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Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes

Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04905485
Enrollment
2912
Registered
2021-05-27
Start date
2021-05-21
Completion date
2023-12-31
Last updated
2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Type 2, Pre-diabetes

Keywords

Viome, Diabetes Type 2, Diabetes, Pre-diabetes, VPNP, Nutrition, Supplements, Precision

Brief summary

Participants who were previously Viome costumers who signed informed consent to participate and self reported type 2 diabetes or pre-diabetes were enrolled. They provided stool samples to VIOME and were provided with precision diet and supplement recommendations. The information obtained from this study is used to train a model to predict diabetes and/or risks of developing diabetes.

Interventions

Precision diet and supplement recommendations based on participants' microbiome results.

Sponsors

Viome
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Participants all received diet and supplement recommendations based on their microbiome results.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Viome customer * GI test collected at home using Viome test kit * US citizen * 18+ years old * Is not participating in any other Viome study * Must have answered the following on-boarding question with the indicated answer: Do you or did you ever have diabetes or prediabetes? * Signed and dated informed consent prior to any trial-specific procedures are performed * Able to speak and read English * Willing and able to follow the trial instructions

Exclusion criteria

* Unable/unwilling to complete the informed consent form and the questionnaires

Design outcomes

Primary

MeasureTime frameDescription
Difference in VIOME's Type 2 diabetes risk score~3 monthsType 2 diabetes risk score is computed using Viome's molecular data from stool and HBA1C level self reported. The risk score is 1-100. 1 Indicates a low chance of developing T2D and 100 indicates a high chance of developing T2D.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026