If overweight adolescents between the age of 10 and 17 years with type 2 diabetes are enrolled in a population care program, what level of "successful" management can be expected? Will some, half or most of these adolescents achieve blood glucose control?The depressing answer may be found in the just published "TODAY" study. Youngsters with type 2 diabetes, a body mass index (BMI) at the 85th percentile and a committed adult caregiver were randomly assigned to one of three treatment protocols: 1) the first line drug metformin (up to 1000 mg twice a day) versus 2) metformin plus an individually delivered lifestyle program versus 3) metformin plus another diabetes drug rosiglitazone twice a day. After a baseline 2-6 month "run in period" of basic diabetes education combined with the metformin, 699 kids were then randomly assigned to one of the three arms of the study.
Over an average of 3.8 years of follow up, 49% of the metformin group (N=232), 53% of the metformin plus lifestyle (N=234) and 62% of the of the metformin plus rosiglitazone group (N=233) managed to keep their HbA1c persistently below 8%. When the three outcomes were compared, only the difference between metformin alone vs. metformin plus rosiglitazone was statistically significant. What's more, the participants in all three treatment arms collectively experienced a slight increase in weight, though the metformin plus lifestyle experienced the least weight gain. Race was inversely associated with glucose control: across all three groups. 48% of blacks vs. 55% of Hispanics vs 64% of whites stayed within the A1c range.
What are the implications for the population health management service providers?
1) Based on this rigorously conducted study, diabetic adolescents age 10-17 cannot be expected to achieve the same level of blood glucose control as similarly treated adults, who can expect success rates in the 80-85% range. This should be factored into any peformance guarantees outside of research settings, especially if tighter A1c levels of 7% are used.
2) Ditto Patient Centered Medical Homes and any pay for performance (P4P) incentives that focus on diabetes care: kids are different.
3) Persons of color are more vulnerable and are at higher risk.
4) While the twin drug approach of metformin plus rosiglitazone "beat" metformin plus lifestye instruction, the difference was not statistically significant. This supports using metform plus lifestyle as an initial approach before additional (and potentially dangerous as well as expensive) drugs are added to the metformin.
5) A serious shortcoming of this study was not adding a fourth treatment arm for comparison: two drugs plus lifestyle instruction. It stands to reason that any lifestyle intervention plus any drugs should achieve better blood glucose control than either alone.
Image from the CDC website
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