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O estudo clínico NCT07005362 (FIT T2D) para Diabetes tipo 2, Diabetes Mellitus Tipo 2 (T2DM), DM2 (Diabetes Mellitus Tipo 2), DM2 (Diabetes Mellitus Tipo 2), DM2, Remote Patient Monitoring, Artificial Intelegence está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Universidade do Colorado em DenverFitbit and AI Chatbot in Sedentary Primary Care Patients With T2D (FIT T2D)
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07005362 (FIT T2D) é um ensaio observacional para Diabetes tipo 2, Diabetes Mellitus Tipo 2 (T2DM), DM2 (Diabetes Mellitus Tipo 2), DM2 (Diabetes Mellitus Tipo 2), DM2, Remote Patient Monitoring, Artificial Intelegence. Seu status atual é: recrutando. O estudo começou em 3 de setembro de 2025 e pretende incluir 36 participantes. Coordenado por a Universidade do Colorado em Denver e deve ser concluído em 30 de abril de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 13 de novembro de 2025.
Resumo
The goal of this observational study is to evaluate the feasibility and acceptability of a 12-week intervention utilizing a Fitbit and artificial intelligence (AI)-delivered diabetes self-management education and support (DSMES) with tailored text messages.
The main question it aims to answer is:
Does providing a wearable fitness and activity tracker plus AI-tailored and DSMES improve clinical outcomes for patients with type 2 diabetes?
Participants will complete a baseline visit, wear a Fitbit and answer text messages for 12-weeks, and complete by a final visit.
Título oficial
Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings
Condições
Diabetes tipo 2Diabetes Mellitus Tipo 2 (T2DM)DM2 (Diabetes Mellitus Tipo 2)DM2 (Diabetes Mellitus Tipo 2)DM2Remote Patient MonitoringArtificial IntelegenceOutros IDs do estudo
- FIT T2D
- 24-2577
Número NCT
Data de início (real)
2025-09-03
Última atualização postada
2025-11-13
Data de conclusão (estimada)
2026-04-30
Inscrição (estimada)
36
Tipo de estudo
Observacional
Status
Recrutando
Palavras-chave
type 2 diabetes
artificial intelligence
fitbit
primary care
remote patient monitoring
physical activity
artificial intelligence
fitbit
primary care
remote patient monitoring
physical activity
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Experimental: Fitbit and AI Chatbot Participants will wear their Fitbit devices daily and receive personalized messages from the AI Chatbot weekly with setting a new exercise goal based on their previous week's activity level. Additionally, they can engage with the AI Chatbot through text message for further support, education, and goal setting. Participants will interact throughout the week on completing their goal or where they might improve. | Fitbit and AI Chatbot Participants will wear their Fitbit devices daily for 12-weeks and will receive personalized messages from the AI Chatbot every week with a new exercise recommendation based on their previous week's activity level. Additionally, they can engage with the AI Chatbot through text message for further support and education. |
Active Comparator: Controls The control group will be established through a rigorous retrospective chart review of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention. | Cuidado rotineiro The control group will consist of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Feasibility - Recruitment | Recruitment of 36 adults within 6 months. | 6 months |
Feasibility - Retainment | Retainment of 85% of participants for post-assessments. | 6 months |
Feasibility - Fitbit wear | Fitbit wear ≥ 5 days/week \> 12 hours per day, wear at night \> 3 nights/week. | 12 Weeks |
Feasibility - Text message responses | Responding to 80% of text messages when prompted. | 12 Weeks |
Feasibility - Technical issues | Participation with ≤10% technical issues (battery life, data sync between device and app/dashboard, device failure). | 12 Weeks |
Acceptability - Participant Experience and Satisfaction | Obtaining \> 60% satisfaction from participants via a satisfaction survey. | 12 Weeks |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Change in HbA1c | Change in HbA1c from baseline to post-intervention. | 12 Weeks |
Change in Body Mass Index | Change in Body Mass Index (BMI) from baseline to post-intervention. | 12 Weeks |
Change in lipid panel | Change in lipid panel from baseline to post-intervention. | 12 Weeks |
Change in weight | Change in weight from baseline to post-intervention. | 12 Weeks |
Change in blood pressure | Change in blood pressure from baseline to post-intervention. | 12 Weeks |
Change in diabetes distress | Change in diabetes distress as measured by the T2-DDAS: The Type 2 Diabetes Distress Assessment System from baseline to post-intervention. | 12 Weeks |
Experience with technology | Patient experience with technology as measured via the System Usability Scale (SUS). | 12 Weeks |
Experience with technology | Patient experience with technology as measured via the FACETS Comfort with Technology assessment. | 12 Weeks |
Cost | Cost of delivering remote patient monitoring intervention as measured via time-diaries and patient logs. | Weekly, 12 weeks |
Revenue | Revenue modeling from practice perspective of remote patient monitoring intervention as measured via staff and patient time logs. | Weekly, 12 weeks |
Critérios de elegibilidade
Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
18 Years
Sexos elegíveis
Todos
- Diagnosed with type 2 diabetes per investigator discretion
- No more than 20% of the sample will have A1c < 7.5% (confirmed by medical record review or an A1c completed within 3 months of the screening visit)
- Age ≥18 years and ≤ 80 years
- Does not meet ADA guidelines for physical activity (< 150 minutes of aerobic exercise per week defined as any activity where the participant can talk but not sing)
- Has a smartphone compatible with a Fitbit
- Completing more than 60 minutes of moderate to vigorous activity per week defined as activity where you cannot sing (moderate) or can't say more than a few words without gasping for breath (vigorous)(14)
- Any medical condition which, in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders.
- Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12- months
- Any planned surgery during the study which could be considered major in the opinion of the investigator
- Blood disorder or dyscrasia within 3 months before screening, or the use of hydroxyurea, which, in the investigator's opinion, could interfere with the determination of HbA1c
- Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the study, as they may interfere with the determination of HbA1c.
- Planning to move from Colorado within 3 months
- Current Pregnancy or planning on pregnancy in the next 3 months
- Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision that impacts ability to see FitBit, impaired memory)
- Unable to speak English as this is a small feasibility study that does not have the resources to adapt the intervention for Spanish
- Current participation in another diabetes-related clinical trial
Universidade do Colorado em Denver491 estudos clínicos ativos para explorarAmerican Academy of Family PhysiciansContato central do estudo
Contato: Jessica Parascando, MPH, 303-724-9525, [email protected]
Contato: Elizabeth Westfeldt, BSN, RN, [email protected]
1 Locais do estudo em 1 países
Colorado
University of Colorado, Anschutz, Aurora, Colorado, 80045, United States
Recrutando