DiRECT trial: can type 2 diabetes go into remission in one year?

Why this study matters

Type 2 diabetes is usually treated as a lifelong condition. The DiRECT trial tested a different idea: that a structured program of meal replacement, food reintroduction and long-term support, run through family practices, could push diabetes into remission. Remission here means blood sugar back below the diabetes range without diabetes medicines.

Who was in the study

The trial took place at 49 family practices in Scotland and the Tyneside area of England. Participants were 20 to 65 years old. They had been diagnosed with type 2 diabetes within the past six years and were not using insulin. Their BMI, which is weight in kilograms divided by height in metres squared, was 27 to 45. In total, 306 people were recruited. The main analysis, called intention to treat, included 149 people in each group. This report covers the first 12 months.

What the researchers did

This was an open-label, cluster-randomized trial. Cluster-randomized means whole practices, not individual people, were assigned by chance to one of two approaches. Twenty-three practices delivered the program and 26 delivered usual care. Open-label means participants and their care teams knew which approach they were getting.

The program had four parts. First, diabetes and blood pressure medicines were withdrawn under clinical supervision. Second, participants used a total diet replacement, a formula diet providing 825 to 853 kcal per day, for 3 to 5 months. Third, ordinary food was reintroduced in steps over 2 to 8 weeks. Fourth, structured support continued to help maintain weight loss.

The comparison group received guideline-based usual care. No weight-loss medicine was part of either group.

The two main outcomes were losing at least 15 kg, and diabetes remission, defined as an HbA1c below 6.5% after at least two months off all diabetes medicines. HbA1c is a blood test that reflects average blood sugar over about three months.

What they found

At 12 months, 36 people in the program group (24%) had lost 15 kg or more. No one in the usual-care group did. Diabetes remission was reached by 68 people in the program group (46%) and 6 in the usual-care group (4%) (R32-C92). The odds ratio was 19.7 (95% confidence interval 7.8 to 49.8). An odds ratio compares the odds of an outcome between two groups, and the confidence interval is the range within which the true value would likely fall.

Average weight fell by 10.0 kg in the program group and 1.0 kg in the usual-care group. The adjusted difference was -8.8 kg (95% confidence interval -10.3 to -7.3), where the minus sign means more weight lost with the program.

Remission tracked closely with how much weight a person lost, across both groups combined:

Quality of life, on a rating scale, rose by 7.2 points in the program group and fell by 2.9 points in the usual-care group, an adjusted difference of 6.4 points (2.5 to 10.3).

Side effects and people who stopped

Nine serious adverse events were reported by 7 of 157 people (4%) in the program group, and two by 2 people (1%) in the usual-care group. Two events in the same person, biliary colic (gallbladder pain) and abdominal pain, were judged possibly related to the program. No serious adverse event led anyone to leave the study. The summary does not report how many people stopped the program for other reasons.

What this study does not tell you

• It was open-label, so participants knew their group. That can affect behaviour and reporting.
• Practices, not people, were randomized. This design can leave more differences between groups than person-level randomization.
• Only people with diabetes for less than six years who were not on insulin took part. Results may not apply to longer-standing diabetes.
• Medicines were stopped under medical supervision as part of the program. This is not something the trial says people should do on their own.
• One year is a short time. The two-year report shows how many people stayed in remission.
• Our summary is based on the abstract and extracted data, not the full paper.

What it means in Canada

DiRECT was run through UK family practices, which differ from Canadian primary care. It suggests remission is possible for some people with a recent diagnosis when a structured program with medical oversight is available. It did not use weight-loss medicines. For information on medicines used with type 2 diabetes in Canada, see semaglutide in Canada and tirzepatide in Canada. For coverage, see public drug coverage by province. To find structured programs, see compare services.

Related reading

Other studies in this library that bear on the same question.

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