1. Management of people with Type 2 diabetes shared between a specialized outpatient clinic and primary health care is noninferior to management in a specialized outpatient clinic: a randomized, noninferiority trial.
- Author
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Munch, L., Bennich, B. B., Overgaard, D., Konradsen, H., Middelfart, H., Kaarsberg, N., Knop, F. K., Vilsbøll, T., and Røder, M. E.
- Subjects
TYPE 2 diabetes ,CLINICS ,PRIMARY health care ,PERIPHERAL neuropathy ,EVALUATION of medical care ,TREATMENT of diabetes ,OUTPATIENT services in hospitals - Abstract
Aim: To evaluate whether management of people with Type 2 diabetes shared between a specialized outpatient clinic and primary health care has noninferior HbA1c outcomes compared with mono‐sectorial management in a specialized outpatient clinic. Methods: A randomized controlled, noninferiority study. People with moderate hyperglycaemia, hypertension and/or incipient complications were eligible for the study. All participants had annual comprehensive check‐ups at the outpatient clinic. Quarterly check‐ups were conducted by general practitioners (GPs) for the shared care group and by endocrinologists at the outpatient clinic for the control group. The primary outcome was the mean difference in HbA1c from baseline to 12 months of follow‐up. The noninferiority margin for HbA1c was 4.4 mmol/mol. Results: A total of 140 people were randomized [age 65.0 ± 0.9 years, HbA1c 52 ± 0.8 mmol/mol (6.9 ± 0.1%), systolic BP 135.6 ± 1.1 mmHg; all mean ± sem]. Peripheral neuropathy was present in 68% of participants and microalbuminuria in 19%; 15% had history of a previous major cardiovascular event. Among study completers (n = 133), HbA1c increased by 2.3 mmol/mol (0.2%) in the shared care group and by 1.0 mmol/mol (0.1%) in the control group, with a between‐group difference of 1.3 mmol/mol [90% confidence interval (CI) −1.3, 3.9] (0.1%, 90% CI −0.1, 0.4). Noninferiority was confirmed in both per protocol and intention to treat analyses. Conclusion: We found that our shared care programme was noninferior to specialized outpatient management in maintaining glycaemic control in this group of people with Type 2 diabetes. Shared care should be considered for the future diabetes management of Type 2 diabetes. What's new?: Most studies on shared care models targeting people with Type 2 diabetes have multifaceted interventions and short follow‐up periods.Our shared care model consisted of one annual comprehensive check‐up at a specialized diabetes outpatient clinic, plus three quarterly consultations in general practice.We found that participants followed in the shared care programme did not have worse HbA1c outcomes compared with participants followed solely in a specialized diabetes outpatient clinic.Shared care pathways could be part of future diabetes management because people with Type 2 diabetes can benefit from the specialized diabetes team while keeping close contact with their general practitioner. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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