The randomized type 2 diabetes prevention trial addresses the knowledge gap



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medwireNewsLifestyle intervention significantly reduces the risk of type 2 diabetes in people who have prediabetes based on measurements of fasting glucose (FPG) or glycated hemoglobin (HbA1c), results from a randomized study show.

National diabetes prevention programs, such as those in the United States and the United Kingdom, admit participants based on elevated levels of FPG or HbA1c, usually from a single measurement. However, the intervention evidence used as the basis for these programs was based on people with impaired glucose tolerance, and the belief that people classified according to FPG or HbA1c will also benefit is a hypothesis with little supporting evidence.

Sampson and the team have now addressed this information gap with the randomized Norfolk Diabetes Prevention Study (NDPS), which recruited people with two separate FPG tests initially of 110 mg / dL (6 mmol / L) or greater at less than 126 mg. / dL (7 mmol / L), with the trough subsequently reduced to 100 mg / dL (5.5 mmol / L), or an FPG test coupled with an HbA1c measurement of 6.0% or greater to less than 6 , 5% (≥42 to <48 mmol / mol).

“The effect size we saw was roughly the same as in large, intense randomized controlled trials in patients with impaired glucose tolerance,” said study lead author Michael Sampson (Norfolk and Norwich University Hospital NHS Trust, UK) medwireNews.

All of these studies showed a risk reduction of about 40% over 2 years, he said, “but our intervention was much less intense, it was group-based, and much less expensive.”

As reported in JAMA Internal Medicine, the intervention was similar to that used in national prevention programs and involved six 2-hour educational group sessions over 12 weeks, followed by up to 15 maintenance sessions held every 8 weeks. The average cost per person was only US $ 153 (€ 129).

During an average follow-up of 24.7 months, 13.7% of the 403 participants who attended at least one intervention session developed type 2 diabetes, as did 15.0% of the 414 who attended same sessions and received additional telephone support from people with established type 2 diabetes.

In comparison, 22.8% of the 171 participants who continued with their usual care developed diabetes, providing an estimated annual incidence of 6.4% and 7.1% versus 11.0%, respectively. equal to a reduced probability of approximately 45% that intervention participants will develop type 2 diabetes, also additional adjustment for factors including duration of follow-up, age, BMI and FPG.

There were no significant differences in participants’ likelihood of benefiting from the intervention based on their age, gender, BMI, or deprivation quartile.

The combined intervention group achieved an average of 1.76 kg of weight loss at 12 months, which Sampson found to be similar to that reported by the UK’s national diabetes prevention program. “So it is very likely that the national program will also show benefits” in terms of diabetes prevention, he said.

The researchers had hoped that additional support from people with established type 2 diabetes, who share challenges and experiences with study participants, would add value, but there was no significant difference in outcomes between the groups. and without this support.

“We think it’s probably because the effect size was already so large with just standard surgery there was no more room for further change,” Sampson said. “But we could find something very different with the type 2 diabetes study, which we will publish shortly.”

He explained that during the screening, the team identified about 400 people with previously undiagnosed type 2 diabetes. These people were randomized into the same treatment groups as people with prediabetes on the basis that they would benefit.

This will be the topic of an upcoming publication, with “some very interesting findings,” Sampson said, and implications for health policy.

“What we have is an intervention that can be applied to both prediabetes and type 2 diabetes on the screen – it’s a standard program that you can use across the spectrum.”

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2020 Springer Healthcare Ltd, part of Springer Nature Group

JAMA Intern Med 2020; doi: 10.1001 / jamainternmed.2020.5938

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