Society of Behavioral Medicine Annual Meeting, New Orleans, April 14, 2018. eHealth Carbohydrate-Reduced Diet and Lifestyle Programs for Adults with Type 2 Diabetes: Three Approaches

1. Society of Behavioral Medicine Annual Meeting, New Orleans,
April 14, 2018. eHealth Carbohydrate-Reduced Diet and Lifestyle
Programs for Adults with Type 2 Diabetes: Three Approaches
Effectiveness of Continuous Remote
Care and Nutritional Ketosis for Type 2
Diabetes
James McCarter MD PhD
Head of Research, Virta Health
@jpmccarter

2. Clinical Trial Design and Outcomes
Components of the Virta Intervention
Q&A
OUTLINE

4. Clinical Trial Design and Outcomes
Components of the Virta Intervention
Q&A
OUTLINE

5. Virta-IUH Clinical Trial Demonstrates
Reversal of Type 2 Diabetes Status at 1 Year
Hallberg et al. Diabetes Therapy, 2018.
McKenzie et al. JCL, 2018.
Blood Glucose Improvement
1.3% average HbA1c reduction, 70% below 6.5%
of completing patients
reverse diabetes
Glycemic Control without
use of diabetes-specific
medications
60% Medication Reduction
94% of insulin users reduced or eliminated usage
Weight Loss
12% average weight loss (30 pounds)
CVD Risk Improvement including Dyslipidemia
12% improvement in 10-year ASCVD Risk Score

6. Virta-IUH Clinical Trial
■ 5 year, non-randomized
prospective controlled study
■ 465 participants recruited
Aug 2015 - Mar 2016
■ Active arm n=378, of which
n=262 T2DMs
■ Usual care arm n=87
■ Central Indiana
■ Mean age: 54
■ Mean BMI: 40.3
■ Mean weight: 257 lbs.
■ Mean Yrs. T2D: 8.4
■ 67% female
6
Hallberg et al. Diabetes Therapy, 2018.
McKenzie et al. JCL, 2018.

7. 83% Engaged at 1 Year
Do patients stay
engaged?
Yes, 83% trial
retention
at 1 year
Hallberg et al. Diabetes Therapy, 2018.
McKenzie et al. JCL, 2018.

8. HbA1c reduced
profoundly,
diabetes
reversed in a
majority
Virta
Usual Care
6.2 avg
7.5 avg
Hallberg et al. Diabetes Therapy, 2018.
McKenzie et al. JCL, 2018.
Intent-to-treat
P < 1.0 X 10-16

9. Completers Pre-Post HbA1c, Virta vs. Usual Care
Virta Treatment Usual Care
Hallberg et al. Diabetes Therapy, 2018.
McKenzie et al. JCL, 2018.

10. n=63n=53 n=23 n=5 n=31 n=42 n=172
57% of prescriptions for diabetes-specific
medications were discontinued
Completers
McNemar Test
P < 1.0 X 10-16
Hallberg et al. Diabetes Therapy, 2018.
McKenzie et al. JCL, 2018.

11. Weight loss
averaged 12% and
was sustained at
one year.
● 80% of patients lost >5%
● 54% of patients lost >10%
Hallberg et al. Diabetes Therapy, 2018.
McKenzie et al. JCL, 2018.
Intent-to-treat
P < 1.0 X 10-16

12. 12% improvement in 10-year ASCVD risk score
Usual Care
Virta
Hallberg et al. Diabetes Therapy, 2018.
McKenzie et al. JCL, 2018.
Intent-to-treat
P = 4.9 X 10-5

13. Examining all available
cardiovascular risk biomarkers,
25 of 29 in Virta Treatment
show statistically significant
improvement versus
0 of 29 for Usual Care.
Usual Care
Virta
Hallberg et al. Diabetes Therapy, 2018.
McKenzie et al. JCL, 2018.
Intent-to-treat
For 25 significant changes
P < 0.0019

14. Clinical Trial Design and Outcomes
Components of the Virta Intervention
Q&A
OUTLINE

15. Telemedicine platform for
‘in your pocket,’
personalized physician and
coach care
Continuous
Remote Care
Medication management and
individualized guidance including
nutritional ketosis
Virta Clinical
Protocol
Two Sources of Innovation

16. Virta’s Continuous Remote Care Platform

18. Carb restriction to achieve
nutritional ketosis
Highly personalized
(socio-economic, cultural, religious)
Education & problem solving,
not meal delivery/replacement
Eat delicious, real foods
until satisfied, no calorie counting
Virta Nutritional Guidance

19. What is nutritional ketosis and why is it beneficial?
● Nutritional ketosis is a metabolic state in which the body is
predominantly fueled by fats from the diet or body fat stores
● Ketone bodies are natural products of liver fatty acid metabolism
● Ketone bodies increase during fasting or when dietary
carbohydrates are limited to < 30 g/day with moderate protein
● During fasting, ketones provide 60% of the brain’s energy needs
Benefits of ketosis arise from …
● Alternative energy with decreased reliance on glucose/insulin
“rollercoaster” especially in individuals with insulin resistance
● Hormonal properties of ketones signaling for reductions in
inflammation (NLRP3) and oxidative stress (HDAC)

20. Virta Feedback
Loop utilizes daily
monitoring of ...
● Blood ketones (beta
hydroxybutyrate)
● Blood glucose
● Weight (cell enabled scale)
● Mood & energy
● Hunger & cravings
● User activity
● Coach-driven interventions
supported by AI-prioritization

21. Virta health coaches focus on nutrition & behavior change
● Multi-disciplinary team of registered dietitians, nurses, clinical psychologists, etc.
● Coach-patient interactions average over 3 per day for 1st 70 days
● In early months, focus on daily nutritional guidance, medications & troubleshooting
● In later months, shift to navigating long-term behavior change & life events
● Later months include guidance on exercise, sleep, stress management, body image
● Health coach techniques include Cognitive Behavioral Therapy, S.M.A.R.T. goals,
Motivational Interviewing

22. Thank you to our co-authors and collaborators ...

23. Virta-IUH Clinical Trial Demonstrates
Reversal of Type 2 Diabetes Status at 1 Year
Hallberg et al. Diabetes Therapy, 2018.
McKenzie et al. JCL, 2018.
Blood Glucose Improvement
1.3% average HbA1c reduction, 70% below 6.5%
of completing patients
reverse diabetes
Glycemic Control without
use of diabetes-specific
medications
60% Medication Reduction
94% of insulin users reduced or eliminated usage
Weight Loss
12% average weight loss (30 pounds)
CVD Risk Improvement including Dyslipidemia
12% improvement in 10-year ASCVD Risk Score

24. Clinical Trial Design and Outcomes
Components of the Virta Intervention
Q&A
OUTLINE

25. Links to further information
www.virtahealth.com
@virtahealth, @jpmccarter
Job opportunities: virtahealth.com/careers
Diabetes Therapy paper: http://doi.org/10.1007/s13300-018-0373-9