Nutritional Ketosis Intervention Referral for Type 2 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Type 2 DiabetesVirta Health - Behavioral
Eligibility
18 - 79
All Sexes
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Study Summary

This study is evaluating whether a virtual lifestyle intervention may help improve glucose control in individuals with type 2 diabetes.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Group 1: baseline, 3.5 months and 7 months / Group 2: 3.5 months and 7 months

3.5 months
Change in hemoglobin A1c (Percent)
Continuation of referral in Group 1 versus acceptance of referral in Group 2
Month 7
Count of 2-way contacts among subjects
Month 10
Change in hemoglobin A1c
Baseline and 3.5 months
Acceptance/continuation of referral to continuous remote care
Month 5
Acceptance of referral to continuous remote care
Month 10
Change in LDL-cholesterol
Change in fasting glucose
Change in fasting triglyceride/HDL ratio
Change in number and/or doses of anti-hyperglycemic medications • doses of anti-hyperglycemic medications
Month 10
Change in BMI
Month 10
Change in diabetes treatment satisfaction
Change in perceived health status
Month 7
Acceptability of referral
Acceptability of referral over time

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Nutritional Ketosis Intervention Referral
1 of 2
CHHS Standard Care - Delayed Referral to Nutritional Ketosis Intervention
1 of 2

Active Control

60 Total Participants · 2 Treatment Groups

Primary Treatment: Nutritional Ketosis Intervention Referral · No Placebo Group · N/A

Nutritional Ketosis Intervention Referral
Behavioral
ActiveComparator Group · 1 Intervention: Virta Health · Intervention Types: Behavioral
CHHS Standard Care - Delayed Referral to Nutritional Ketosis Intervention
Behavioral
ActiveComparator Group · 1 Intervention: Virta Health · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: group 1: baseline, 3.5 months and 7 months / group 2: 3.5 months and 7 months

Who is running the clinical trial?

Colorado Prevention CenterLead Sponsor
9 Previous Clinical Trials
11,208 Total Patients Enrolled
Virta HealthIndustry Sponsor
4 Previous Clinical Trials
50,917 Total Patients Enrolled
Cecilia Low Wang, MDPrincipal InvestigatorCPC Clinical Research
1 Previous Clinical Trials
16 Total Patients Enrolled

Eligibility Criteria

Age 18 - 79 · All Participants · 7 Total Inclusion Criteria

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