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

Sponsor

Viome (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04905485

Collaborator

(none)

2,912

Enrollment

Location

Arm

31.3

Anticipated Duration (Months)

92.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Type 2 Diabetes Pre-diabetes	Behavioral: VIOME Precision Nutrition Program	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

2912 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 21, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention All participants received the intervention in this trial. They received recommendations on their diets and supplements based on their results of microbiome expression.	Behavioral: VIOME Precision Nutrition Program Precision diet and supplement recommendations based on participants' microbiome results. Other Names: VPNP

Arm

Intervention/Treatment

Other: Intervention

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

Behavioral: VIOME Precision Nutrition Program

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

Other Names:

VPNP

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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