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

Viome

Status: Unknown

Conditions: Diabetes; Pre-diabetes; Diabetes Type 2

Treatments: Behavioral: VIOME Precision Nutrition Program

Study type: Interventional

Funder types: Industry

Identifiers

NCT04905485

V136 (VIOME-001 v5.0)

Details and patient eligibility

About

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.

Enrollment: 2,912 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2,912 participants in 1 patient group

Intervention

Other group

Description:

All participants received the intervention in this trial. They received recommendations on their diets and supplements based on their results of microbiome expression.

Treatment:

Behavioral: VIOME Precision Nutrition Program