Skip to main content
Top
Published in: Diabetologia 6/2008

01-06-2008 | For Debate

N of 1 trials in diabetes: making individual therapeutic decisions

Authors: A. Tsapas, D. R. Matthews

Published in: Diabetologia | Issue 6/2008

Login to get access

Abstract

N of 1 trials are single-subject, randomised, crossover studies, in which the patient serves as their own control to compare the efficacy of a treatment. They offer an alternative to large, randomised clinical trials, which have limited applicability, and empirical testing, which is arbitrary in nature. N of 1 trials are regarded as providing the highest strength of evidence for individual subject decisions. They rely upon the patient expressing preferences and making shared decisions for determining the future therapy, and may therefore lead to the successful implementation of lifestyle interventions. N of 1 trials are an optimal approach for making therapeutic decisions in chronic diseases like diabetes mellitus, where decision-making is often reliant upon arbitrary criteria and clinical judgement.
Literature
1.
go back to reference The Diabetes Control and Complications Trial Research Group (1993) The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329:977–986CrossRef The Diabetes Control and Complications Trial Research Group (1993) The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329:977–986CrossRef
2.
go back to reference The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group (2003) Intensive diabetes therapy and carotid intima–media thickness in type 1 diabetes mellitus. N Engl J Med 348:2294–2303CrossRef The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group (2003) Intensive diabetes therapy and carotid intima–media thickness in type 1 diabetes mellitus. N Engl J Med 348:2294–2303CrossRef
3.
go back to reference Stratton IM, Adler AI, Neil HA et al (2000) Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 321:405–412PubMedCrossRef Stratton IM, Adler AI, Neil HA et al (2000) Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 321:405–412PubMedCrossRef
4.
go back to reference American Diabetes Association (2008) Standards of medical care in diabetes—2008. Diabetes Care 31:S12–S54CrossRef American Diabetes Association (2008) Standards of medical care in diabetes—2008. Diabetes Care 31:S12–S54CrossRef
5.
go back to reference Nathan DM, Buse JB, Davidson MB et al (2006) Management of hyperglycaemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 49:1711–1721PubMedCrossRef Nathan DM, Buse JB, Davidson MB et al (2006) Management of hyperglycaemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 49:1711–1721PubMedCrossRef
6.
go back to reference The Diabetes Control and Complications Trial Research Group (1997) Hypoglycemia in the diabetes control and complications trial. Diabetes 46:271–286CrossRef The Diabetes Control and Complications Trial Research Group (1997) Hypoglycemia in the diabetes control and complications trial. Diabetes 46:271–286CrossRef
8.
go back to reference Anderson RM, Robins LS (1998) How do we know? Reflections on qualitative research in diabetes. Diabetes Care 21:1387–1388PubMedCrossRef Anderson RM, Robins LS (1998) How do we know? Reflections on qualitative research in diabetes. Diabetes Care 21:1387–1388PubMedCrossRef
9.
go back to reference Daar AS, Singer PA, Persad DL et al (2007) Grand challenges in chronic non-communicable diseases. Nature 450:494–496PubMedCrossRef Daar AS, Singer PA, Persad DL et al (2007) Grand challenges in chronic non-communicable diseases. Nature 450:494–496PubMedCrossRef
10.
go back to reference Goldberg RB, Holman R, Drucker DJ (2008) Clinical decisions. Management of type 2 diabetes. N Engl J Med 358:293–297PubMedCrossRef Goldberg RB, Holman R, Drucker DJ (2008) Clinical decisions. Management of type 2 diabetes. N Engl J Med 358:293–297PubMedCrossRef
11.
go back to reference Halperin F, Ingelfinger JR, McMahon GT (2008) Clinical decisions. Management of type 2 diabetes—polling results. N Engl J Med 358:e8 Halperin F, Ingelfinger JR, McMahon GT (2008) Clinical decisions. Management of type 2 diabetes—polling results. N Engl J Med 358:e8
12.
go back to reference Gaede P, Lund-Andersen H, Parving H-H, Pedersen O (2008) Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med 358:580–591PubMedCrossRef Gaede P, Lund-Andersen H, Parving H-H, Pedersen O (2008) Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med 358:580–591PubMedCrossRef
13.
go back to reference Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS (1996) Evidence based medicine: what it is and what it isn’t. BMJ 312:71–72PubMed Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS (1996) Evidence based medicine: what it is and what it isn’t. BMJ 312:71–72PubMed
14.
go back to reference Guyatt GH, Haynes RB, Jaeschke RZ et al (2000) Users’ guides to the medical literature: XXV. Evidence-based medicine: principles for applying the users’ guides to patient care. JAMA 284:1290–1296PubMedCrossRef Guyatt GH, Haynes RB, Jaeschke RZ et al (2000) Users’ guides to the medical literature: XXV. Evidence-based medicine: principles for applying the users’ guides to patient care. JAMA 284:1290–1296PubMedCrossRef
15.
go back to reference Nikles CJ, Clavarino AM, Del Mar CB (2005) Using n-of-1 trials as a clinical tool to improve prescribing. Br J Gen Pract 55:175–180PubMed Nikles CJ, Clavarino AM, Del Mar CB (2005) Using n-of-1 trials as a clinical tool to improve prescribing. Br J Gen Pract 55:175–180PubMed
16.
go back to reference Guyatt G, Sackett D, Adachi J et al (1988) A clinician’s guide for conducting randomized trials in individual patients. CMAJ 139:497–503PubMed Guyatt G, Sackett D, Adachi J et al (1988) A clinician’s guide for conducting randomized trials in individual patients. CMAJ 139:497–503PubMed
17.
go back to reference Sackett DL, Havnes RB, Guyatt SH, Tugwell P (1991) Clinical epidemiology: a basic science for clinical medicine. Little, Brown & Co., Boston Sackett DL, Havnes RB, Guyatt SH, Tugwell P (1991) Clinical epidemiology: a basic science for clinical medicine. Little, Brown & Co., Boston
18.
go back to reference Brookes ST, Biddle L, Paterson C, Woolhead G, Dieppe P (2007) “Me’s me and you’s you” Exploring patients’ perspectives of single patient (n-of-1) trials in the UK. Trials 8:10PubMedCrossRef Brookes ST, Biddle L, Paterson C, Woolhead G, Dieppe P (2007) “Me’s me and you’s you” Exploring patients’ perspectives of single patient (n-of-1) trials in the UK. Trials 8:10PubMedCrossRef
21.
go back to reference Avins AL, Bent S, Neuhaus JM (2005) Use of an embedded N-of-1 trial to improve adherence and increase information from a clinical study. Contemp Clin Trials 26:397–401PubMedCrossRef Avins AL, Bent S, Neuhaus JM (2005) Use of an embedded N-of-1 trial to improve adherence and increase information from a clinical study. Contemp Clin Trials 26:397–401PubMedCrossRef
22.
go back to reference Golin CE, DiMatteo MR, Gelberg L (1996) The role of patient participation in the doctor visit. Implications for adherence to diabetes care. Diabetes Care 19:1153–1164PubMedCrossRef Golin CE, DiMatteo MR, Gelberg L (1996) The role of patient participation in the doctor visit. Implications for adherence to diabetes care. Diabetes Care 19:1153–1164PubMedCrossRef
23.
go back to reference Brody DS, Miller SM, Lerman CE, Smith DG, Caputo GC (1989) Patient perception of involvement in medical care: relationship to illness attitudes and outcomes. J Gen Intern Med 4:506–511PubMedCrossRef Brody DS, Miller SM, Lerman CE, Smith DG, Caputo GC (1989) Patient perception of involvement in medical care: relationship to illness attitudes and outcomes. J Gen Intern Med 4:506–511PubMedCrossRef
24.
go back to reference Ong LM, de Haes JC, Hoos AM, Lammes FB (1995) Doctor–patient communication: a review of the literature. Soc Sci Med 40:903–918PubMedCrossRef Ong LM, de Haes JC, Hoos AM, Lammes FB (1995) Doctor–patient communication: a review of the literature. Soc Sci Med 40:903–918PubMedCrossRef
25.
go back to reference Stewart MA (1995) Effective physician–patient communication and health outcomes: a review. CMAJ 152:1423–1433PubMed Stewart MA (1995) Effective physician–patient communication and health outcomes: a review. CMAJ 152:1423–1433PubMed
26.
go back to reference Hoogwerf BJ (1985) Amitriptyline treatment of painful diabetic neuropathy: an inadvertent single-patient clinical trial. Diabetes Care 8:526–527PubMed Hoogwerf BJ (1985) Amitriptyline treatment of painful diabetic neuropathy: an inadvertent single-patient clinical trial. Diabetes Care 8:526–527PubMed
Metadata
Title
N of 1 trials in diabetes: making individual therapeutic decisions
Authors
A. Tsapas
D. R. Matthews
Publication date
01-06-2008
Publisher
Springer-Verlag
Published in
Diabetologia / Issue 6/2008
Print ISSN: 0012-186X
Electronic ISSN: 1432-0428
DOI
https://doi.org/10.1007/s00125-008-0983-2

Other articles of this Issue 6/2008

Diabetologia 6/2008 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.