Intensive attention improves glycaemic control in insulin-dependent diabetes without further advantage from home blood glucose monitoring: results of a controlled trial.

Worth, Richard; Home, Philip; Johnston, Desmond G.; Anderson, J.; Ashworth, L.; Burrin, Jacky M.; Appleton, D. J.; Binder, Chr.; Alberti, K. G. M. M.

doi:10.1136/bmj.285.6350.1233

Cited by 137 publications

(75 citation statements)

References 41 publications

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“…When this technique was introduced, it was assumed that patients who monitor their blood would achieve better control than those who tested their urine. Contrary to expectation, a controlled trial showed that patients randomized to blood or urine tests did equally well when equal time and attention was provided by their health care providers (14).…”

Section: Discussionmentioning

confidence: 66%

Recruitment to a Clinical Trial Improves Glycemic Control in Patients With Diabetes

Gale

Beattie

et al. 2007

Diabetes Care

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OBJECTIVE -We assessed the effect upon A1C of recruitment to a clinical trial in patients with diabetes who had been screened and interviewed to determine eligibility but whose therapy was otherwise unchanged.RESEARCH DESIGN AND METHODS -Eligible trials were selected from the global program of an insulin manufacturer. Included were studies in which patients were seen on a single screening visit, pharmaceutical therapy was not altered before randomization, and A1C was measured in a central laboratory at both screening and randomization. Three trials involving patients with type 1 diabetes (n ϭ 429) and three trials involving patients with type 2 diabetes (n ϭ 611) were identified for analysis. The main outcome measure was change in A1C. Separate regression equations on the change in A1C were fitted for type 1 and type 2 diabetes and included effects of baseline A1C and the interval between the screening and randomization visits.RESULTS -A1C changed by Ϫ0.13% (range ϩ0.09 to Ϫ0.26%) in those with type 1 diabetes at a median of 28 days and by Ϫ0.16% (Ϫ0.14 to Ϫ0.27%) for those with type 2 diabetes at a median of 14 days. The mean change in A1C in those with an interval of Ն28 days was Ϫ0.24% for those with type 1 diabetes and Ϫ0.23% for those with type 2 diabetes. The reduction was proportional to initial A1C, with large decreases in those with the poorest initial control but no overall change in those at or below the 10th percentile of A1C.CONCLUSIONS -Recruitment to a clinical trial, independent of any therapeutic intervention, produces improvements in glucose control. Diabetes Care 30:2989-2992, 2007D iabetes management centers on the patient, who assumes direct responsibility for all aspects of his or her care. This includes day-to-day management of finger-stick glucose measurements, diet, exercise, and glucoselowering medications (oral tablets and/or insulin injections). Successful integration of these variables is demanding and requires unremitting attention. Behavioral interventions have been shown to improve glucose control (1), but it is not easy to distinguish between the specific benefit of such interventions and the nonspecific effects of study participation, which include increased patient attention and motivation. There is some evidence that patients' glycemic control will benefit simply from participation in a clinical study (2).We wanted to estimate the influence of study participation on glucose control by retrospective analysis of the effect of the single screening visit that precedes allocation to treatment in a clinical trial. Patients potentially eligible for such trials meet a study representative, usually the study nurse. In the course of this visit, the nature of the study is explained, written consent to participation is obtained, and baseline clinical and laboratory measurements are made. Advice about aspects of management, such as blood glucose monitoring, may also be offered. No other intervention was offered in the trials we considered. Eligibility having been confirmed, the patient is ...

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Section: Discussionmentioning

confidence: 66%

Recruitment to a Clinical Trial Improves Glycemic Control in Patients With Diabetes

Gale

Beattie

et al. 2007

Diabetes Care

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“…A capacidade da monitorização sangüínea em proporcionar melhores índices glicêmicos foi demonstrada em muitos estudos (10,12,14) Entretanto alguns trabalhos salientam que o bom controle metabólico é independente do tipo ou freqüência da monitorização domiciliar e que, ao longo do tempo, as melhoras obtidas nos níveis glicêmicos com qualquer tipo de monitorização, tendem a se deteriorar se não houver acompanhamento, atenção intensiva e envolvimento da equipe com os o pacientes (27,36,37,38) Estudos mais recentes salientam a necessidade de intensificação da monitorização sangüínea, de forma que o perfil glicêmico seja mais sensível as flutuações glicêmicas diárias e permita maior exatidão dos ajustes terapêuticos (14,17,20,29) Quando esta intensificação atinge o número de 4 vezes ao dia e os resultados são utilizados para o ajuste diário nas múltiplas doses de insulina o controle metabólico é seguramente otimizado (18,20) . A tentativa de melhorar o controle metabólico dos pacientes no nosso serviço por meio do incentivo à monitorização sangüínea 1 vez ao dia foi bem sucedida no momento anterior a este estudo.…”

Section: -Média Das Hba1c Antes E Após As Intervenções No Grupo a Sãunclassified

Avaliação de dois esquemas de monitorização domiciliar em pacientes com diabetes mellitus do tipo 1

Grossi

Cianciarullo

Manna³

2002

Rev. esc. enferm. USP

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“…It seems likely that the initial improvement in HbA 1 observed in both groups following recruitment was due to the fact that participation in the study was suf®cient to motivate subjects to make the changes taught previously. The bene®cial effect of being in a study has been documented in other randomised studies (Korhonen et al, 1983;McCulloch et al, 1983;Worth et al, 1982).…”

Section: Discussionmentioning

confidence: 69%

Lifestyle intervention in people with insulin-dependent diabetes mellitus (IDDM)

Mann

Lewis‐Barned

et al. 1997

Eur J Clin Nutr

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Objective: To investigate the impact of intensive lifestyle education on dietary practices, exercise and metabolic measurements in people with insulin-dependent diabetes mellitus (IDDM). Design: Sixty-one volunteer subjects with IDDM were randomised to intensive (Group 1) or standard (Group 2) education programmes for six months. During a second six month period of observation Group 1 subjects received routine surveillance for their condition and those in Group 2 were given intensive advice (phase 2). Current insulin regimens were modi®ed to optimise glycaemic control before the start of the intervention phase. Nutrient intakes, weight, blood pressure, glycated haemoglobin (HbA 1 ), plasma lipids, lipoproteins and maximal oxygen consumption (VO 2 max) were measured at the time of recruitment and at three monthly intervals during the trial and phase 2. Setting: Department of Human Nutrition at the University of Otago. Results: Glycated haemoglobin decreased signi®cantly in both groups between recruitment and randomisation, the improvement being sustained during the six months of the randomised trial and for group 1 during the six months of post trial observation. A further decrease was seen in Group 2 during the second six month period when they were given intensive advice. Comparable changes were seen with total and low density lipoprotein (LDL) cholesterol in Group 1 during the trial, but signi®cant decreases were only seen in Group 2 in association with intensive intervention (phase 2). These changes occurred in parallel with increases in intakes of carbohydrate and monounsaturated fatty acids, a reduction in intakes of total and saturated fat, and an improvement in maximum oxygen consumption. Conclusions: A lifestyle programme for people with IDDM results in modest changes in diet and exercise habits suf®cient to improve measures of glycaemic control and lipoprotein mediated risk of coronary heart disease independent of changes in insulin regime. More innovative approaches to achieve lifestyle changes are required to meet current recommendations which in turn are likely to produce even greater bene®cial changes than those observed here.

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Intensive attention improves glycaemic control in insulin-dependent diabetes without further advantage from home blood glucose monitoring: results of a controlled trial.

Cited by 137 publications

References 41 publications

Recruitment to a Clinical Trial Improves Glycemic Control in Patients With Diabetes

Recruitment to a Clinical Trial Improves Glycemic Control in Patients With Diabetes

Avaliação de dois esquemas de monitorização domiciliar em pacientes com diabetes mellitus do tipo 1

Lifestyle intervention in people with insulin-dependent diabetes mellitus (IDDM)

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