持续皮下胰岛素输注与多次皮下胰岛素注射在2型糖尿病围手术期血糖控制疗效观察

目的 比较2型糖尿病围手术期应用持续皮下胰岛素输注(CSII)和多次皮下胰岛素注射(MSII)的血糖控制效果.方法 将外科疾病合并2型糖尿病患者180例随机分为2组,98例为CSII组(持续皮下胰岛素输注诺和灵R),82例为MSII组(多次皮下注射诺和灵R和诺和灵N,所用剂量根据患者不同情况而定),观察2组患者治疗前后不同时点的血糖变化、血糖达标时间、平均胰岛素用量、低血糖发生率、术后切口感染率及住院天数的变化.结果 CSII组治疗后各时点血糖控制及其其他相关指标均优于MSII组,即CSII组治疗后空腹血糖[(4.8±1.6)mmol/L]控制效果优于MSII组[(6.4±2.1)mmol/L](t=7.74,P<0.05);早餐后2 h血糖控制效果[(7.6±2.3)mmol/L]优于MSII组[(9.3±2.4)mmol/L](t=7.72,P<0.05);血糖迭标时间[(4.1±2.9)d]明显短于MSII组[(6.9±2.0)d](t=2.81,P<0.05);平均胰岛素用量[(40.7±10.3)U]明显少于MSII组[(63.2±17.0)U](t=3.57,P<0.05);低血糖发生率(9.20%)较MSII组(3.05%)低(χ~2=4.92,P<0.05);CSII组切口感染率(0.0%)较MSII组(10.9%)低(χ~2=4.18,P<0.05);住院天数[(15.3±7.2)d]明显短于MSII组[(22.5±9.7)d](t=3.12,P<0.05).结论 2型糖尿病患者在围手术期应用持续皮下胰岛素输注控制血糖迅速、有效、安全.     

胰岛素泵与多次胰岛素皮下注射强化治疗2型糖尿病疗效比较

目的:比较胰岛素泵与多次胰岛素皮下注射两种强化治疗方案控制血糖的有效性和安全性。方法:选取需要强化治疗2型糖尿病患者67例,随机分为2组。胰岛素泵组(CSII组)29例,多次胰岛素皮下注射组(MSII组)38例。对2组病例均行三餐前后及睡前指血血糖监测情况并进行分析,比较2组治疗后7点血糖、血糖达标时间、胰岛素用量及低血糖的发生率。结果:2组治疗后7点血糖均有显著下降,但CSII组空腹血糖及三餐后血糖下降幅度优于MSII组(P0.05)。CSII组达标时间是(4.68±1.28)d,显著短于MSII组;CSII组在达标时胰岛素剂量为(30.09±10.09)U/d,显著少于MSII组。轻度低血糖发作次数,CSII组显著少于MSII组(p0.05)。结论:两种胰岛素强化治疗方案均能够有效控制T2DM患者的血糖,促进短期血糖达标。CSII治疗在降低血糖方面更显著,并能够缩短血糖达标时间,减少胰岛素用量和降低低血糖的发生率。     

危重症血糖的初步探讨

目的探讨危重患者不同组的血糖、血清胰岛素和C肽的差别,分析各组内血糖与胰岛素、C肽的相关性。方法选择2010年5月至2011年12月入住深圳市福田区人民医院ICU病房的222例危重患者,测定24 h内的血糖、血清胰岛素、C肽及进行急性生理和慢性健康状况Ⅱ评分(acute physiology and chronic health evaluationⅡ,APACHEⅡ评分)。按病史分为糖尿病组及对照组,比较两组间的血糖、血清胰岛素、C肽水平,分析不同组别的血糖与血清胰岛素、C肽的相关性。结果对照组血糖[(8.2±3.5)mmol/L]高于糖尿病组[(7.7±2.1)mmol/L],但两组比较差异无统计学意义(P>0.05);糖尿病组血清胰岛素[(67±110)μIu/ml]高于对照组[(11±8)μIu/ml],差异无统计学意义(P>0.05);对照组C肽[(4.6±1.0)μg/L]高于糖尿病组[(1.8±1.8)μg/L)],差异有统计学意义(P<0.05)。两组血糖与血清胰岛素、C肽无直线相关。结论 ICU危重症糖尿病与非糖尿病患者出现同样血糖、血清胰岛素。反应胰岛细胞功能的C肽,非糖尿病患者高于糖尿病患者。危重症患者血糖与血清胰岛素、C肽无线性相关。     

胰岛素泵治疗糖尿病的临床研究

目的 :比较两种不同的胰岛素给药方法对血糖控制不良的糖尿病患者的疗效和不良反应。方法 :79例需要胰岛素治疗的血糖控制不良的糖尿病患者给与 :①胰岛素泵皮下连续输注 (CSII组 :3 9例 ,含 1型糖尿病 11例 ,2型糖尿病 2 8例 ) ;②多次皮下注射法 (MSII组 :40例 ,含 1型糖尿病 11例 ,2型糖尿病 2 9例 )。两组治疗的靶血糖值 :空腹血糖≤ 6 0mmol/L ,非空腹血糖≤8 0mmol/L ,并至少两天。结果 :两种治疗均可达到相同的靶血糖值 ,CSII较MSII在更短时间内达靶血糖值〔CSII组 (10 6± 0 7)天 ,MSII组 (17 3± 1 2 )天 ,P <0 0 5〕 ,两组达靶血糖时平均胰岛素用量无差异〔CSII组 (4 3 3± 2 9)u/d ,MSII组 (4 5 7± 2 3 )u/d ,P >0 0 5〕。CSII组低血糖发生率及夜间低血糖发生率均较MSII组低。结论 :CSII较MSII更快 ,更安全 ,更平稳控制血糖。     

胰岛素泵在2型糖尿病胰岛素治疗中的应用及护理

目的比较不同胰岛素给药方法对2型糖尿病的治疗效果。方法对86例需胰岛素治疗的2型糖尿病住院患者进行了2种胰岛素强化治疗:胰岛素泵持续皮下治疗组(CSII组)42例和多次皮下注射胰岛素组(MSII组)44例。比较两组治疗前后血糖变化、血糖达标时间、血糖达标时每日胰岛素的使用总量及低血糖的发生率。结果两组患者最终均达到了目标血糖值,平均高血糖控制天数有显著性差异,CSII组:(7.84±4.13)d,MSII组:(10.26±3.26)d,(P<0.01),胰岛素用量CSII组:(37.57±7.86)U/d,MSII组:(40.26±6.25)U/d,无显著性差异(P>0.05)。而CSII组低血糖发生率低于MSII组,CSII组:(0.13±0.03)次/(人.d),MSII组:(0.24±0.06)次/(人.d),(P<0.01)。结论CSII组较MSII组更快更有效地控制高血糖,并减少低血糖的发生。     

儿童新发1型糖尿病院外治疗及监测方案对糖化血红蛋白的影响

目的 分析儿童新发1型糖尿病(T1DM)院外血糖控制情况,探讨不同的治疗方案和血糖监测方式对糖化血红蛋白(HbA1c)的影响。方法 回顾性分析昆明医科大学附属儿童医院内分泌遗传代谢科收治的新发T1DM患儿的临床资料,以出院9个月内HbA1c中位数为标准(7.0%),分为达标组和未达标组。将患儿根据胰岛素注射方式分为胰岛素泵持续皮下胰岛素输注(CSII)组及多次胰岛素皮下注射(MDI)组;根据治疗方案联合监测方案分为4组,即持续皮下胰岛素输注联合瞬感扫描式葡萄糖监测组(CSII联合FGMS组)、持续皮下胰岛素输注联合自我血糖监测组(CSII联合SMBG组)、多次胰岛素皮下注射联合瞬感扫描式葡萄糖监测组(MDI联合FGMS组)、多次胰岛素皮下注射联合自我血糖监测组(MDI联合SMBG组)。比较治疗方案及血糖监测方式对新发T1DM患儿血糖控制的影响。结果 共有48例新发T1DM患儿纳入本研究,其中HbA1c达标组(n=15)患儿年龄更小,CSII使用率及FGMS使用率更高,低血糖发生次数更少,差异均有统计学意义(P<0.05); 2组患儿性别、居住环境、监护人文化程度、体质量指数(BM...     

胰岛素泵强化治疗2型糖尿病30例临床护理

目的:探讨胰岛素泵持续皮下胰岛素注射(CSII)和多次皮下胰岛素注射(MDI)对2型糖尿病强化治疗的临床疗效及护理措施.方法:将60例2型糖尿病患者随机分为CSII组和MDI组各30例,CSII组采用胰岛素泵治疗,MDI组采用胰岛素笔治疗.比较两组血糖水平、血糖达标时间、胰岛素用量、低血糖发生率等情况.结果:CSII组在血糖达标时间、胰岛素用量及低血糖发生率方面与MDI组比较差异有显著性(P＜0.05).结论:CSII更能有效地控制血糖,节省胰岛素用量,降低低血糖的发生率,减少和延缓慢性并发症,提高生活质量.     

胰岛素泵治疗糖尿病的临床观察

目的观察比较短期胰岛素泵(CSII)和多次皮下注射胰岛素(MSII)强化治疗糖尿病患者高血糖的疗效及低血糖发生率。方法对空腹血糖≥11.1mmol/L的(122例)糖尿病患者随机分成CSII治疗组(52例)和MSII治疗组(70例),分析比较两组治疗前后血糖的变化,控制血糖达标的天数,低血糖发生率。结果胰岛素泵治疗组显示出快速稳定的降血糖效果,仅需(2.9±0.6)d即达到预期强化控制水平,且每个时段的血糖控制均较MSII组理想;而MSII组需(9.2±1.7)d才达到预期水平。二者有显著差异。低血糖发生率CSII组有9例次,而MSII组有21例次,二组差异显著(P<0.01)。结论对糖尿病高血糖的治疗显示:CSII控制血糖更为迅速、理想,低血糖发生率更低。     

固定糖类与固定胰岛素终剂量治疗老年糖尿病的观察与护理

[目的]尝试在老年糖尿病病人固定糖类摄入量的基础上联合强化胰岛素治疗,观察胰岛素最终剂量的可控性以及此种联合治疗的有效性与安全性。[方法]入选57例此前接受两针预混人胰岛素注射且血糖控制不良的住院病人,分为多次胰岛素注射组(MDI组)和胰岛素泵组(CSII组)治疗,两组均给予固定糖类摄入量,男200g/d,女150g/d,治疗15d,规定胰岛素最终剂量<50U/d,靶目标空腹血糖(FBG)<7.8mmol/L,餐后2h血糖(PBG2h)<10.0mmol/L。[结果]两组治疗后FBG、PBG2h均较治疗前下降,差异有统计学意义(P<0.05),且CSII组治疗后FBG较MDI组下降显著(P<0.05)。两组胰岛素剂量、低血糖发生率比较差异无统计学意义(P>0.05)。[结论]在固定糖类摄入量的基础上,实现胰岛素剂量未增加而获得良好的有效性与安全性。     

胰岛素泵治疗2型糖尿病临床研究

目的：比较研究胰岛素泵连续皮下输注治疗(CSII)和多次注射胰岛素强化治疗(MDI)分别对血糖控制差的2型糖尿病患者的临床疗效和安全性。方法：采用对照研究方法探讨MDI和CSII在血糖控制、胰岛素剂量、低血糖发生率、治愈天数等方面的差异。结果：CSII组治疗达到理想血糖控制的疗效和所需的时间明显短于MDI组；CSII组治疗达到理想血糖控制所需的胰岛素剂量明显少于MDI组；CSII组低血糖发生率明显低于MDI组。结论：CSII对血糖控制较差的2型糖尿病患者是一种安全、有效、方便和准确的控制血糖方法。     

Continuous subcutaneous insulin infusion (CSII) of insulin aspart versus multiple daily injection of insulin aspart/insulin glargine in type 1 diabetic patients previously treated with CSII

OBJECTIVE: Multiple daily injection (MDI) therapy of bolus insulin aspart and basal insulin glargine was compared with continuous subcutaneous insulin infusion (CSII) with aspart in type 1 diabetic patients previously treated with CSII. RESEARCH DESIGN AND METHODS: One hundred patients were enrolled in a randomized, multicenter, open-label, crossover study. After a 1-week run-in period with aspart by CSII, 50 subjects were randomly assigned to MDI therapy (aspart immediately before each meal and glargine at bedtime) and 50 subjects continued CSII. After 5 weeks of the first treatment, subjects crossed over to the alternate treatment for 5 weeks. During the last week of each treatment period, subjects wore a continuous glucose monitoring system for 48-72 h. RESULTS: Mean serum fructosamine levels were significantly lower after CSII therapy than after MDI therapy (343 +/- 47 vs. 355 +/- 50 micromol/l, respectively; P = 0.0001). Continuous glucose monitoring profiles over a 24-h time period showed that glucose exposure was 24 and 40% lower for CSII than MDI as measured by area under the curve (AUC) glucose >/=80 mg/dl (1,270 +/- 742 vs. 1,664 +/- 1,039 mg . h . dl(-1); P < 0.001) and AUC glucose >/=140 mg/dl (464 +/- 452 vs. 777 +/- 746 mg . h . dl(-1), CSII vs. MDI, respectively; P < 0.001). Similar percentages of subjects reported hypoglycemic episodes (CSII: 92%, MDI: 94%) and nocturnal (12:00 a.m. to 8:00 a.m.) hypoglycemic episodes (CSII: 73%, MDI: 72%). Major hypoglycemia was infrequent (CSII: two episodes, MDI: five episodes). CONCLUSIONS: In a trial of short duration, CSII therapy with insulin aspart resulted in lower glycemic exposure without increased risk of hypoglycemia, as compared with MDI with insulin aspart and glargine.     

Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens using insulin lispro in type 1 diabetic patients on intensified treatment: a randomized study. The Study Group for the Development of Pump Therapy in Diabetes

OBJECTIVE: To compare the efficacy of 2 intensified insulin regimens, continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI), by using the short-acting insulin analog lispro in type 1 diabetic patients. RESEARCH DESIGN AND METHODS: A total of 41 C-peptide-negative type 1 diabetic patients (age 43.5+/-10.3 years; 21 men and 20 women, BMI 24.0+/-2.4 kg/m2, diabetes duration 20.0+/-11.3 years) on intensified insulin therapy (MDI with regular insulin or lispro, n = 9, CSII with regular insulin, n = 32) were included in an open-label randomized crossover study comparing two 4-month periods of intensified insulin therapy with lispro: one period by MDI and the other by CSII. Blood glucose (BG) was monitored before and after each of the 3 meals each day. RESULTS: The basal insulin regimen had to be optimized in 75% of the patients during the MDI period (mean number of NPH injections per day = 2.65). HbA1c values were lower when lispro was used in CSII than in MDI (7.89+/-0.77 vs. 8.24+/-0.77%, P<0.001). BG levels were lower with CSII (165+/-27 vs. 175+/-33 mg/dl, P<0.05). The SD of all the BG values (73+/-15 vs. 82+/-18 mg/dl, P<0.01) was lower with CSII. The frequency of hypoglycemic events, defined as BG levels <60 mg/dl, did not differ significantly between the 2 modalities (CSII 3.9+/-4.2 per 14 days vs. MDI 4.3+/-3.9 per 14 days). Mean insulin doses were significantly lower with CSII than with MDI (38.5+/-9.8 vs. 47.3+/-14.9 U/day. respectively, P< 0.0001). CONCLUSIONS: When used with external pumps versus MDI, lispro provides better glycemic control and stability with much lower doses of insulin and does not increase the frequency of hypoglycemic episodes.     

Continuous subcutaneous insulin infusion and multiple daily injection therapy are equally effective in type 2 diabetes: a randomized,parallel-group, 24-week study

OBJECTIVE: Compare the efficacy, safety, and patient satisfaction of continuous subcutaneous insulin infusion (CSII) therapy with multiple daily injection (MDI) therapy for patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: A total of 132 CSII-naive type 2 diabetic patients were randomly assigned (1:1) to CSII (using insulin aspart) or MDI therapy (bolus insulin aspart and basal NPH insulin) in a multicenter, open-label, randomized, parallel-group, 24-week study. Efficacy was assessed with HbA(1c) and eight-point blood glucose (BG) profiles. Treatment satisfaction was determined with a self-administered questionnaire. Safety assessments included adverse events, hypoglycemic episodes, laboratory values, and physical examination findings. RESULTS: HbA(1c) values decreased similarly for both groups from baseline (8.2 +/- 1.37% for CSII, 8.0 +/- 1.08% for MDI) to end of study (7.6 +/- 1.22% for CSII, 7.5 +/- 1.22% for MDI). The CSII group showed a trend toward lower eight-point BG values at most time points (only significant 90 min after breakfast; 167 +/- 48 vs. 192 +/- 65 mg/dl for CSII and MDI, respectively; P = 0.019). A total of 93% of CSII-treated subjects preferred the pump to their previous injectable insulin regimen for reasons of convenience, flexibility, ease of use, and overall preference. Safety assessments were comparable for both treatment groups. CONCLUSIONS: Insulin aspart in CSII therapy provided efficacy and safety comparable to MDI therapy for type 2 diabetes. Patients with type 2 diabetes can be trained as outpatients to use CSII and prefer CSII to injections, indicating that pump therapy should be considered when initiating intensive insulin therapy for type 2 diabetes.     

A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine

OBJECTIVE: The efficacy of the insulin analogs now available for multiple daily injection (MDI) and continuous subcutaneous insulin infusion (CSII) therapy in type 1 diabetes has not yet been established in pediatric patients. Our principal aim in this short-term study was to compare the efficacy of CSII to MDI with glargine in lowering HbA(1c) levels in children and adolescents with type 1 diabetes. RESEARCH DESIGN AND METHODS: Thirty-two youth with type 1 diabetes (age 8-21 years) were randomly assigned to receive either MDI treatment with once-daily glargine and premeal/snack insulin aspart or CSII with insulin aspart. Dose titration in both groups was based on home self-monitored blood glucose measurements and monthly HbA(1c). HbA(1c), total daily insulin dose (TDD), self-monitored blood glucose readings, and adverse events were compared after 16 weeks of therapy. RESULTS: While there was no significant change in the glargine group (HbA(1c) 8.2% at baseline vs. 8.1% at 16 weeks), youth randomized to CSII had a sharp reduction in HbA(1c) levels, from 8.1 to 7.2% after 16 weeks of therapy (P < 0.02 vs. baseline and <0.05 vs. glargine group). TDD was unchanged in the glargine group, but significantly dropped with CSII (1.4 units/kg at baseline vs. 0.9 units/kg at 16 weeks, P < 0.01). Both groups had similar basal doses and insulin-to-carbohydrate ratios. Fasting self-monitored blood glucose was similar in both groups, but lunch, dinner, and bedtime readings were significantly lower in the CSII group (P < 0.01). CONCLUSIONS: Lower HbA(1c) and premeal glucose levels were more achievable in this short-term study with CSII than with glargine-based MDI treatment. CSII is an efficacious treatment to improve metabolic control in youth with type 1 diabetes.     

Comparison of plasma glucose and plasma free insulin during CSII and intensified conventional insulin therapy

The plasma glucose and plasma free insulin profiles of six totally insulin-dependent diabetic patients were compared during periods of 4 days in hospital under a conventional insulin therapy (ICIT) comprising 4 daily injections of regular insulin and under continuous subcutaneous insulin infusion (CSII). Two profiles of prandial insulin administration with CSII were compared: a rectangular (R) and an exponential wave (E) in which 50% of the dose was given rapidly followed by an exponential decrease. In both cases, the basal infusion rate was increased by 30-50% between 5 a.m. and 8 a.m. Mean circadian blood glucose was equally good with ICIT: R and E: 7.0 +/- 0.9, 7.3 +/- 1.0, and 7.1 +/- 1.0 mmol/L, respectively. In five patients, fasting plasma glucose was higher with ICIT than with R and E (12.7 +/- 1.8 versus 6.9 +/- 1.0 and 6.8 +/- 0.8 mmol/L, respectively; t test: P less than 0.05; Wilcoxon: P = 0.06). Mean plasma free insulin level was significantly higher (t test: P less than 0.005; Wilcoxon: P less than 0.05) with ICIT (0.46 +/- 0.04 nmol/L) than with R (0.37 +/- 0.04 nmol/L) or E (0.36 +/- 0.05 nmol/L), although the daily doses were similar. In conclusion, CSII leads to a better glycemic control than ICIT, since it appears to prevent the morning rise of blood glucose.     

Incidence of hypoglycemic episodes in diabetic patients under continuous subcutaneous insulin infusion and intensified conventional insulin treatment: assessment by means of semiambulatory 24-hour continuous blood glucose monitoring

The incidence and magnitude of hypoglycemia (i.e., blood glucose values less than 50 mg/dl) were assessed by continuous blood glucose monitoring over 24 h in 10 insulin-dependent diabetic (IDD) patients treated with continuous subcutaneous insulin infusion (CSII) and 9 IDD patients under intensified conventional treatment (ICT). A newly developed, battery-powered blood glucose monitor was employed. Patients were thus enabled to move freely in the hospital premises. Despite similar quality of previous blood glucose control (HbA1: 8.0 +/- 0.05% CSII versus 8.0 +/- 0.3% ICT, mean +/- SEM), the obtained profiles showed better regulation under CSII treatment (mean blood glucose [MBG], 99.6 +/- 10.0 versus 133.1 +/- 7.4 mg/dl; M-value, 12.3 +/- 3.5 versus 26.2 +/- 4.1; mean amplitude of glycemic excursion [MAGE], 71.9 +/- 8.7 versus 132.9 +/- 14.2 mg/dl; CSII versus ICT, mean +/- SEM). The incidence of blood glucose values less than 50 mg/dl was 9/10 patients (CSII) and 5/9 patients (ICT). In both groups, hypoglycemia was most frequent at noon and was related to elevated pre- and postprandial free insulin levels. Patients became aware of hypoglycemia only in 6/23 episodes (CSII) and 6/8 episodes (ICT). Our data indicate that CSII as well as ICT may result in postprandial hyperinsulinemia leading to frequent hypoglycemic episodes of variable length, reassessing the traditional experience of close correlation between aggressive insulin therapy and enhanced hypoglycemic risk.     

The effect of continuous subcutaneous insulin infusion on endogenous insulin secretion in type I diabetes

In an attempt to elucidate possible mechanisms for the success of continuous subcutaneous insulin infusion (CSII), we evaluated the C-peptide response to a standard breakfast in seven type I diabetic patients while they were on conventional insulin treatment and again after 4 wk of near-normal glycemia achieved with CSII. While on conventional therapy their 24-h mean blood glucose level was 211 +/- 12 mg/dl and their glycosylated hemoglobin level was 10.6 +/- 0.6%. After 4 wk of CSII their 24-h mean blood glucose level fell to 95 +/- 7 mg/dl and their glycosylated hemoglobin level fell to 6.5 +/- 0.4%. Plasma C-peptide levels were undetectable in all seven patients both while on conventional therapy and after 4 wk of CSII. We conclude that the success of CSII is related to an improved method of insulin delivery and not to either the selection of type I diabetic patients who have some residual insulin secretory capacity or to some change in endogenous insulin secretion produced by the treatment itself.     

Overnight metabolic control with bedtime injection of intermediate-acting insulin or continuous subcutaneous insulin infusion

Ten insulin-dependent diabetic patients were investigated from 2100 to 0700 h during treatment with either a bedtime injection (BI) of intermediate-acting insulin or continuous subcutaneous insulin infusion (CSII) at a constant basal rate. In the evening, blood glucose was slightly higher during treatment with BI than with CSII, whereas the metabolic control in the morning was equal on both regimens with a fasting blood glucose of 5.7 mM (4.2-7.1) (median and interquartile ranges) on BI and 5.4 mM (4.6-5.8) on CSII (NS). No rise in morning blood glucose was seen, but serum beta-hydroxybutyrate tended to rise (NS). There was a significant hyperinsulinemia at midnight during BI compared with CSII with a serum free insulin of 14.5 (11.7-16.0) vs. 9.6 (7.2-11.2) mU/L (P less than .05), respectively, and the area under the curve during the middle of the night (midnight to 0400 h) was greater with BI than CSII (P less than .02). A greater fall in blood glucose was seen with BI than with CSII during this period (P less than .02). Differences in blood glucose and serum free-insulin profiles between those using NPH or lente insulin at bedtime were registered. We conclude that, although the same metabolic control in the morning was achievable with CSII at a constant basal rate and BI, CSII is superior for overnight metabolic control due to less-pronounced hyperinsulinemia during the night and a steady-state level of free insulin in the morning.     

Intensive insulin therapy with insulin lispro: a randomized trial of continuous subcutaneous insulin infusion versus multiple daily insulin injection

OBJECTIVE: To evaluate glycemic control, hypoglycemic events, and quality of life in patients treated with continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injection (MDI), with insulin lispro as the principal insulin. RESEARCH DESIGN AND METHODS: This clinical trial enrolled 27 patients with type 1 diabetes. They were randomly assigned to CSII (n = 13) or MDI (n = 14) treatment regimens. Glycemic control (HbA(1c) level) was the primary outcome and was measured monthly for 9 months. Secondary outcomes were patient reports of hypoglycemic events (recorded monthly for 9 months) and quality of life assessed at 9 months using the Diabetes Quality of Life (DQOL) questionnaire. RESULTS: A significant decrease in HbA(1c) from baseline was shown for both groups. However, the overall treatment effect (CSII - MDI) for HbA(1c) was +0.08% (95% CI -0.23 to +0.39, P > 0.10). This was significantly less than the a priori limit of +/-0.5% (P = 0.004). The relative treatment effect ([CSII - MDI]/MDI) for the overall number of hypoglycemic events was +9% (95% CI -37 to +87, P > 0.10). There were no statistically significant differences between treatment groups for any of the DQOL subscales. CONCLUSIONS: No statistically significant differences in glycemic control, reported hypoglycemic events, or quality of life were found in this study. Furthermore, a clinically significant difference of more than +/-0.5% HbA(1c) between the two regimens can be confidently ruled out. We conclude that the choice of intensive insulin therapy should be a matter of patient preference, consistent with lifestyle.     

Effects of continuous subcutaneous insulin infusion versus multiple injections on insulin receptors in insulin-dependent diabetics

We compared continuous subcutaneous insulin infusion (CSII) versus multiple injections (MI) in the treatment of insulin-dependent diabetes mellitus (IDDM) to assess the effect of glucose control on monocyte insulin receptors. Each IDDM patient (n = 8) was treated for 2 mo by MI (HS Ultralente and AC boluses of regular insulin) and for 2 mo by CSII in a randomized fashion. Prestudy preprandial/postprandial blood glucose levels were 199 +/- 33/261 +/- 28 mg/dl and improved to 124 +/- 12/156 +/- 13 mg/dl during MI and to 115 +/- 11/151 +/- 11 mg/dl during CSII. Glycosylated hemoglobin before the study was 10.1 +/- 0.5% and decreased to 8.8 +/- 0.4 and 8.3 +/- 0.3% during MI and CSII, respectively. The specific 125I-labeled insulin binding to circulating monocytes in a group of nonobese controls (n = 17) was 4.6 +/- 0.2%. In our poorly controlled diabetics during conventional therapy, the 125I-insulin binding was decreased to 3.7 +/- 0.3 (P less than .025). This was not significantly affected by MI despite good glucose control (4.0 +/- 0.3%). With CSII, however, good glucose control was associated with normalization of 125I-insulin binding to monocytes (4.7 +/- 0.27%). The affinity of the insulin receptors was normal before the study and was not affected by either MI or CSII. In conclusion, these observations demonstrate that in IDDM, intensive therapy by MI and CSII resulted in similar good glucose control, but only CSII resulted in normalization of insulin receptors on circulating monocytes.