Effect of Behavioral Intervention/Therapy to Reduce Diabetes and Liver Disease Risk Through Prescribed Digital Therapeutics Enabled by AI/ML Powered Predictive Analytics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change in Glycated Hemoglobin (HbA1c)
研究概览
简要总结
This clinical trial aims to find out if a digital behavioral program, delivered through the SIPPA digital therapeutics app, can help improve blood sugar control and lower the risk of liver fibrosis in adults with type 2 diabetes who are at low to moderate risk for liver disease.
Main Research Question:
Can adding the SIPPA behavioral program to standard diabetes care lower HbA1c (a marker of blood sugar control) more than standard care alone?
Study Design:
The study has two groups (called "arms") for comparison:
Intervention Arm (Arm I):
Receives personalized behavioral therapy through the SIPPA Health app alongside Standard of Care (SOC). Participants in this arm complete standardized onboarding and technical readiness training at the start.
Control Arm (Arm C):
Receives Standard of Care (SOC) alone.
What Participants Will Do:
All participants will have lab tests at the start of the study, at baseline, 3 months, and at 6 months. These tests include:
- HbA1c (a measure of average blood sugar levels),
- Fib-4 score (used to estimate liver fibrosis risk), and
- Liver enzyme tests.
Participants in the intervention group (Arm I) will also:
- Use the SIPPA app daily to complete behavioral modules, track blood sugar
- levels, and log health behaviors (like diet and activity).
- Have weekly check-ins with a health navigator to support progress and stay on track with their diabetes treatment plan.
详细描述
Study Purpose and Objectives This study is designed to evaluate whether a smartphone-based behavioral intervention, called SIPPA Health, can enhance the effects of standard diabetes care-including for patients who are prescribed GLP-1 receptor agonists (a common injectable diabetes medication). SIPPA Health, guided by behavioral predictive analytics, delivers daily lifestyle coaching through an app, including exercise goals, meal logging, glucose tracking, and weekly remote check-ins with a trained health navigator.
The study will examine whether adding SIPPA to standard treatment improves blood sugar control, reduces liver fibrosis risk, supports weight management, and helps personalize diabetes care through digital tools. Specific objectives include:
Glycemic Control: Measure changes in hemoglobin A1c (HbA1c)-a long-term blood sugar marker between those who use the SIPPA app and those who receive standard care alone.
Liver Health: Measure Fibrosis-4 (Fib-4) index, an estimate of liver scarring, between those who use the SIPPA app and those who receive standard care alone.
Population-level Diabetes Risk Indicator: Assess whether there is a difference in the distributions between SIPPA users and patients receiving only standard care service; where the distribution will consider BMI change, A1c progression, glucose variability (time-in-range), and engagement with self-care activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label trial; no participants, investigators, outcome assessors, or data analysts are blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age Threshold: Age ≥ 18 years at the time of informed consent.
- •Clinical Diagnosis: Confirmed diagnosis of Type 2 Diabetes Mellitus (ICD-10: E11.-) supported by: For Type 2 Diabetes: Baseline screening HbA1c above 7.0% (excluding insulin-dependent patients unlikely to benefit from adjunct behavioral intervention).
- •Medication Stability: Stable pharmacological regimen with no new diabetes medications or dose changes within 90 days of screening. GLP-1 receptor agonists or SGLT-2 inhibitors are permitted only if stable ≥ 90 days prior to screening (status will be captured as a stratification variable).
- •Clinical Oversight: Currently under the care of a licensed physician or Certified Diabetes Care and Education Specialist (CDCES).
- •Language & Literacy: English language proficiency with at least a middle-school reading level, sufficient to independently engage with the SIPPA Health application content.
- •Device Ownership & Connectivity: Owns a compatible Android smartphone (or willingness to accept an Android smartphone on a loan basis during the study period) with an active data plan and/or the ability to reliably send and receive text messages. Note: the current validated platform is Android; iOS subjects are not eligible in this study version.
- •Digital Literacy: Possess the basic technical skills required to operate an Android smartphone and navigate Android mobile applications to receive behavioral intervention/therapy in addition to standard care.
- •Behavioral Commitment: Expressed willingness to modify behavior, physical activity, and diet, alongside a commitment to communicate with the project team via phone, email, or SMS at least once a week.
- •Informed Consent: Capable of providing written informed consent.
排除标准
- •Current insulin therapy, excluding stable basal insulin (stable ≥ 90 days prior to screening), (ICD Z79.4)
- •GLP-1 receptor agonist or SGLT-2 inhibitor initiated or dosage change within 90 days of screening (ICD Z79.899)
- •Type 1 Diabetes Mellitus (ICD E10.9)
- •Severe renal impairment (eGFR < 30 mL/min/1.73m²) (ICD N18.4)
- •Active malignancy or life expectancy < 12 months (ICD C00 to C96, C51.5)
- •Active major depressive episode, psychosis, or inpatient psychiatric care within 12 months (ICD F32.A, F32.9, F29, Z65.8)
- •Pregnancy or active breastfeeding (Z33.1, Z39.1)
- •Concurrent enrollment in another interventional digital health or behavioral modification study (ICD Z00.6)
- •Prior use of BT-001 (Better Therapeutics) or SIPPA Health within 6 months of screening
- •Receiving Hepatotoxic Medication (ICD-10 code: K76.1)
- •Cirrhosis, Hepatitis B/C, and Other Chronic Liver Diseases (ICD-10 code: K.74, B19.10, B19.20, K72.1)
研究组 & 干预措施
ARM 1: Control Arm (Control - Standard of Care Alone)
Participants assigned to Arm C receive Standard of Care (SOC) diabetes management alone according to routine clinical practice guidelines, with no exposure or access to the SIPPA Health application during the 24-week core trial (Period 1).
Participants undergo protocol-specified clinical and laboratory evaluations at baseline, Week 12 (3 months), and Week 24 (6 months). Following completion of the Week 24 primary endpoint evaluation, participants in Arm C are offered an optional rollover into the 24-week Open-Label Extension (Period 2), where they receive active adjunctive SIPPA Health therapy alongside SOC through Week 52.
AMR I: Intervention Arm (Intervention - SIPPA Health + Standard of Care)
Participants assigned to Arm I receive software-based, personalized digital behavioral therapy delivered via the SIPPA Health mobile application adjunctively with Standard of Care (SOC) diabetes management.
Upon allocation, participants undergo an onboarding session to establish app access. During the 24-week core trial (Period 1), participants utilize the app daily to complete personalized behavioral modules, log self-monitored blood glucose/health habits, and receive weekly non-clinical support from a health navigator. Following the Week 24 primary endpoint assessment, participants continue receiving active adjunctive SIPPA Health therapy through Week 52 in the Open-Label Extension (Period 2) to assess long-term safety, sustained engagement, and within-person HbA1c trajectories.
干预措施: Behavioral Treatment (Device)
结局指标
主要结局
Change in Glycated Hemoglobin (HbA1c)
时间窗: Baseline to 6 months after randomization
Hemoglobin A1c is reported as a percentage (%) of glycosylated hemoglobin, with typical values ranging from approximately 4% (normal) up to \>14% (poor control). Higher percentages indicate worse long-term glycemic control. Our primary outcome metric is the absolute difference in percentage points (e.g., a decrease from 8.1% at baseline to 7.2% at six months reflects a change of -0.9 percentage points). Evaluates the clinical efficacy of SIPPA Health used adjunctively with Standard of Care (SOC) compared to SOC alone on glycemic control. HbA1c is measured via standardized blood laboratory assay at baseline and Week 24. A negative change indicates an improvement in blood sugar control.
Change in Hemoglobin A1c (HbA1c)
时间窗: Baseline to 6 months after randomization
Hemoglobin A1c is reported as a percentage (%) of glycosylated hemoglobin, with typical values ranging from approximately 4% (normal) up to \>14% (poor control). Higher percentages indicate worse long-term glycemic control. Our primary outcome metric is the absolute difference in percentage points (e.g., a decrease from 8.1% at baseline to 7.2% at six months reflects a change of -0.9 percentage points).
次要结局
- Change from Baseline in Body Weight(Baseline to Week 24)
- Proportion of Participants Achieving Glycemic Target (HbA1c < 7.0%)(Week 24)
- Change from Baseline in Self-Efficacy Survey Score(Baseline to Week 24)