection

Centre Hospitalier Universitaire de la Réunion

Catherine MARIMOUTOU, MD

Laetitia BERLY, PhD

Two interventions are performed:

1. Have Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score calculated, and if Score is \>0,
2. Have abdominal imaging performed.

ENDPAC is a model to risk-stratify patients with new onset diabetes and hyperglycemia for PDAC. Score is calculated using i) age, ii) change, over past year, in body weight and iii) change, over past year, in glucose/HbA1c values obtained from the electronic medical record.

Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score

Using computerized tomography (CT) scan or magnetic resonance imaging (MRI), if CT scan is contra-indicated, patients with a high ENDPAC score (\>0) are approached for informed consent to participate in the imaging intervention. Imaging (CT scan) is performed at up to two time points, study baseline and approximately 3-9 months following the first imaging study.

Abdominal imaging

Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis.

Participants randomized to the immediate intervention group will participate in 3 video-conferencing sessions with a Certified Diabetes Care and Education Specialist (CDCES) interventionist and connect with a peer parent consultant immediately post randomization (expected intervention duration: 3 months).

Intervention sessions will include parent/child discussion about barriers to CGM use, review of CGM data, problem solving, and working as a team.

diabetes education and parent coaching support

Participants randomized to the delayed intervention group will receive no intervention for 6 months post-randomization; after the 6-month follow-up period, the delayed intervention group also will participate in 3 video conferencing sessions with a CDCES interventionist and connect with a peer parent consultant (expected intervention duration: 3 months).

Control Arm: Study participants attending one of the 4 control arm centers will receive usual diabetes education provided by staff at the site; be provided with free test strips for their blood glucose meters during the 4-week intervention period; given access to the MODD application at the end of the study. Instructions on how to use the MODD will be provided by site staff.

Intervention: Mobile Diabetes Detective (MoDD) Study participants attending one of the 4 Intervention sites will receive usual diabetes education provided by staff at the site and be given access to the MODD application and instructions for use for 4 weeks at the beginning of the study. After the initial 4 weeks of access to the MODD application, participants will be offered an option to continue using MODD for the duration of the study.

MoDD is a web-based application that is designed to help individuals with diabetes identify specific problems related to glycemic control, and engage in problem-solving process. MoDD includes a number of messages that explain its users the nature of various problems related to glycemic control, aspects of individuals' behaviors that might have contributed to these problems, and alternative behaviors that could help to improve glycemic control. In addition to these messages displayed on the MoDD website, study participants may receive SMS messages with reminders to test blood glucose, or to follow the selected new behavior.

Mobile Diabetes Detective (MoDD)

Five weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7).

Culturally tailored diabetes self-management education

Adult Hispanic males 18-64 at time of study intervention

Participants in this arm follow standard of care procedures.

Participants diabetes technology devices will be linked to a remote patient monitoring dashboard and will have access to a Smartphone application, as well as scheduled and as needed visits with a community health worker.

Glucosano is a remote patient monitoring diabetes dashboard with a patient facing Smartphone application

Glucosano

Community Health Workers will work with participants as a diabetes technology coach during scheduled and as needed visits

Community Health Worker diabetes technology coach

Julie Hutter, RN

Terri Casey, RN, CDCES

Sarah A MacLeish, DO

Jamie R Wood, MD

Katherine Kutney, MD

Sarah Ronis, MD, PhD

Rebecca Hazen, PhD

Participants in this arm received enhanced usual care only. Enhanced usual care consisted of standard diabetes education, health coaching, and routine clinical management provided by their existing healthcare providers. No additional study-delivered classes, coaching, or materials were provided. Participants completed study assessments on the same schedule as the intervention group.

Participants received enhanced usual diabetes care. This included optional diabetes self-management education provided through routine clinic services, individualized health-coaching sessions provided at neighborhood health hub facilities focused on general diabetes management support. In addition, participants received four produce vouchers valued at $50 each to promote access to fresh fruits and vegetables. No additional study-delivered classes, dietary programming, or supplemental food items were provided.

Enhanced Usual Diabetes Care

Participants in this arm received a structured, multicomponent diabetes remission intervention promoting healthy eating and intensive weight loss in addition to usual care. The intervention included biweekly group sessions over the study period, covering nutrition and weight management; cooking classes; individual health coaching; 3-month diet replacement; and physician-supervised medication discontinuation. The program also included goal-setting, progress check-ins, and supportive accountability delivered by health coaches. Participants completed the same study assessments as the enhanced care arm.

An intensive multicomponent diet and weight-loss intervention designed to support diabetes remission. The program included biweekly group sessions focused on low-carbohydrate, moderate-fat nutrition strategies; portion and calorie guidance; behavior-change skills; goal-setting; and weight-tracking. Participants also completed biweekly individual health-coaching sessions that provided personalized dietary guidance, problem-solving support, and adherence monitoring. The intervention incorporated 12 weeks of weekly total diet replacement provided through home delivery of lower-carbohydrate, lean-protein food items to facilitate adherence to dietary goals. During the total diet replacement phase participants also received physician-supervised medication discontinuation. Physical activity recommendations and strategies for managing blood glucose were also covered. The intervention was delivered by health coaches and provided in addition to participants' usual clinical care.

Intensive Multicomponent Healthy Eating and Weight Loss Intervention

A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.

The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.

1. Training health workers on diabetes and hypertension treatment protocols
2. Team-based care and task sharing
3. Strengthening access to medications and diagnostics
4. Electronic medical record system and registry
5. Systems monitoring and feedback of key indicators

Integrated Diabetes and Hypertension Primary Care Model

A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.

The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.

1. Training health workers on diabetes and hypertension treatment protocols
2. Team-based care and task sharing
3. Strengthening access to medications and diagnostics
4. Electronic medical record system and registry
5. Systems monitoring and feedback of key indicators

Health care providers will administer this intervention to patient participants and will report on their experience.

Integrated Diabetes and Hypertension Primary Care Model - Providers

Participants in this group will follow the current standard international clinical guidelines, targeting a glycemic range of 3.9-10.0 mmol/L (70-180 mg/dL). They will receive the same level of structured multidisciplinary education and clinical follow-up as the intervention group, but calibrated to the standard 70-180 mg/dL range.

A comprehensive standardized guideline will be provided to recruiting physicians from all centers, including the points below:

1. Understanding CGM data and trend interpretation
2. TIR or TING concepts according to randomization, target range, consequences of hypoglycemia and hyperglycemia
3. Recognizing and management of hypoglycemia
4. Recognizing and management of hyperglycemia
5. Setting and adjusting of glycemic targets, alarms in CGM and insulin pumps, and insulin doses based on randomisation
6. Emotional coping strategies and involving family support

Structured Diabetes Education

Participants in this group will target a tighter glycemic range of 3.9-7.8 mmol/L (70-140 mg/dL). Their CGM and insulin pump settings will be adjusted by their physician to support this narrower range. Participants will receive structured education focused on achieving this tighter target.

For the TING group, CGM hyperglycemia target settings will be lowered by at-least 10% from the baseline values. The extent of the adjustment will be at the discretion of the attending physician

Automated Insulin Delivery (AID) System Adjustment

Shenali Amaratunga

Agnieszka Szypowska

Eligible participants will utilize the workbook for a span of 3 months

The diabetes self-management workbook section used in this pilot study will focus on diet management, specifically carbohydrates, following ADA guidelines. It will include exercises based on the ADA diabetes plate method, aimed at helping subjects understand meal planning, food categories, portion sizes, goal setting, and the impact of foods on blood glucose levels. Activities will include word searches, crosswords, and goal-setting exercises. Subjects will begin the first section during a clinic visit. They can complete the workbook at home over three months, with input from subjects and Certified Diabetes Care and Education Specialists to refine the content.

Diabetes self management workbook

Support and guidance of Diabetes Navigator in addition to standard care

Participants in the Diabetes Navigator (DN) arm will receive support from a trained navigator to help them improve progression (improving use/optimization) in use of advanced diabetes technology. The Diabetes Navigator will engage with participants immediately after randomization, throughout the duration of study, using a predefined toolkit, educational resources and interventions to assist them in optimizing use of advanced diabetes technology.

Diabetes Navigator

Standard care provided by the healthcare staff during routine diabetes clinic visits.

Practices randomised to the Medicare Claims Feedback arm received period feedback on their performance on selected diabetes quality of care measures as reflected in the claims data for their diabetes patients.

Physician practices received periodic feedback on their performance on selected diabetes quality of care measures as reflected by the Medicare claims data for their patients.

Medicare Claims Feedback

Practices randomised to the Medicare Claims + Medical Record Review Feedback arm received periodic feedback on their performance on selected diabetes quality of care measures as reflected in both the Medicare claims for the diabetes patients AND review/audit of their diabetes patients' medical records.

Physician practices received period feedback on their performance on selected diabetes quality of care measures, as reflected by data collected from their patients' medical records. These data were compiled by trained nurse abstractors using a standardized data collection tool developed for this study.

Medical Record Review

In addition to the performance data from both Medicare Claims data and from review of patients' medical records, practices randomised to the Medicare Claims + Medical Record review + Diabetes Resource Nurse (DRN) had a diabetes resource nurse assigned to them, who was available to provide diabetes education and care-coordination type services for their diabetes patients.

Diabetes Resource Nurses (DRNs) were registered nurses with 3-5 years of experience as certified diabetes educations who performed initial patient assessments, developed plans of care, administered screening tools, and monitored clinical outcomes. Physicians at the practices randomised to this intervention had could access the DRN's services for their diabetes patients, but neither physicians nor patients had to take advantage of this resource.

청년 성인을 위한 당뇨병 협력 치료 모델, 일반 치료 모델

지역사회 보건 담당자가 당뇨병 관리팀에 합류했습니다.

당뇨병 LIVE Justice, 강화된 교육

1형 당뇨병 환자를 위한 온라인 플랫폼 지원

당뇨병 예방 프로그램(DPP), 당뇨병 자가 관리 교육(DSMT)

헤디아 당뇨병 보조원

라이브 교육 비디오 세션, 교육 비디오 링크, 당뇨병 예방 프로그램(DPP), 농산물 배달

당뇨병 여정, 향상된 치료 표준

당뇨병 감지

췌장암에 대한 신규 발병 당뇨병(ENDPAC) 점수 강화, 복부 영상

당뇨병 교육 및 부모 코칭 지원

이동식 당뇨병 탐정(MoDD)

문화적 배경에 맞춘 당뇨병 자가 관리 교육

글루코사노, 지역 보건 종사자 당뇨병 기술 코치

집중적인 다성분 건강식단 및 체중 감량 중재, 강화된 일반 당뇨병 관리

통합 당뇨병 및 고혈압 1차 진료 모델, 통합 당뇨병 및 고혈압 1차 진료 모델 - 제공자

체계적인 당뇨병 교육, 자동 인슐린 투여(AID) 시스템 조정

당뇨병 자가 관리 워크북

당뇨병 네비게이터

메디케어 청구 피드백, 의료 기록 검토, 당뇨병 전문 간호사