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

Not Applicable

• Conditions: Diabetes; Diabetes Type 2; Pre-diabetes
• Interventions: Behavioral: VIOME Precision Nutrition Program

• Registration Number: NCT04905485
• Lead Sponsor: Viome

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-21
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-27
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-08
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2912

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	VIOME Precision Nutrition Program	All participants received the intervention in this trial. They received recommendations on their diets and supplements based on their results of microbiome expression.

Primary Outcome Measures

Name	Time	Method
Difference in VIOME's Type 2 diabetes risk score	~3 months	"Type 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.

Trial Locations

Locations (1)

Viome Research Institute; 🇺🇸 Bothell, Washington, United States