MANAGEMENT OF DIABETES MELLITUS DURING THE HOLY MONTH OF RAMADAN

PREVENTION OF HYPOGLYCAEMIA

DURING RAMADAN IN INSULINwTREATED PATIENTS

RESULTS FROM A MULTICENTKE STUDY: 2 Javed Akram

Akram Medical Complex 2-B, Main Gulberg, Lahore, Pakistan

Figure. Severity of hypoglycaemic episodes, with regular and lispro insulins

30 ,

Mild Moderate

INTRODUCTION Hypoglycaemia remains one of the most feared complications of insulin therapy, carrying a risk of morbidity and mortality. Hypoglycaemia gains much more import- ance during Ramadan fasting because, during the fasting state, one is forbidden to take any medications, either oral or parent- eral, in addition to total abstinence from any food or drink. Thus hypoglycaemia is not only feared to be precipitated by fasting but the treatment of hypoglycaemia will obviously result in abolition of the fast.

During Ramadan fasting, a bolus insulin which could be given immediately prior to meals would be preferable since patients wish to eat as early after sunset as possible. Also it should be short acting in order to avoid late hypoglycaemic episodes after sunrise. The rationale for the use of insulin lispro during Ramadan fasting was pro- vided from a number of recent comparative studies of insulin lispro with regular human insulin which consistently showed superi- ority of lispro in avoiding hypoglycaemic episodes without adverse effects on metabolic control.

The objectives of the study under consideration were to compare insulin lispro with regular human insulin in patients with Type 2 diabetes fasting

during Ramadan. Measurements examined included metabolic parameters, rate and severity of hypoglycaemic episodes and quality of life, and this paper describes the results for hypoglycaemia.

PATIENTS AND METHODS This was a randomised, open-label, comparative study in patients who received insulin lispro and regular human insulin during Ramadan in a cross-over design described more fully in the previous paper'. Metabolic parameters were assessed by measuring fasting and post-prandial blood glucose levels from home blood glucose monitoring during each therapy period. Hypoglycaemic episodes were defined as symptomatic or from blood glucose level less than 3.0mmoM.

RESULTS A total of 25/56 (44.6%) patients experienced hypoglycaemic episodes during the study. The number of patients with hypoglycaemic episodes were similar for both treatment sequence periods. However, when sequence periods were combined by treatment, the patients had hypoglycaemic episodes more frequently during treatment with regular insulin than during treatment with insulin lispro. Mean

hypoglycaemic episodes per patient per 14 days were 1.3 f 0.7 versus 2.6 A 1.4 (p=0.002) for insulin lispro and regular human insulin respectively. There was a total of 73 hypoglycaemic episodes during the study, of which 22 (30.1%) were during insulin lispro treatment compared with 51 (69.9%) during regular insulin treatment. Both mild and moderate episodes (Figure) were significantly (p<O.Ol) less during insulin lispro treatment. The majority of the episodes occurred during the time period from 6 hours after the sunrise meal (Sehar) until the break of the fast at sunset (Iftar). During regular insulin therapy, 64% of hypoglycaemic symptoms were classified as autonomic and 36% as neuroglycopenic. During insulin lispro the symptoms were 46% autonomic and 56% neuroglycopenic but the treatment differences were not significant. No episodes of severe hypogly- caemia were reported during the study period.

DISCUSSION The conclusion from this study was that it is safe for patients with stable Type 2 diabetes to fast on twice daily regimens of short-acting insulin injections along with intermediate acting insulin as basal therapy. Among the short acting insulins, the study showed that therapy with insulin lispro was superior to therapy with regular human insulin regarding the frequency and severity of hypoglycaemias, control of post-prandial hyperglycaemia and patient convenience.

Reference 1. El-Ghazali S. Control of post-prandial

blood glucose with insulin treatment during ramadan: results of a multicenter study. Practical Diabetes Int 1998; S18.

Practical Diabetes International Supplement January/February 1998 Vol. 15 No. I S19