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Rapid Responses: Rapid Responses published:
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State of the Art
- Regina Stroebele (6 November 1999)
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Twice daily versus four times daily insulin dose regime for diabetics in pregnancy
- Prabirkumar Bandyopadhyay (18 November 1999)
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Faulty conclusions from study of conventional and intensive glucose control in pregnancy
- Roy Taylor (23 November 1999)
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Treatment of diabetes in pregnancy
- Emma Poyner (25 November 1999)
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Regina Stroebele, GP (Ghostwriting Practioner) unemployed
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..is continuous administration of insuline subcutaneously by a small pump - plus survey by a specialised department - at least for pregnant German women with IQ over 99. |
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Prabirkumar Bandyopadhyay
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Editor- We read with interest the article by Nachum et al 1 and we think some points regarding this insulin regime deserve comment. Veciana M et al found that adjustment of insulin therapy using twice daily insulin dose regimen in women with gestational diabetes according to the result of the I hour post prandial blood glucose levels improved glycaemic control and decreased the risk of neonatal hypoglycaemia, macrosomia and Caesarean delivery2. The incidences of macrosomia and large for gestational age were lower in this study compared to the study by Nachum et al (9% vs 16% and 12% vs 26% respectively). The other end points being comparable doubt arises about the compliance of two more injections daily throughout pregnancy. Human Insulin (HI) is immunogenic and a short course of HI therapy induces insulin antibody (IA) in about 50% of women with gestational diabetes and 92% Type 1 Diabetic patients3. Menon and colleagues reported that placental transfer of insulin complexed with immunoglobulin was associated with foetal macrosomia in mothers with near normal glycaemic control during gestation4. In this study the antibody bound insulin transferred to the foetus was proportional to the concentration of antibody bound insulin increased in the mother. But if HI is used in higher doses as done by Nachum et al1, the titre of IA will also be high and consequently the percentage of insulin binding will be more and associated adverse effects including macrosomia might increase. If these IA remained positive the patients would be theoretically at risk of developing insulin allergy or insulin resistance in case the reintroduction of insulin is required. The insulin lispro improves post prandial glucose control (which is important for managing gestational diabetes), reduces hypoglycaemic episodes and improves patient convenience compared with regular human insulin. The duration of action of insulin lispro is shorter than regular human insulin explaining its decreased immunogenicity and reduced placental transfer. On the contrary regular Human insulin activity can significantly overlap with basal insulin activity between meals and especially at night causing excessive glucose excursions and hypoglycaemia3. Foetal pancreatic B cell development may be enhanced by minimal elevations in plasma glucose and other fuels particularly insulinogenic aminoacids. The ensuing foetal hyperinsulinaemia together with excess nutrient supply may enhance foetal growth even if glycaemic control is satisfactory in late gestation5. In view of the above findings the maternal plasma aminoacid concentration, the insulin antibody status in maternal serum and placental transfer of insulin complexed with immunoglobulin would be quite useful as they are well recognised causes of foetal macrosomia and large for gestation infants. Moreover insulin lispro might be a better choice in managing women with gestational diabetes because of its added advantages mentioned earlier. Thanking You Yours truly Dr Prabirkumar Bandyopadhyay
Dr Saumitra Baksi
St Mary's Hospital, Newport, Isle of Wight PO30 5TG References 1 Nachum Z, Ben-Shlomo I, Weiner E, Shalev E. Twice daily versus four times daily insulin dose regimens for diabetes in pregnancy: randomised control trial. BMJ 1999; 319: 1223-7 2 Veciana M, Major CA, Morgan MA, Asrat T, Toohey JS, Lien JM et al. Post prandial versus preprandial blood glucose monitoring in women with gestational diabetes requiring insulin therapy. N Engl J Med 1995; 333: 1237-41 3 Balsells M, Corcoy R, Mauricio D, Morales J, Garcia- Patterson A, Carreras G et al. Insulin antibody response to a short course of human insulin therapy in women with gestational diabetes. Diabetes Care 1997; 20: 1172-75 4 Menon RK, Cohen RM, Sperling MA, Cutfield WS, Mimouni F, Khoury JC. Transplacental passage of insulin in pregnant women with Insulin dependant diabetes mellitus: its role in foetal macrosomia. N Engl J Med 1990; 323: 309-15 5 Butte NF, Hsu HW, Thotathuchery M, Wong WW, Khoury J, Reeds P. Protein metabolism in insulin treated gestational diabetes. Diabetes Care 1999; 22: 806-11 |
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Roy Taylor, Professor of Medicine and Metabolism RVI, Newcastle upon Tyne
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Response to Nachum et al BMJ 6.11.99 Nachum and colleagues draw conclusions from their open study of management of diabetes in pregnancy which are not justified by their data. Firstly, They claim that the number of insulin injections per day explains an apparently lower rate of neonatal morbidity. Previous work has clearly demonstrated the importance of overall clinical approach and intensity of diabetes care provided rather than the method of insulin administration (1). In young people the change to a four times daily insulin regimen is associated with an average deterioration of blood glucose control (2). It is clearly the case that each person with diabetes should be managed in the best and most practical manner for that individual. The number of injections is but one consideration. Nachum and colleagues do not draw attention to the considerable difference in average insulin dose between the two groups (120 vs. 92 units per day in pre-existing diabetes group and 65 vs. 43 units per day in the gestational diabetes group). Surely the two groups should be labelled "intensive management" and "conventional management"? Secondly, the observation that neonatal hypoglycaemia rates were lower in the intensively managed groups requires careful consideration. The authors assume that the minimally better average blood glucose control during pregnancy brought about the difference. However, in groups of women with good control during pregnancy there is no relation between degree of control and risk of neonatal hypoglycaemia but rather there is a clear relationship with blood glucose levels during the final stages of labour (3). Can Nachum and colleagues provide information on control during labour? What were the characteristics of those women whose babies had hypoglycaemia, and specifically what was the HbA1c during pregnancy leading to neonatal hypoglycaemia compared to the rest? As the study reported is large and prospective, answers to the above questions will be important in allowing proper interpretation. References 1. Marshall SM, Home PD, Taylor R, Alberti KDMM. Continuous subcutaneous insulin infusion compared with injection therapy: A randomised cross-over trial under usual diabetic clinic conditions. Diabet Med 1987;4:521-5. 2. Mortensen HB, Villumsen J, Volund A, Petersen KE, Nerup J. The relationship between insulin injection regimen and metabolic control in young Danish type I diabetic patients. Diabet Med 1992;9:834-9. 3. Carron-Brown S, Kyne-Grzebalski D, Mwangi B, Taylor R. Effect of managemnt policy upon 120 type 1 diabetic pregnancies: policy decisions in practice. Diabet Med 1999;16:573-8. Roy Taylor
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Emma Poyner, medical student University of Newcastle
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Dear Sir In the randomised control trial of diabetic treatment in pregnant women with diabetes, Nachem et al1, achieved better glycaemic control with a four times daily regimen when compared with a standard two times daily regimen. We have some concerns about the methods and analysis. The authors compared baseline data between the two groups. Glycaemic control was measured using Fructosamine, Capillary whole blood glucose and HbA1c. We feel they could improve the study by stating baseline control in the pregestational group. This would have demonstrated that the two groups were comparable and the previous diabetic control had not influenced the results. We noted that the two groups were given different methods of insulin administration. The four times daily regimen used pens, whilst the twice daily used injections. Therefore we question, was the improvement in control due to better compliance2 rather than the regimen used? Another potential source of bias was the non-blind nature of the study. We note the higher levels of insulin in the four times daily group. This may reflect more aggressive monitoring and treatment by clinicians. Blinding of the clinicians, whilst difficult to achieve, would have ensured the same treatment for both groups. Yours sincerely Shikha Chattree
3rd Year Medical Students
References: (1) Nachum Z, Ben-Shlomo I, Weiner E, Shalev E. Twice daily versus four times daily insulin dose regimens for diabetes in pregnancy: randomised controlled trial. BMJ.1999;319:1223-1227 (2) Dunbar JM, Madden PM, Gleeson DT, Fiad TM, McKenna TJ. Premixed insulin preparations in pen syringes maintain glycemic control and are preferred by patients. Diabetes Care 1994;17:874-8 Words 197 |
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