Multiple Daily Insulin Injections Group Research Articles

MDI versus CSII in Chinese adults with type 1 diabetes in a real-world situation: based on propensity score matching method

BackgroundCompared with multiple daily insulin injections (MDI), continuous subcutaneous insulin infusion (CSII) is significantly more expensive and has not been widely used in Chinese type 1 diabetes mellitus (T1DM) patients. So there are still significant knowledge gaps regarding clinical and patient-reported outcomes in China.AimsThis study aims to compare the glycated hemoglobin (HbA1C), insulin therapy related quality of life (ITR-QOL), fear of hypoglycemia (FOH) of adult T1DM patients treated with MDI and CSII based on propensity score matching in real-world conditions in China.MethodsFour hundred twenty adult T1DM patients who were treated with MDI or CSII continuously for more than 12 months in a national metabolic center from June 2021 to June 2023 were selected as the study subjects. Their QOL and FOH were evaluated with Insulin Therapy Related Quality of Life Measure Questionnaire-Chinese version (ITR-QOL-CV) and the Chinese Version Hypoglycemia Fear Survey-Worry Scale (CHFSII-WS), and their HbA1C were collected at the same time. Potential confounding variables between the two groups were matched using propensity score matching.ResultsOf the 420 patients included in the study, 315 were in MDI group and 105 were in CSII group. 102 pairs were successfully matched. After matching, the total score of ITR-QOL-CV scale in CSII group was significantly higher than that in MDI group (87.08 ± 13.53 vs. 80.66 ± 19.25, P = 0.006). Among them, the dimensions of daily life, social life, and psychological state were all statistically different (P < 0.05). The scores of CHFSII-WS (8.33 ± 3.49 vs. 11.77 ± 5.27, P = 0.003) and HbA1C (7.19 ± 1.33% vs. 7.71 ± 1.93%, P = 0.045) in CSII group were lower than those in MDI group.Conclusions25.0% of T1DM adults are treated with CSII. Compared with adult T1DM patients treated with MDI, those treated with CSII have higher ITR-QOL, less FoH, and better control of HbA1C in real-world conditions in China. Therefore, regardless of economic factors, CSII is recommended for adult T1DM patients to optimize the therapeutic effect and outcomes.

Insulin pump treatment vs. multiple daily insulin injections in patients with poorly controlled Type 2 diabetes mellitus: a comparison of cardiovascular effects

AimsBoth hyperglycaemia and large glycaemic variability are associated with worse outcomes in patients with Type 2 diabetes mellitus (T2DM), possibly causing sympatho-vagal imbalance and endothelial dysfunction. Continuous subcutaneous insulin injection (CSII) improves glycemic control compared to multiple daily insulin injections (MDI). We aimed to assess whether CSII may improve cardiac autonomic and vascular dilation function compared to MDI.MethodsWe enrolled T2DM patients without cardiovascular disease with poor glycaemic control, despite optimized MDI therapy. Patients were randomized to continue MDI (with multiple daily peripheral glucose measurements) or CSII; insulin dose was adjusted to achieve optimal target ranges of blood glucose levels. Patients were studied at baseline and after 6 months by: 1) flow-mediated dilation (FMD) and nitrate-mediated dilation (NMD) of the brachial artery; 2) heart rate variability (HRV) by 24-hour ECG Holter monitoring (HM). 7-day continuous glucose monitoring (CGM) was performed in 9 and 8 patients of Group 1 and 2, respectively.ResultsOverall, 21 patients were enrolled, 12 randomized to CSII (Group 1) and 9 to MDI (Group 2). The daily dose of insulin and Hb1AC did not differ significantly between the 2 groups, both at baseline and at follow-up. Glucose variability showed some significant improvement at follow-up in the whole population, but no differences were observed between the 2 groups. Both FMD and NMD, as well as HRV parameters, showed no significant differences between the 2 groups at 6-month follow-up.ConclusionsIn this randomized small study we show that, in T2DM patients, CSII achieves a similar medium-term glycemic control compared to MDI, without any adverse effect on the cardiovascular system.

Insulin pump treatment vs. multiple daily insulin injections in patients with poorly controlled type 2 diabetes mellitus: a comparison of cardiovascular effects

Abstract Background Both hyper- and hypo-glycaemia, as well as large glycaemic variability (GV) are associated with increased cardiovascular events in patients with type 2 diabetes mellitus (T2DM); possible contributing mechanisms of the increased cardiovascular risk include endothelial dysfunction and cardiac sympatho-vagal imbalance. Recent studies suggest that continuous subcutaneous insulin infusion (CSII) improves glycaemic control compared to multiple daily insulin injections (MDI). Purpose In this study, we assessed whether CSII may improve cardiac autonomic and vascular dilation function compared to MDI. Methods We enrolled in a small randomized pilot study consecutive T2DM patients without cardiovascular disease with poor glycaemic control, despite optimized MDI therapy. Patients were randomized to CSII (Group 1) or to continue MDI (Group 2); insulin dose was adjusted to achieve optimal glycaemic target ranges. Patients were studied at baseline and after 6 months by: 1) assessment of flow-mediated dilation (FMD) and nitrate-mediated dilation (NMD) of the brachial artery; 2) heart rate variability (HRV) by 24-hour ECG Holter monitoring; 3) a 7-day continuous glucose monitoring (CGM) was performed at baseline and follow-up in 8 and 7 patients of Group 1 and 2, respectively. Results Overall, 21 patients were enrolled, 12 randomized to CSII and 9 to MDI. Daily insulin dose, glycated hemoglobin levels and CGM parameters did not differ significantly between the 2 groups, both at baseline and at follow-up. Both FMD (6.7±2.5 vs 4.6±2.0 %, p=0.51) and NMD (8.9±3.1 vs 7.0±3.0 %, p=0.18), as well as HRV parameters, showed no significant differences between the 2 groups at 6-month follow-up. No relation between GV and both peripheral dilator function and cardiac autonomic function was also detected. Conclusions In this small, randomized pilot study we show that, in T2DM patients, CSII achieves similar medium-term glycaemic control compared to MDI, without any significant adverse effect on the cardiovascular system.

Evaluation of Lipohypertrophy in Patients With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injections or Continuous Subcutaneous Insulin Infusion

ObjectiveTo determine lipohypertrophy (LH) in patients with type 1 diabetes mellitus (T1DM) on multiple daily insulin injections (MDII) or continuous subcutaneous insulin infusion (CSII) and to reveal the factors associated with the development and severity of LH. MethodsSixty-six patients with T1DM treated with MDII (n = 35, 53%) or CSII (n = 31, 47%) for at least 1 year were included. LH localizations were detected with palpation and ultrasonography (USG). ResultsThe LH detection rate with USG was significantly higher than that by palpation in the whole group (P < .001). The LH was detected with USG in 30 (85.7%) patients in the MDII group and 22 (71.0%) patients in the CSII group (P = .144). Advanced LH was detected in 13 (37.1%) of the patients treated with MDII and in 3 (9.7%) of the patients treated with CSII. LH was more severe in the MDII group than in the CSII group (P = .013). Diabetes duration and length of infusion set use were significantly longer and body mass index, hypoglycemia, and complication rates were higher in patients with LH than those in patients without LH (P < .05). A positive correlation was found between LH severity and HbA1C and insulin dose (P < .05, for both). MDII as insulin administration method, incorrect rotation, and a history of ketosis were found to be the most related factors with LH severity in a multiple linear regression analysis (P < .05). ConclusionUSG might be an effective approach for detecting and evaluating the severity of LH. MDII might cause more severe LH than CSII in patients with T1DM. In this study, LH was found to be associated mostly with incorrect rotation technique and a history of ketosis.

Factors associated with glycemic variability in children with type 1 diabetes mellitus based on flash glucose monitoring system.

Patients with classical type 1 diabetes mellitus (T1DM) require lifelong dependence on exogenous insulin therapy due to pancreatic beta-cell destruction and absolute insulin deficiency. T1DM accounts for about 90% of children with diabetes in China, with a rapid increase in incidence and a younger-age trend. Epidemiological studies have shown that the overall glycated haemoglobin (HbA1c) and compliance rate are low in Chinese children with T1DM. Optimal glucose control is the key for diabetes treatment, and maintaining blood glucose within the target range can prevent or delay chronic vascular complications in patients with T1DM. Therefore, this study aims to investigate the glycemic control of children with T1DM from Hunan and Henan Province with flash glucose monitoring system (FGMS), and to explore factors associated with glycemic variability. A total of 215 children with T1DM under 14 years old were enrolled continuously in 16 hospitals from August 2017 to August 2020. All subjects wore a FGMS device to collect glucose data. Correlation of HbA1c, duration of diabetes, or glucose scan rates with glycemic variability was analyzed. Glucose variability was compared according to the duration of diabetes, HbA1c, glucose scan rates and insulin schema. HbA1c and duration of diabetes were positively correlated with mean blood glucose, standard deviation of glucose, mean amplitude of glucose excursions (MAGE), and coefficient of variation (CV) of glucose (all P<0.01). The glucose scan rates during FGMS wearing was significantly positively correlated with time in range (TIR) (P=0.001) and negatively correlated with MAGE and mean duration of hypoglycemia (all P<0.01). Children with duration ≤1 year had lower time below range (TBR) and MAGE when compared with those with duration >1 year (all P<0.05). TIR and TBR in patients with HbA1c ≤7.5% were higher (TIR: 65% vs 45%, TBR: 5% vs 4%, P<0.05), MAGE was lower (7.0 mmol/L vs 9.4 mmol/L, P<0.001) than those in HbA1c >7.5% group. Compared to the multiple daily insulin injections group, TIR was higher (60% vs 52%, P=0.006), MAGE was lower (P=0.006) in the continuous subcutaneous insulin infusion group. HbA1c was lower in the high scan rates (≥14 times/d) group (7.4% vs 8.0%, P=0.046), TIR was significantly higher (58% vs 47%, P<0.001), and MAGE was lower (P<0.001) than those in the low scan rate (<14 times/d) group. The overall glycemic control of T1DM patients under 14 years old in Hunan and Henan Province is under a high risk of hypoglycemia and great glycemic variability. Shorter duration of diabetes, targeted HbA1c, higher glucose scan rates, and CSII are associated with less glycemic variability.

Continuous subcutaneous insulin infusion therapy is associated with reduced retinopathy progression compared with multiple daily injections of insulin

Aims/hypothesisWe aimed to compare diabetic retinopathy outcomes in people with type 1 diabetes following introduction of continuous subcutaneous insulin infusion (CSII) therapy with outcomes in people receiving continuing therapy with multiple daily insulin injections (MDI).MethodsThis is a retrospective cohort study using the Scottish Care Information – Diabetes database for retinal screening outcomes and HbA1c changes in 204 adults commenced on CSII therapy between 2013 and 2016, and 211 adults eligible for CSII during the same period but who continued on MDI therapy. Diabetic retinopathy progression (time to minimum one-grade worsening in diabetic retinopathy from baseline grading) was plotted for CSII and MDI cohorts using Kaplan–Meier curves, and outcomes were compared using multivariate Cox regression analysis adjusting for age, sex, baseline HbA1c, blood pressure, cholesterol, smoking status and socioeconomic quintile. Impact of baseline HbA1c and change in HbA1c on diabetic retinopathy progression was assessed within CSII and MDI cohorts.ResultsCSII participants were significantly younger, were from less socially deprived areas, and had lower HbA1c and higher diastolic BP at baseline. There was a larger reduction in HbA1c at 1 year in those on CSII vs MDI (−6 mmol/mol [−0.6%] vs −2 mmol/mol [−0.2%], p < 0.01). Diabetic retinopathy progression occurred in a smaller proportion of adults following commencement of CSII vs continued MDI therapy over mean 2.3 year follow-up (26.5% vs 18.6%, p = 0.0097). High baseline HbA1c (75 mmol/mol [9%]) was associated with diabetic retinopathy progression in the MDI group (p = 0.0049) but not the CSII group (p = 0.93). Change in HbA1c at follow-up, irrespective of baseline glycaemic status, did not significantly affect diabetic retinopathy progression in either group.Conclusions/interpretationCSII was associated with reduced diabetic retinopathy progression compared with continued MDI therapy, and may be protective against diabetic retinopathy progression for those with high baseline HbA1c. Progression of diabetic retinopathy over 3 years was not associated with a change in HbA1c.Graphical abstract

Influence of Metabolic Parameters and Treatment Method on OCT Angiography Results in Children with Type 1 Diabetes.

Aim To evaluate the influence of metabolic parameters and the treatment method in children with type 1 diabetes (T1D) on the optical coherence tomography angiography (OCTA) results as early markers of diabetic retinopathy (DR). Material and Methods. This prospective study enrolled 175 consecutive children with T1D. OCTA was performed using AngioVue (Avanti, Optovue). Whole superficial capillary vessel density (wsVD), fovea superficial vessel density (fsVD), parafovea superficial vessel density (psVD), whole deep vessel density (wdVD), fovea deep vessel density (fdVD), parafovea deep vessel density (pdVD), foveal thickness (FT), parafoveal thickness (PFT), and foveal avascular zone (FAZ) in superficial plexus were evaluated and analyzed in relation to individual characteristics, i.e., sex, weight, height, body mass index (BMI), and metabolic factors: current and mean value of glycated hemoglobin A1c (HbA1c). Furthermore, the analysis concerned the diabetes duration, age at the T1D onset, and type of treatment—multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII). Results In the study group, we did not identify any patient with DR in fundus ophthalmoscopy. Age at the onset of diabetes correlated negatively with FAZ (r = −0.17, p < 0.05). The higher level of HbA1c corresponded to a decrease of wsVD (r = −0.13, p < 0.05). We found significantly lower fsVD (32.25 ± .1 vs. 33.98 ± .1, p < 0.01), wdVD (57.87 ± .1 vs. 58.64 ± .9, p < 0.01), and pdVD (60.60 ± .2 vs. 61.49 ± .1, p < 0.01) and larger FAZ area (0.25 ± .1 vs. 0.23 ± .1, p < 0.05) in the CSII vs. MDI group. Conclusion The metabolic parameters, age of the onset of diabetes, and treatment method affected the OCTA results in children with T1D. Further studies and observation of these young patients are needed to determine if these findings are important for early detection of DR or predictive of future DR severity.

Continuous subcutaneous insulin infusion reduces the risk of postoperative infection.

Perioperative hyperglycemia was associated with postoperative infection, and proper management of perioperative glucose has become critical in improving the prognosis of patients. A total of 1015 diabetic patients who underwent surgery and received insulin treatment for their hyperglycemia in our hospital were retrospectively reviewed. According to propensity matching, we obtained 253 pairs of patients from the group which received continuous subcutaneous insulin infusion (CSII) therapy (CSII group) and the group which received insulin injection therapy (non-CSII group). Perioperative glucose levels and corresponding outcomes were compared between the two groups. Compared with the non-CSII group, the CSII group had lower fasting and mean glucose levels, lower incidence of fever (operation day: 18.6% vs 10.2%; P = .014; first postoperative day: 55.1% vs 34.7%; P < .001), a positive rate of postoperative secretion culture (6.3% vs 1.2%; P = .004), and a shorter time of antibiotics use (total antibiotics use: P = .002; postoperative antibiotics use: P < .001) and hospital stays (P < .001). However, there was no difference in the total medical expenditure between the two groups (P = .499). Further analysis showed that CSII therapy was superior to multiple daily insulin injection (MDI) therapy in its effect on infection and other postoperative outcomes when 64 pairs of patients from the CSII group and MDI group were compared. CSII therapy provides better perioperative glucose control and a lower risk of postoperative infection without increasing the total medical expenditure.

123-LB: Continuous Subcutaneous Insulin Infusion from Diagnosis of Type 1 Diabetes Improves Intermediate Glycaemic Variability in Children

Background: Glucose variability (GV) may be reflected by variation in either the short-term glucose levels (assessed by continuous glucose monitoring (CGM)) or the long-term by HbA1c or intermediate by 1,5-anhydroglucitol (1,5-AG). In patients with T1DM management by continuous subcutaneous insulin infusion (CSII) is usually associated with improved glycaemia compared to multiple daily insulin injections (MDI). Serum 1,5-anhydroglucitol (1,5-AG) correlates with GV on CGM in adult and pediatric T1D groups. It is not known whether CSII therapy without CGM improves intermediate GV. Methods: Blood was obtained from children (mean age 14.1 +/- 1.3 years) within 3-months of T1D diagnosis. Children were treated with CSII (n=12) or MDI (n=15) and followed for a further 1 to 3 time points (median, LQ-UQ 535, 519-563 days follow-up). GV was assessed measuring 1,5-anhydroglucitol (1,5-AG) (GlycoMark, Inc., Winston-Salem, NC). The mean difference, standard deviation (SD) and coefficient of variation (CV) of 1,5-AG and HbA1c was compared between treatment arms. Results: There was no difference between treatment modalities in baseline HbA1c (median, LQ-UQ 11.8, 10.2-13.5 % (105, 87-124 mmol/mol) vs. 12.6, 10.3-14.0 % (114, 89-130 mmol/mol) CSII vs. MDI) nor baseline 1,5-AG (median, LQ-UQ 2.8, 1.8-4.0 μg/mL vs. 3.6, 2.1-12.1 μg/mL CSII vs. MDI). 1,5-AG improved more (increased) in the CSII vs. MDI group (3.1 +/- 4.1 vs. -2.2 +/- 7.0 μg/ml respectively, P=0.029). This difference persisted following adjustment for the duration of follow-up. There was no significant difference in the HbA1c improvement between the CSII and MDI groups. There was no significant difference in the SD or CV of 1,5-AG or HbA1c between groups. Conclusions: Early use of CSII post-T1D-diagnosis in a pediatric population is associated with a higher 1,5-AG than with MDI therapy implying reduced glycaemic variability. Disclosure E.S. Scott: None. A.S. Januszewski: None. G. Fulcher: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Research &amp; Development, Merck Sharp &amp; Dohme Corp., Novo Nordisk Inc. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Research &amp; Development, Merck Sharp &amp; Dohme Corp., Novo Nordisk Inc. Research Support; Self; Novo Nordisk Inc. T. Jones: Research Support; Self; Dexcom, Inc., Medtronic MiniMed, Inc. Speaker's Bureau; Self; Eli Lilly and Company, Roche Diabetes Care. E.A. Davis: None. A.J. Jenkins: Advisory Panel; Self; Abbott, Australian Diabetes Society, Medtronic. Research Support; Self; Abbott, GlySens Incorporated, Medtronic, Mylan. Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk Inc.

Attitudes and habits of patients with type 1 diabetes during fasting Ramadan

ObjectiveFasting Ramadan is associated with changes in lifestyle patterns of patients with diabetes who choose to perform fasting. We aimed to determine the attitude and habits of patients with type 1 diabetes during fasting Ramadan. MethodsThe study comprised a prospective cohort of patients with type 1 diabetes who were on insulin pump or multiple daily insulin injections (MDI) regimen. Patient questionnaires included the frequency of self-monitoring of blood glucose (SMBG), the need to make changes in insulin regimen by patients, timings of insulin administration, performing carbohydrate counting and levels of physical activity. ResultsA total of 156 patients were studied (61 patients on insulin pump and 95 patients on MDI). Patients on pump therapy performed SMBG more frequently than those on MDI regimen (4.8 ± 1.4 and 3.7 ± 1.7 times per day, respectively, P = 0.001) and were more likely to perform carbohydrate counting (32.7% and 8.4% of pump and MDI patients, respectively, P < 0.001). There was no difference in the percentage of patients who made changes in insulin doses (74.5% of the pump group and 77.3% of MDI patients) or those who had any level of physical activity (12.5% of the pump group and 21.1% of the MDI group). The timing of administering meal insulin in relation to sunset meal was variable with a preference to taking the injection immediately at sunset. There was no difference in glucose control between both groups as measured by frucotsamine levels or the number of days that patients have to stop fasting. ConclusionFasting Ramadan is associated with significant and variable changes in the attitude and behaviors of patients with type 1 diabetes with no difference in glucose control between patients on insulin pump or MDI regimen. Further studies are needed to define the role of education and its effect on these attitudes and patient care in this population.ClinicalTrials.gov Identifier: NCT01941238.

Glycemic and Metabolic Effects of Liraglutide as Additive Treatment to Different Therapeutic Regimens in Type 2 Diabetes Patients Followed in Primary Care Clinics

Background: Liraglutide improved metabolic derangement in type 2 diabetes (T2D). The study aimed to measure changes in glycemic and metabolic parameters after addition of liraglutide in obese insulin-resistant T2D patients Methods: liraglutide was added to 45 Adult T2D patients, who were on 4 regimens as follows:18 on Sulphonylurea(SU), 9 on SU and Basal insulin, 3 on basal insulin and 15 on multiple daily insulin injections(MDIs). Five patients had history of cardiovascular diseases (CVD).The cohort was followed for 6 months and Liraglutide dose 0.6 escalated to 1.2 mg based on patient tolerance. Glycemic, metabolic and anthropometric parameters were measured every 3 months Results: Mean age and T2D duration were 51.5±12.9 and 11.6±1.6 years, respectively. Body weight significantly reduced from 98.7kg to 96.0kg, p&amp;lt; 0.001, with a mean difference of 3.39kg ± 5.6kg. Systolic blood pressure reduced from 131.7mmHg to 126.6mmHg (Diff. 6.1mmHg), p = 0.015 while Diastolic blood pressure reduced from 73.3mmHg to 68.6mmHg (Diff. 4.7mmHg), p = 0.026. Most HbA1c reduction observed in the liraglutide 1.2 mg dose group with changes from 9.8% to 8.2% (Diff. 1.6%); and also the most weight reduction observed in the 1.2 mg liraglutide dose group with changes from 103.3kg to 99.7kg (Diff. 3.6kg) compared to 0.6 and 1.8 mg dose groups. HbA1c reduction was largest in MDIs group from 10.2 to 8.6% (Diff. 1.6%). Meanwhile, the most weight reduction noticed in the treatment group on SU and Basal insulin from 97.2kg to 92.8kg (Diff. 4.4kg). Interestingly, patients with CVD had improved HbA1c with changes from 10.62% to 9.77% (Diff. 0.85%) and weight from 86.96kg to 85.72kg (Diff. 1.24kg) without evident hypoglycemia. Conclusions: Addition of liraglutide to different T2D therapeutic regimen in obese Insulin- resistant patients showed significant improvement in HbA1c, weight, and Blood pressure. These results support the use in primary care clinics. Disclosure T. Alharbi: None. A. Tourkmani: None. S. Altwaijri: None. M. Kofi: None.

Satisfaction of switching to combination therapy with lixisenatide and basal insulin in patients with type 2 diabetes receiving multiple daily insulin injection therapy: A randomized controlled trial.

Aims/IntroductionWe compared the satisfaction levels of patients with type 2 diabetes undergoing combination therapy with lixisenatide (LIX) and basal insulin with that of patients undergoing multiple daily insulin injection (MDI) therapy.Materials and MethodsThe study was a 12‐week open‐label, randomized, multicenter, controlled trial. Participants were Japanese patients with type 2 diabetes receiving MDI for >3 months. Patients were randomly assigned to each treatment cohort: (i) a group that continued MDI (MDI group); and (ii) a group that switched from MDI to combination therapy with LIX and basal insulin (LIX group). The primary outcome was change in Diabetes Treatment Satisfaction Questionnaire scores from baseline to 12 weeks between these two groups. Key secondary outcomes were glycated hemoglobin and body weight changes.ResultsA total of 31 patients were initially enrolled in the study, and 26 of them completed the study. The change in Diabetes Treatment Satisfaction Questionnaire scores in the LIX group was significantly greater compared with that in the MDI group. Mean changes in glycated hemoglobin levels were −0.05 ± 0.37% in the MDI group and 0.04 ± 0.38% in the LIX group (P = 0.36). Mean changes in body weight were +0.6 ± 1.8 kg in the MDI group and −2.5 ± 1.8 kg in the LIX group (P < 0.01).ConclusionsSwitching from MDI to combination therapy with LIX and basal insulin improved satisfaction levels while maintaining glycemic control in Japanese patients with type 2 diabetes.

High-intensity Exercise in Men with Type 1 Diabetes and Mode of Insulin Therapy.

The purpose of this study was to evaluate the impact of high intensity exercise on glucose levels and risk of metabolic decompensation in males with type 1 diabetes (T1D), depending on the method of insulin administration. The study comprised 29 males (aged 25.3±5.1 years; duration of diabetes 10.3±3.2 years) treated with continuous subcutaneous insulin infusion (CSII) or multiple daily insulin injections (MDI). Treadmill exercise test was performed twice in each patient until subjective exhaustion as maximum according to the Borg scale. All the patients achieved ≥85% of the maximal heart rate. Distance during the test was 4 500±1 400 m and 4 473±1 559 m in the MDI and CSII groups, respectively, which was achieved in 31±8 min. During the test and in the 6 h after, no clinically significant episodes of hypoglycemia occurred. Mean glucose levels did not exceed 10 mmol/L in most patients. The risk of the composite endpoint (hypoglycemia<3.8 mmol/L, hyperglycemia≥16.6 mmol/L, ketones≥0.6 mmol/L, and lactate>2.2 mmol/L) was higher in patients treated with MDI than CSII (OR3.75, 95%CI:1.22-11.52, p=0.02). In conclusion, planned high intensity physical effort in men with well-controlled T1D is metabolically safe. CSII shows greater metabolic advantage over MDI during and after high intensity exercise in men with T1D.

Retinal characteristics during 1year of insulin pump therapy in type 1 diabetes: a prospective, controlled, observational study.

To investigate changes in retinal metabolism, function, structure and morphology in relation to initiation of insulin pump therapy (continuous subcutaneous insulin infusion, CSII). Visual acuity, retinopathy level, dark adaptation kinetics, retinal and subfoveal choroidal thickness, macular perfusion velocities, retinal vessel diameters and blood oxygen saturations were measured at baseline and after 1, 4, 16, 32 and 52weeks in 31 patients with type 1 diabetes who startedCSII and 20 patients who continued multiple daily insulin injections (MDI). One year of CSII reduced haemoglobin A1c (HbA1c ) by 1.6% (17.8mmol/mol) compared with 0.3% (3.1mmol/mol) in the MDI group (p<0.0001). Central retinal thickness increased by 1.5% in the CSII group (within-group p=0.0098; between-group p=0.063) without producing macular oedema. No detectable change was found in any other primary outcome measure. The proportion of patients with retinopathy worsening did not differ between groups. At baseline, longer disease duration was associated with higher retinal artery oxygen saturation (p=0.014) and lower macular venous perfusion velocity (p=0.045). One year of CSII led to an HbA1c reduction relative to continued MDI and a small increase in retinal thickness but not to early retinopathy worsening or to changes in retinal vascular, structural or functional characteristics. Longer duration of type 1 diabetes appears to be associated with lower macular venous perfusion velocity and higher retinal artery oxygen saturation. The latter could potentially reflect cumulative glycaemia.

Efficacy and safety of short-term sensor-augmented insulin-pump therapy for poorly controlled patients with type 1 diabetes mellitus

Objective To evaluate the efficacy and safety of short-term sensor-augmented insulin-pump (SAP) therapy for poorly controlled patients with type 1 diabetes mellitus (T1DM). Methods Sixty T1DM patients with glycosylated hemoglobin (HbA1c)>9.0% were randomly assigned to 2 groups treated with SAP or multiple daily insulin injection (MDI) for 6 days, then all patients converted to MDI therapy. Results Compared with MDI group and before therapy, the mean blood glucose concentration (MBG), SD of blood glucose, mean amplitude of glycemic excursion (MAGE) and 24-h area under curve at 10.0 (AUC10.0) levels in SAP group significantly decreased after 6-day therapy (compared with MDI group: t=1.761, P=0.028, t=2.569, P=0.037, t=2.712, P=0.020, t=2.985, P=0.014, compared with before therapy: t=3.128, P=0.006, t=2.689, P=0.024, t=2.966, P=0.013, t=3.076, P=0.009); while there was no difference in 24-h area under curve at 3.9 (AUC3.9) between groups (P>0.05). After 1 month follow-up HbA1c levels decreased in SAP group (t=2.344, P=0.023) and were significantly lower than those in MDI group (t=1.844, P=0.035). There was no difference in daily insulin dosage, fasting C peptide (FCP) and postprandial 2 h C peptide (2 hCP) between two groups (P>0.05). Age (t=2.125, P=0.012) and SAP therapy (t=3.376, P=0.009) were independently correlated with the HbA1c after 1 month. Conclusion Short-term SAP therapy is effective and safe for poorly controlled T1DM patients with rapid glucose lowering and glycemic excursions reduction. Key words: Diabetes mellitus, type 1; Insulin infusion systems; Continuous glucose monitoring; Treatment outcome

A reliable serum C-peptide index for the selection of an insulin regimen to achieve good glycemic control in obese patients with type 2 diabetes: an analysis from a short-term study with intensive insulin therapy.

Insulin regimens achieving favorable glycemic control in patients with type 2 diabetes are expected to closely relate to residual insulin secretory ability. We herein attempted to identify a reliable C-peptide immunoreactivity (CPR) index as an insulin secretory marker that would contribute to the selection of an appropriate insulin regimen for patients with type 2 diabetes. We near-normalized blood glucose in 246 obese patients with type 2 diabetes using our protocol (which included short-term intensive insulin therapy, IIT), and administered an oral hypoglycemic agent (OHA). Based on responsiveness to OHA, patients were classified into three therapy groups: non-insulin therapy (n=78), basal-insulin supported oral therapy (BOT) (n=109), and multiple daily insulin injection (MDI) therapy (n=59). Glucagon-loading CPR increment (ΔCPR), fasting CPR (FCPR), CPR2h after breakfast (CPR2h), ratio of FCPR to fasting plasma glucose (CPI), CPI2h after breakfast (CPI2h), and secretory unit of islets in transplantation (SUIT) were assessed with receiver operating characteristic (ROC) and multiple logistic analyses to discriminate the MDI group from the other therapy groups. ROC analysis revealed that CPR2h had the greatest area under the curve and specificity. Multiple logistic analysis identified CPR2h and CPI2h as the most significant explanatory variables for identifying patients assigned to the MDI group. A postprandial serum CPR marker such as CPR2h or CPI2h was shown to be the best index for predicting an appropriate insulin regimen to achieve good glycemic control in obese patients with type 2 diabetes.

Quality of life in Danish children and adolescents with type 1 diabetes treated with continuous subcutaneous insulin infusion or multiple daily injections

The aims of the study were to compare health-related quality of life (HRQoL) in a National Danish population of children and adolescents with type 1 diabetes (T1D) treated with either continuous subcutaneous insulin injection (CSII) or multiple daily insulin injections (MDI), and to investigate whether HRQoL assessments were influenced by treatment duration. Participants were recruited through the Danish Registry for Diabetes in Childhood and Adolescence. A total of 700 children and adolescents (360 girls), 8-17 years, were included. Of these, 295 were treated with CSII (160 for more than one year) and 405 with MDI (238 for more than one year). Participants and their parents completed the Pediatric Quality of Life Inventory Diabetes and Generic Module. HbA1c was analyzed centrally. Parents reported children and adolescents on CSII for more than one year to have less diabetes-related symptoms and worry, less problems in communicating diabetes, and better generic functioning compared with those on MDI. Children and adolescents on CSII for more than one year reported less diabetes-related symptoms, but more treatment problems, and better generic functioning in all subscales except social functioning compared with those on MDI for more than one year. Comparing those on CSII and MDI for less than one year, no differences in HRQoL ratings were found, apart from better rating of treatment barriers in the MDI group. This Danish national study on HRQoL in children and adolescents on CSII or MDI showed better HRQoL in children and adolescents on long time CSII, particularly concerning generic HRQoL.

2. Insulin pump therapy in type 1 diabetes: Potential to be neuroprotective

Background Diabetic neuropathy is a common complication of diabetes. While strict glycaemic control through multiple daily insulin injections (MDII) or continuous subcutaneous insulin infusion (CSII) may reduce risk of neuropathy development, the potential differences in axonal function between CSII and MDII treated patients have not been evaluated. Objectives To establish if there were differences in axonal function between patients treated with MDII and CSII . Methods A total of 46 type 1 diabetic patients underwent a comprehensive neurological examination to identify the presence of neuropathy. Subsequently, 34 non-neuropathic type 1 diabetic patients were recruited and grouped according to insulin delivery method: MDII ( n = 20, 14M:6F, age 28.37 ± 1.67 yrs) or CSII ( n = 14, 9M:5F, age 27.77 ± 3.26 yrs). Nerve excitability testing, a technique that provides information regarding axonal ion-channel properties, was performed on the median nerve in all patients at baseline and 6–12 months. Groups were matched for age, gender, HbA1c%, BMI and disease duration. Excitability testing was also performed on 20 age-matched healthy controls. Results Subjects demonstrated pronounced alteration in numerous excitability parameters reflecting axonal dysfunction compared to controls. Greater abnormalities in markers of nerve membrane potential were noted in the MDII group compared to controls, including superexcitability ( p p p CSII patients. The differences between the two groups were noted in cross-sectional recordings and at 6–12 month follow-up. Conclusions CSII -treated patients have normal excitability values, in contrast to MDII -treated patients. The abnormalities in the MDII group reflect altered axonal membrane potential. Critically, the differences between the two groups are apparent even in the absence of neuropathy and are maintained at follow-up. These data provide a basis for studies investigating the neuroprotective potential of CSII in type 1 diabetic patients.

Postprandial serum C-peptide value is the optimal index to identify patients with non-obese type 2 diabetes who require multiple daily insulin injection: Analysis of C-peptide values before and after short-term intensive insulin therapy.

Type 2 diabetes is a progressive disease characterized by a yearly decline in insulin secretion; however, no definitive evidence exists showing the relationship between decreased insulin secretion and the need for insulin treatment. To determine the optimal insulin secretory index for identifying patients with non-obese type 2 diabetes who require multiple daily insulin injection (MDI), we evaluated various serum C-peptide immunoreactivity (CPR) values. We near-normalized blood glucose with intensive insulin therapy (IIT) over a 2-week period in 291 patients with non-obese type 2 diabetes, based on our treatment protocol. After improving hyperglycemia, we challenged with oral hypoglycemic agent (OHA), and according to the responsiveness to OHA, patients were classified into three therapy groups: OHA alone (n=103), basal insulin plus OHA (basal insulin-supported oral therapy [BOT]; n=56) and MDI (n=132). Glucagon-loading CPR increment (ΔCPR), fasting CPR (FCPR), CPR 2h after breakfast (CPR2h), the ratio of FCPR to FPG (CPI), CPI 2h after breakfast (CPI2h) and secretory unit of islets in transplantation (SUIT) were submitted for the analyses. Receiver operating characteristic (ROC) and multiple logistic analyses for these CPR indices were carried out. Many CPR values were significantly lower in the MDI group compared with the OHA alone or BOT groups. ROC and multiple logistic analyses disclosed that post-prandial CPR indices (CPR2h and CPI2h) were the most reliable CPR markers to identify patients requiring MDI. Postprandial CPR level after breakfast is the most useful index for identifying patients with non-obese type 2 diabetes who require MDI therapy.

Valoración de la satisfación y calidad de vida en pacientes con diabetes mellitus tipo 1 en tratamiento con infusión subcutánea continua de insulina comparado con multidosis de insulina

To assess the quality of life (QOL) and satisfaction (SF) in patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) compared with multiple daily insulin injections (MDI). A descriptive study was conducted to assess the QOL and SF of 68 patients on CSII or MDI treatment (1:2). The instruments used were, the Spanish version of the Diabetes Quality of Life (EsDQOL) specific for diabetes related QOL, SF-36 for general QOL, and the Diabetes Treatment Satisfaction Questionnaire (DTSQ) for SF evaluation. The EsDQOL scores for patients on CSII therapy were similar to those treated with MDI (87.20±21.11 vs 86.83±20.7, P=.86), with lower scores in the SF-36 questionnaire (66.91±15.76 vs 75.90±14.56, P=.03) except in Health Transition section, where patients treated with CSII showed higher scores (68.75±19.66 vs 57.93±17.18, p=.02). The values obtained in the DTSQ questionnaire were higher in CSII patients compared with the MDI group in last weeks (31.50±4.66 vs 27.83±6.06, p=.01) and last three months periods (13.2±6.73 vs 8.77±7.40, p=.01). Patients with T1DM on CSII therapy showed a poorer global QOL, although they felt more satisfied with their treatment than those treated with MDI. No differences in diabetes related QOL were detected between groups.