Evaluating The Safety And Efficacy About The Different Injection Time Of Insulin Glargine In Patients With Type 1 Diabetes.

Diabetes is a chronic disease which seriously affects human healthy, the rate of which is rising year by year .the acute and chronic complications caused by diabetes seriously reduce patients' qualities of lives and impose heavy burden on the patients themselves, their families and society. Type 1 diabetes accounts for about 5% [1] of all types of diabetes. Compared with type 2 diabetes, the patients with type 1 diabetes have an early onset age with acute, obvious and serious symptoms .Most of their islet cell antibodies are positive. They are sensitive to insulin and their blood glucose is much more fluctuating and unstable. Because patients with type 1 diabetes can't secret enough insulin absolutely, they need long-term insulin treatment. Since insulin glargine came into the market, its long duration of action, low incidence of hypoglycemia make it widely use in clinics. At the beginning of the listing process, some of the studies found that insulin glargine was stable and had no peaks compared with NPH. So it could be used at any time during the day. But in clinical observation we found that some patients with type 1 diabetes could have better fast blood glucose, lower hypoglycemia episodes before lunch, lower high blood glucose episodes after hypoglycemia and smaller blood glucose fluctuations without changing the doses of insulin glargine after changing the injection time of insulin glargine from 22:00 to 18:00.This article recorded the differences in the data of blood glucose and the doses of insulin for 3 days before and after changing the injection time. We observe the safety and efficacy about the different injection time of insulin glargine. According to the relationship between the change of blood glucose and the different injection time, we want to deduce if insulin glargine has a peak and when the peak is.Objective: to evaluate the safety and efficacy about the different injection time of insulin glargine in patients with type 1 diabetes.Methods: We collected clinical data and information of 36 type 1 diabetic patients who changed subcutaneous injection time of insulin glargine from 22:00 to 18:00 from January 2005 to March 2011 in the department of endocrine of our hospital. We compared the fast blood glucose, the blood glucose before lunch, postprandial blood glucose, the doses of regular insulin or insulin aspart and insulin glargine during the 3 days before and after changing the injection time. All the patients enrolled were divided into two groups according to the different insulin. One group used insulin glargine in combination with regular insulin; the other group used insulin glargine in combination with insulin aspart. There were 12 participants in the insulin glargine in combination with regular insulin group, including 5 men and 7 women( average age:31.92±13.83 years, duration of diabetes:95.50±80.50 months, HbA1c :10.89%±3.65, average BMI :21.63±3.36).there were 24 participants in the insulin glargine in combination with insulin aspart group, including 15 men and 9 women,(average age :30.88±11.30 years, Duration of diabetes:57.63±51.13months, HbA1c :10.39%±2.90, average BMI:20.55±2.75).During hospitalization,doctors calculated diabetic recipes according to the patients'height, weight, renal function, amount of exercise of the patients. The hospital department of nutrition and the nutrition restaurant made the diabetic meals which were fit for every special patient. Patients had dinner strictly in accordance with diabetic recipes. All of the patients enrolled were older than 6 years old without tumor or family histories of cancers. During the observation period, Patients had fixed meal time and amount of exercise every day. They did not have acute stress, liver or kidney dysfunction; they did not abuse alcohol or have drugs that affect blood glucose. Similar to Julio Rosenstock's experiment[2], confirmed or documented hypoglycemia was defined as plasma glucose levels≤3.9mmol/l,≤2.8mmol/l, or≤2.0mmol/l.Results:After changing the injection time of insulin glargine from 22:00 to 18:00, in the group that used the insulin glargine in combination with regular insulin fast blood glucose decreased, moderate hypoglycemia episodes (Blood glucose≤2.8mmol/l) before lunch decreased, the blood glucose before lunch reached a more ideal level, post lunch blood glucose decreased. The differences above had statistically significance (p<0.05). The number of hypoglycemia episodes (Blood glucose≤3.9mmol/l) before lunch decreased, but the change did not have statistically significance(p>0.05).After changing the injection time of insulin glargine to 18:00, in the group that used insulin glargine in combination with insulin aspart, fast blood glucose decreased ,the blood glucose before lunch increased from a lower level to a more ideal level ,The differences above had obvious statistically significance (p<0.01). Post lunch blood glucose and hypoglycemia episodes (Blood glucose≤3.9mmol/l) before lunch and moderate hypoglycemia episodes (Blood glucose≤2.8mmol/l) before lunch decreased ,the changes had statistically significance (p<0.05).No matter in the group that used the insulin glargine in combination with regular insulin or the group that used the insulin glargine in combination with insulin aspart, there was no statistically significance of post breakfast blood glucose, post supper blood glucose, the doses of regular insulin or insulin aspart or insulin glargine after changing the injection time(p>0.05). During the observation period, there was no blood glucose less than 2.0mmol/l happened in the two groups.Conclusions:For type 1 diabetes, we can decrease the fast blood glucose and the rate of hypoglycemia before lunch by changing the injection time from 22:00 to 18:00 without increasing the doses of insulin glargine .this result suggests that insulin glargine has a little peak at 12-13 hours after subcutaneous injection. Using the character of insulin glargine , for type 1 diabetes we can reduce the occurrence of hypoglycaemia and the fluctuation of blood glucose by changing the injection time of insulin glargine from 22:00 to 18:00 without increasing the doses of insulin, so we can achieve blood glucose control goal easily and conveniently.