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
Hayden Ellis
Emma Poyner
Jonathan Smith
Anna Zoltowski
3rd Year Medical Students
Department of Epidemiology & Public Health,
University of Newcastle
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
Rapid Response:
Treatment of diabetes in pregnancy
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
Hayden Ellis
Emma Poyner
Jonathan Smith
Anna Zoltowski
3rd Year Medical Students
Department of Epidemiology & Public Health,
University of Newcastle
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
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Competing interests: No competing interests