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Multimodal Glucose Prediction in Type 2 Diabetes

5. juni 2026 opdateret af: Johns Hopkins University

CGM- and Behavior-based Large Health Model for Just-in-time Diabetes Management

The primary objective of this research, funded by Samsung Strategic Alliance for Research and Technology, is to develop multi-modal foundation models that integrate Continuous Glucose Monitoring (CGM) data with patient behavior data (food intake, medication, and physical activity) to improve real-time glucose prediction and personalized diabetes management for patients with Type 2 diabetes (T2D), delivered via mobile apps and digital health tools.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

36

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Nestoras Mathioudakis, MD, MHS
  • Telefonnummer: 410-955-3663
  • E-mail: nmathio1@jhmi.edu

Undersøgelse Kontakt Backup

  • Navn: Gordon Gao, PhD
  • Telefonnummer: 410-234-9450.
  • E-mail: ggao8@jh.edu

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins Medicine
        • Kontakt:
          • Nestoras Mathioudakis, MD, MHS
          • Telefonnummer: 410-955-3663
          • E-mail: nmathio1@jhmi.edu
        • Kontakt:
          • Gordon Gao, PhD
          • Telefonnummer: 410-234-9450.
          • E-mail: ggao8@jh.edu
        • Ledende efterforsker:
          • Nestoras Mathioudakis, MD
        • Ledende efterforsker:
          • Gordon Gao, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants will be selected from the Johns Hopkins Medicine adult clinical population. The study population will include adults with type 2 diabetes who receive diabetes care through Johns Hopkins Medicine, including primary care and endocrinology clinics. Participants will be recruited from patients whose routine diabetes care includes use of continuous glucose monitoring and who may be eligible to contribute glucose, wearable, app-based behavioral, and electronic medical record data for development and validation of glucose prediction models.

Beskrivelse

Inclusion Criteria:

  • 18-75 years old
  • Registered patient under Johns Hopkins Medicine (JHM)
  • Type 2 Diabetes diagnosis
  • Diabetes managed by a primary care physician or endocrinologist at JHM
  • Android Smartphone user
  • Must have a Dexcom G7 or FreeStyle Libre 3 CGM and using a mobile app to access their CGM data (G7 or Libre 3 apps)
  • 2 weeks of usage (with at least 50% wear time) prior to study participation required
  • CGM Time in Range of <70% in 14 days prior to enrollment
  • Must be able to read, understand, and communicate in English
  • Must not have hearing or vision impairments
  • Willingness to Download the Welldoc app
  • Agree to wear a SAMSUNG Galaxy Watch at least 12 hours per day
  • Download SAMSUNG Health (Non-SAMSUNG Phone user)
  • Download Google Health Connect
  • Use CGM at least 80% of the time
  • Take a photo of all meals

Exclusion Criteria:

  • Pregnant
  • Non-English speaker
  • Has hearing or vision impairment
  • Use of an insulin pump (i.e. automated insulin delivery system)
  • Diagnosed with other forms of diabetes (e.g. Type 1 Diabetes, Latent Autoimmune Diabetes in Adults (LADA), Maturity-Onset Diabetes of the Young (MODY), or Gestational diabetes)
  • Non-Android smartphone user (i.e., Apple iOS)
  • CGM time-below-range > 4% (i.e. hypoglycemia) in the 14 days prior to enrollment.
  • Hospitalization for Diabetic Ketoacidosis (DKA) or severe hypoglycemic episode within the previous 6 months.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Adults With Type 2 Diabetes Using CGM
Adults with type 2 diabetes receiving care through Johns Hopkins Medicine will participate in a single site observational cohort study. Participants will continue usual diabetes care and will not receive a treatment intervention from the study team. Participants will contribute CGM, smartwatch, app-based behavioral, and electronic medical record data for development and validation of glucose prediction models. Study-generated messages and summary reports will be reviewed by the study team and will not be delivered to participants.
Enhed: Digital Health Data Collection System
Participants will use a digital health data collection system that includes the Welldoc app, a Samsung smartwatch, and the participant's existing continuous glucose monitor. The system will collect CGM data, smartwatch-derived activity, sleep, and vital sign data, and app-based behavioral information such as meals, physical activity, and medication use. Participants will continue usual diabetes care and will not receive treatment recommendations from the study team. Data will be used to develop and validate glucose prediction models and Artificial Intelligence (AI)-generated research outputs that will be reviewed by the study team and not delivered to participants.
Andre navne:
  • Kontinuerlig glukosemonitor
  • Dexcom G7
  • Welldoc
  • Samsung Galaxy Watch
  • FreeStyle Libre 3

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Root Mean Square Error of CGM Glucose Prediction Model
Tidsramme: Up to 3 Month follow-up
Model performance will be evaluated using root mean square error to compare predicted continuous glucose monitor glucose values with observed continuous glucose monitor glucose values. Model performance using continuous glucose monitor data alone will be compared with model performance using continuous glucose monitor data plus behavioral measures, including physical activity and diet logs.
Up to 3 Month follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Meal Logs Submitted Per Participant
Tidsramme: Up to 3 Month follow-up
The total number of meal logs submitted by each participant in the study app will be summarized. A higher number indicates more frequent meal logging.
Up to 3 Month follow-up
Number of Physical Activity Logs Submitted Per Participant
Tidsramme: Up to 3 Month follow-up
The total number of physical activity logs submitted by each participant in the study app will be summarized. A higher number indicates more frequent physical activity logging.
Up to 3 Month follow-up
Number of Medication Logs Submitted Per Participant
Tidsramme: 3 month follow-up
The total number of medication logs submitted by each participant in the study app will be summarized. A higher number indicates more frequent medication logging.
3 month follow-up
Number of Mood Logs Submitted Per Participant
Tidsramme: Up to 3 Month follow-up
The total number of mood logs submitted by each participant in the study app will be summarized. A higher number indicates more frequent mood logging.
Up to 3 Month follow-up
Percent of Expected Continuous Glucose Monitor Data Captured Per Participant
Tidsramme: Up to 3 Month follow-up
The percentage of expected continuous glucose monitor data captured during the study period will be summarized for each participant. A higher percentage indicates greater continuous glucose monitor use.
Up to 3 Month follow-up
Mean Daily Samsung Smartwatch Wear Time Per Participant
Tidsramme: Up to 3 Month follow-up
Mean daily Samsung smartwatch wear time will be summarized as the average number of hours per day that each participant wears the Samsung smartwatch. A higher number indicates greater smartwatch wear.
Up to 3 Month follow-up
Percent of Study Days With Study App Use Per Participant
Tidsramme: Up to 3 Month follow-up
The percentage of study days with any recorded study app use will be summarized for each participant. A higher percentage indicates greater study app use.
Up to 3 Month follow-up
Clinician-Rated Accuracy of Artificial Intelligence-Generated Content as Assessed by a Study-Specific 5-Point Likert Scale
Tidsramme: 3 month follow-up
Artificial intelligence-generated research content will be reviewed by the study team for accuracy using a study-specific 5-point Likert scale. Scores range from 1 to 5, with higher scores indicating greater accuracy. These outputs will not be delivered to participants.
3 month follow-up
Clinician-Rated Safety of Artificial Intelligence-Generated Content as Assessed by a Study-Specific 5-Point Likert Scale
Tidsramme: 3 month follow-up
Artificial intelligence-generated research content will be reviewed by the study team for safety using a study-specific 5-point Likert scale. Scores range from 1 to 5, with higher scores indicating greater safety. These outputs will not be delivered to participants.
3 month follow-up
Clinician-Rated Communication Quality of Artificial Intelligence-Generated Content as Assessed by a Study-Specific 5-Point Likert Scale
Tidsramme: 3 month follow-up
Artificial intelligence-generated research content will be reviewed by the study team for communication quality using a study-specific 5-point Likert scale. Scores range from 1 to 5, with higher scores indicating better communication quality. These outputs will not be delivered to participants.
3 month follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johns Hopkins University

Samarbejdspartnere

Welldoc
Samsung Research America

Efterforskere

  • Ledende efterforsker: Nestoras Mathioudakis, MD, MHS, Johns Hopkins University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

15. januar 2027

Studieafslutning (Anslået)

26. februar 2027

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00523137

Plan for individuelle deltagerdata (IPD)

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