The Efficacy And Safety Of The Short-term Application Of Sensor-augmented Insulin-pump In Patients With Type1Diabetes Mellitus

Objective: To investigate the efficacy and safety of the short-term application ofsensor-augmented insulin-pump in patients with type1diabetes mellitus (T1DM).Methods：27patients with T1DM, aged between10and59years, HbA1c＞7.0%，were enrolled. The sensor-augmented insulin-pumps were attached for72hours sincethe second day of hospitalization. Set high and low blood s glucose alarm,when a alarmadjust CSII infusion in time.Fingertip blood glucose level was measured4times per day(before each meal and at bedtime). The blood glucose values were entered into thepump under the guidance of the medical staff. The dose of insulin was adjusted,according to the data downloaded at8:00in the morning. Immunonephelometry wasused to measure serum C-reactive protein levels. The means and standard deviations ofblood glucose, the area under curve (AUC) of hyperglycemia, the frequency ofhypoglycemic events and mean daily dose of insulin on the first day and on the thirdday of pump therapy, were compared. After discharge, we conducted telephonefollow-up every two weeks and clinic visit follow-up every month, in order to optimizeglucose control. After3months, blood fasting plasma glucose (FPG), glycatedhemoglobin A1c (HbA1c), fasting C-peptide (FCP), postprandial C-peptide at2hoursloading a steamed bread meal and C-reactive protein were tested in outpatient clinicfollow-up. The changes of the above variables were compared. Results:1.27patients were attached with the sensor-augmented insulin-pumpduring hospitalization,14males,13females, age10~59years, course0.5~15years,HbA1c10.94±2.55%.12patients continued outpatient follow-up3months later andcompleted the questionnaires.2. The27patients were stratified into two groups according to the duration ofT1DM. In the two groups, the mean and standard deviation of blood glucose, thehyperglycemia AUC were significantly decreased on the third day of pump therapywhen compared with those on the first day (P<0.05). In the two groups, other variablesdid not show significant differences on the first day and the third day of pump therapy.3. The27patients were stratified into two groups according to the level of HbA1c(median11.0%). In patients with low HbA1c, the mean and standard deviation of bloodglucose, the hyperglycemia AUC, the occurrence of hypoglycemic events weresignificantly decreased on the third day of pump therapy than those on the first day(P<0.05). In patients with high HbA1c, the mean and standard deviation of bloodglucose, the hyperglycemia AUC, the occurrence of hypoglycemic events weresignificantly decreased on the third day of pump therapy than those on the first day(P<0.05). On the first day of pump therapy, CRP and mean daily dose of insulin weresignificantly higher in patients with high HbA1c than those in patients with low HbA1c(P<0.05). FCP was significantly lower in patients with high HbA1c than that in patientswith low HbA1c (P<0.05). On the third day of pump therapy, mean blood glucose andthe daily dose of insulin were significantly higher in patients with high HbA1c thanthose in patients with low HbA1c (P<0.05).4. The27patients were stratified into two groups according to FCP (median0.27ng/ml). In the low FCP group, the mean and standard deviation of blood glucose,and the hyperglycemia AUC were significantly decreased on the third day of pumptherapy than those on the first day (P<0.05). In the high FCP group, the mean andstandard deviation of blood glucose, and the hyperglycemia AUC were significantlydecreased on the third day of pump therapy than those on the first day (P<0.05). On thefirst day of pump therapy, CRP, the mean and standard deviation of blood glucose, the hyperglycemia AUC, and daily dose of insulin were significantly higher in low FCPgroup than those in high FCP group (P<0.05). In addition,2hCP in high FCP group wassignificantly higher than that in low FCP group (P<0.05). On the third day of pumptherapy, the standard deviation of blood glucose, the hyperglycemia AUC, and meandaily dose of insulin in low FCP group were significantly higher than those in high FCPgroup (P<0.05).5. The linear correlation analysis of mean blood glucose, the standard deviation ofblood glucose and high blood glucose area under curve of the27patients.Mean bloodglucose was positively associated with HbA1c (r=0.623, P<0.01) the hyperglycemiaAUC (r=0.994, P<0.01), mean daily dose of insulin (r=0.659, P<0.01) and CRP(r=0.434, P<0.05). It was negatively associated with FCP and2h CP (r=-0.442,-0.482,respectively, P<0.05). The standard deviation of blood glucose was positivelyassociated with mean daily dose of insulin (r=0.454, P＜0.05) and CRP (r=0.442,P<0.05). It was negatively associated with FCP (r=-0.499, P<0.01) and2hCP (r=-0.520, P<0.01).The hyperglycemia AUC was positively associated with HbA1c(r=0.614, P＜0.01), mean blood glucose (r=0.994, P<0.01) and mean daily dose ofinsulin (r=0.632, P＜0.01). It was negatively associated with FCP (r=-0.426, P<0.05)and2hCP (r=-0.449, P<0.05).6. The data of the12patients who completed the follow-up, showed decreasedHbA1c and FPG after3months (P<0.05). FCP and2hCP seemed increased with nostatistical significance.7. The12patients who completed the follow-up after3months: When stratifiedinto two groups according to the duration of T1DM (median4.0years),the decrease ofCRP was greater in patients with longer duration of T1DM than that in patients withshorter duration (P<0.05). When stratified into two groups according to HbA1c (median11.5%),In high HbA1c group, FPG significantly decreased after3months(P<0.05).When stratified into two groups according to FCP (median0.26mg/ml),In thehigh FCP group, FPG significantly decreased after3months (P<0.05). Conclusion:1. The short term application of sensor-augmented insulin-pump cansignificantly lower blood glucose levels and reduce the amplitude of glycemicexcursions in patients with T1DM. It is safe as the frequency of hypoglycemia is notincreased. And the patients have a long-term benefit.2. The levels blood glucose and amplitude of glycemic excursions, as well as theoccurrence of hypoglycemia in patients with a short-term attachment of insulin pumpwere not associated with the duration of T1DM.3. In patients with T1DM, great HbA1c levels indicates severe inflammation.4. In patients with T1DM, the worse function of pancreatic islet, is associated withhigher blood glucose levels and the amplitude of glycemic excursions, and more severethe inflammation.