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

L. Munch; B. B. Bennich; D. Overgaard; H. Konradsen; H. Middelfart; N. Kaarsberg; F. K. Knop; T. Vilsbøll; M. E. Røder

doi:10.1111/dme.13896

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

L. Munch, B. B. Bennich, D. Overgaard, H. Konradsen, H. Middelfart, N. Kaarsberg, F. K. Knop, T. Vilsbøll, M. E. Røder^*

^*Corresponding author for this work

Department of Clinical Medicine

4 Citations (Scopus)

Abstract

Aim: To evaluate whether management of people with Type 2 diabetes shared between a specialized outpatient clinic and primary health care has noninferior HbA_1c 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 HbA_1c from baseline to 12 months of follow-up. The noninferiority margin for HbA_1c was 4.4 mmol/mol. Results: A total of 140 people were randomized [age 65.0 ± 0.9 years, HbA_1c 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), HbA_1c 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.

Original language	English
Journal	Diabetic Medicine
Volume	36
Issue number	7
Pages (from-to)	854-861
ISSN	0742-3071
DOIs	https://doi.org/10.1111/dme.13896
Publication status	Published - 2019

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Munch, L., Bennich, B. B., Overgaard, D., Konradsen, H., Middelfart, H., Kaarsberg, N., Knop, F. K., Vilsbøll, T., & Røder, M. E. (2019). 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. Diabetic Medicine, 36(7), 854-861. https://doi.org/10.1111/dme.13896

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. / Munch, L.; Bennich, B. B.; Overgaard, D. et al.
In: Diabetic Medicine, Vol. 36, No. 7, 2019, p. 854-861.

Research output: Contribution to journal › Journal article › Research › peer-review

Munch, L, Bennich, BB, Overgaard, D, Konradsen, H, Middelfart, H, Kaarsberg, N, Knop, FK , Vilsbøll, T & Røder, ME 2019, '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', Diabetic Medicine, vol. 36, no. 7, pp. 854-861. https://doi.org/10.1111/dme.13896

@article{fb86a0387e7846238db15071082a9bae,

title = "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",

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.",

author = "L. Munch and Bennich, {B. B.} and D. Overgaard and H. Konradsen and H. Middelfart and N. Kaarsberg and Knop, {F. K.} and T. Vilsb{\o}ll and R{\o}der, {M. E.}",

year = "2019",

doi = "10.1111/dme.13896",

language = "English",

volume = "36",

pages = "854--861",

journal = "Diabetic Medicine",

issn = "0742-3071",

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TY - JOUR

T1 - 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

T2 - a randomized, noninferiority trial

AU - Munch, L.

AU - Bennich, B. B.

AU - Overgaard, D.

AU - Konradsen, H.

AU - Middelfart, H.

AU - Kaarsberg, N.

AU - Knop, F. K.

AU - Vilsbøll, T.

AU - Røder, M. E.

PY - 2019

Y1 - 2019

N2 - 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.

AB - 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.

U2 - 10.1111/dme.13896

DO - 10.1111/dme.13896

M3 - Journal article

C2 - 30614066

AN - SCOPUS:85060729076

SN - 0742-3071

VL - 36

SP - 854

EP - 861

JO - Diabetic Medicine

JF - Diabetic Medicine

IS - 7

ER -