DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07032311

SIPPA-QH_HHC-2

Not yet recruitingPhase NA

Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk

Effect of Behavioral Intervention/Therapy to Reduce Diabetes and Liver Disease Risk Through Prescribed Digital Therapeutics Enabled by AI/ML Powered Predictive Analytics

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

—

Enrollment

200

estimated

Study population

Prediabetes / glucose intolerance, Type 2 diabetes

Key I/E criterion

•HbA1c 5.8-6.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07032311
Org study IDSIPPA-QH_HHC-2025-S1

Timeline

Milestones

Study first posted2025-06-23actual
Last update posted2025-06-23actual
Study start2025-07-01estimated
Primary completion2026-12-31estimated
Study completion2027-06-30estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Prediabetes / glucose intoleranceType 2 diabetes

Eligibility

Who can enroll

Minimum age22 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•English Proficiency with a Middle-school Reading Level
•Owning a smartphone or obtaining one on-loan basis during the study period, with a data plan and/or the ability to receive text messages
•Possess basic skills to operate an (Android) smartphone, if you want to receive behavior intervention/therapy in addition to the standard care service
•Willingness to Modify Behavior, Physical activity, and diet
•Age 22 to 65
•Diagnosed with diabetes and prediabetes with two or more blood work results since 2021 revealing alanine aminotransferase (ALT), aspartate aminotransferase (AST), and platelet count (ICD-10 code; Prediabetes: R73.03, Diabetes: E08-E13); whereas prediabetes is clinically defined as two consecutive measure of A1C between 5.8 and 6.5
•Willing to communicate with the project team via phone, email, or SMS once a week

Exclusion criteria

Consume more than one and a half times the limit of alcohol recommended for the population (15g/day for women and 30 g/day for men) (ICD-10 code: K70.9)

•Pregnancy (ICD-10 code: Z33.3)
•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)
•Cardiovascular Events in the Past 6 Months and Symptomatic Heart Failure (ICD-10 code: I.21, I.25, I.50, I63.9)
•Stage 4 and Above Chronic Kidney Disease (CKD) and End-Stage Renal Disease (ESRD)(ICD-10 code: N18.4, N18.5, N18.6)
•Untreated Hypothyroidism (ICD-10 code: E03.9)
•Depression (ICD-10 code: F32.A)
•A patient who already received a digital behavioral intervention/therapy prescribed by a clinician is ineligible for this study for safety considerations.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Change in Hemoglobin A1c (HbA1c)

Time frame:Baseline to 6 months after randomization

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.