Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial

Background: Tight, targeted control of modifiable cardiovascular risk factors can reduce cardiovascular complications and mortality in individuals with type 2 diabetes (T2DM) and microalbuminuria. The effects of using an electronic “Prompt” with a treatment algorithm to support a treat-to-target approach has not been tested in primary care. Methods: A multi-centre, cluster-randomised trial among primary care practices across Leicestershire, UK. Primary outcome was proportion of individuals achieving systolic and diastolic blood pressure (<130 and <80mmHg, respectively) and total cholesterol (<3.5mmol/l) targets at 24 months. Secondary outcomes included proportion of individuals with HbA1c<58 mmol/mol (<7.5%), changes in prescribing, change in albumin-creatinine ratio, major adverse cardiovascular events, cardiovascular mortality and coding accuracy. Results: 2721 individuals from 22 practices, mean age 63 years, 41% female, 62% from Black and Minority Ethnic groups, completed two years follow-up. There were no significant differences in the proportion of individuals achieving the composite primary outcome, although the proportion of individuals achieving the pre-specified outcome of total cholesterol <4.0 mmol (Odds Ratio 1.24(1.05,1.47),p=0.01) increased with intensive intervention compared to control. Coding for microalbuminuria increased relative to control (Odds Ratio 2.05 (1.29, 3.25), p< 0.01]). Conclusions: Greater improvements in composite cardiovascular risk factor control with this intervention compared to standard care were not achieved in this cohort of high-risk individuals with T2DM. However, improvements in lipid profile and coding can benefit patients with diabetes to alter the high risk of atherosclerotic cardiovascular events. Future studies should consider comprehensive strategies including patient education and healthcare professional engagement, in the management of T2DM.

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Correction to: Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

International Journal of Obesity ◽

10.1038/s41366-021-00976-2 ◽

2021 ◽

Author(s):

Sharon A. Simpson ◽

Elinor Coulman ◽

Dunla Gallagher ◽

Karen Jewell ◽

David Cohen ◽

...

Keyword(s):

Pregnant Women ◽

Weight Management ◽

Healthy Eating ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Management Intervention ◽

Cluster Randomised ◽

Weight Management Intervention ◽

In Pregnancy

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Effects of an electronic software ‘prompt’ with healthcare professional training on cardiovascular and renal complications in a multi-ethnic population with Type 2 Diabetes and Microalbuminuria (The GP Prompt study): results of a pragmatic cluster randomised trial.

10.2337/figshare.12114174.v1 ◽

2020 ◽

Author(s):

Andrew Willis ◽

Winston Crasto ◽

Laura J Gray ◽

Helen Dallosso ◽

Ghazala Waheed ◽

...

Keyword(s):

Type 2 Diabetes ◽

Primary Care ◽

Cardiovascular Risk ◽

Odds Ratio ◽

Cardiovascular Events ◽

Primary Outcome ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Cluster Randomised

Background: Tight, targeted control of modifiable cardiovascular risk factors can reduce cardiovascular complications and mortality in individuals with type 2 diabetes (T2DM) and microalbuminuria. The effects of using an electronic “Prompt” with a treatment algorithm to support a treat-to-target approach has not been tested in primary care. Methods: A multi-centre, cluster-randomised trial among primary care practices across Leicestershire, UK. Primary outcome was proportion of individuals achieving systolic and diastolic blood pressure (<130 and <80mmHg, respectively) and total cholesterol (<3.5mmol/l) targets at 24 months. Secondary outcomes included proportion of individuals with HbA1c<58 mmol/mol (<7.5%), changes in prescribing, change in albumin-creatinine ratio, major adverse cardiovascular events, cardiovascular mortality and coding accuracy. Results: 2721 individuals from 22 practices, mean age 63 years, 41% female, 62% from Black and Minority Ethnic groups, completed two years follow-up. There were no significant differences in the proportion of individuals achieving the composite primary outcome, although the proportion of individuals achieving the pre-specified outcome of total cholesterol <4.0 mmol (Odds Ratio 1.24(1.05,1.47),p=0.01) increased with intensive intervention compared to control. Coding for microalbuminuria increased relative to control (Odds Ratio 2.05 (1.29, 3.25), p< 0.01]). Conclusions: Greater improvements in composite cardiovascular risk factor control with this intervention compared to standard care were not achieved in this cohort of high-risk individuals with T2DM. However, improvements in lipid profile and coding can benefit patients with diabetes to alter the high risk of atherosclerotic cardiovascular events. Future studies should consider comprehensive strategies including patient education and healthcare professional engagement, in the management of T2DM.

Download Full-text