The Effect of Prandial Insulin Applied for Fat Protein Units on Postprandial Glucose Excursions in Type 1 Diabetes Patients with Insulin Pump Therapy: Results of a Randomized, Controlled, Cross-Over Study.

OBJECTIVE: This randomized cross-over study aimed to compare different algorithms for calculating prandial insulin considering the fat and protein content of a standardized meal in type 1 diabetes patients using insulin pump therapy (CSII). METHODS: Twenty-six patients received a standardized evening meal for three consecutive days using different algorithms for insulin dose adjustment: A) exclusive consideration of carbohydrate content without considering fat-protein content, B) high-dose algorithm considering additional insulin for fat protein units (FPUs) with the same factor as for carbohydrates, and C) low-dose algorithm considering additional insulin for FPUs with half the factor as for carbohydrates. The primary outcome was the proportion of interstitial glucose values in the target range (≥ 70 to ≤ 180 mg/dl) during the post-prandial 12-hour follow-up period. Secondary outcomes were the occurrence of hypo- and hyperglycemic episodes and the coverage with carbohydrates for treatment of hypoglycemia. RESULTS: The percentage of glucose values in the target range was significantly higher when fat-protein content was not considered, whereas, in the hyperglycemic range, it did not differ significantly among the three groups. The percentage of hypoglycemic glucose values were the highest in the groups considering fat-protein content and lowest in the group not considering FPUs with no significant difference between the two groups in terms of FPUs. CONCLUSIONS: In adult type 1 diabetes patients using CSII, it is not recommended to consider a high fat and protein content in the diet when calculating prandial insulin dosage with the selected algorithms, as this increases the risk of hypoglycemia disproportionately.

Efficacy of an Education Program for People With Diabetes and Insulin Pump Treatment (INPUT): Results From a Randomized Controlled Trial.

OBJECTIVE: Continuous subcutaneous insulin infusion (CSII) is the most advanced form of insulin delivery, but it requires structured education to provide users with the necessary knowledge/skills and to support their motivation. Currently, no structured education program designed to provide this training has been evaluated. We developed a CSII-specific, structured education program (Insulin Pump Treatment [INPUT]) and evaluated its impact on glycemic control, behavior, and psychosocial status. RESEARCH DESIGN AND METHODS: This was a multicenter, randomized, parallel trial with a 6-month follow-up. Eligible participants (age 16-75 years) currently were treated with insulin pump therapy. Participants were randomly assigned (1:1) to the INPUT program or to usual care using a computer-generated algorithm, with study center as the stratification factor. The primary outcome was HbA1c change from baseline to 6 months. Secondary outcomes were incidence of severe hypoglycemia and changes in behavioral and psychosocial measures. RESULTS: Between 1 April 2016 and 26 April 2016, 268 people with diabetes and a mean duration of CSII therapy of 9.5 years were randomly assigned to the INPUT group (n = 135) or control group (n = 133). At 6 months, HbA1c improved in the INPUT group (8.33 ± 0.8 vs. 8.04 ± 0.9; P < 0.0001) but not in the control group (8.33 ± 1.0 vs. 8.27 ± 1.0; P = 0.11). The between-group difference in HbA1c reduction was significant, favoring INPUT (-0.28% vs. -0.06%, Δ -0.22%, 95% CI -0.38 to -0.06; P = 0.0029). The incidence rate ratio of severe hypoglycemia was 3.55 times higher for participants in the control group than for those in the INPUT group (95% CI 1.50-8.43; P = 0.0041). CONCLUSIONS: The INPUT education program led to a significant improvement in glycemic control and incidence of severe hypoglycemia in insulin pump users.

High reported treatment satisfaction in people with type 1 diabetes switching to latest generation insulin pump regardless of previous therapy.

The effects of transition by individuals with type 1 diabetes (T1D) to more recently available continuous glucose monitoring (CGM)-enabled insulin pumps from either multiple daily insulin injections (MDI) or older insulin pumps on treatment satisfaction have not been well studied. We conducted a survey to assess treatment satisfaction among users of the Animas(®) Vibe™ insulin pump, a latest generation insulin pump (LGIP) system (CGM-enabled), after switching from MDI or earlier generation insulin pumps. Individuals with T1D from 141 centers in 5 countries and 4 language areas participated in the survey. Treatment satisfaction was assessed by the Insulin Treatment Satisfaction Questionnaire (ITSQ), which was included in a 50-item online questionnaire that also assessed preference for using the LGIP compared with previous treatment and satisfaction with key LGIP features. A total of 356 individuals, ages 12-79 years, responded to the survey: mean (SD) age 38.4 (16.1) years; diabetes duration 19.1 (13.3) years; female 59%; previously treated with MDI 58%. Overall mean (SD) ITSQ scores were high among all respondents regardless of prior treatment: 95.1 (23.2) (scale: 0-132). No differences between previous-treatment groups were seen. Most (83%) of respondents rated the LGIP to be better than their previous insulin delivery system: "much better" (65%), "a bit better" (18%) regardless of age, and 95% would recommend using the LGIP to others. Use of the Animas Vibe was associated with high treatment satisfaction and perceived as a better method of insulin delivery regardless of previous insulin therapy or age.

Achievement of guideline-defined treatment goals in primary care: the German Coronary Risk Management (CoRiMa) study.

AIMS: The success in achieving treatment goals for cardiovascular risk factors in primary care is largely unknown. Therefore, the goals of this study were (i) to assess whether routinely collected practice data can be used to evaluate treatment in primary care, (ii) to compare current treatment with goals of published guidelines, and (iii) to calculate future risk for cardiovascular events using these real-life data. METHODS AND RESULTS: In 110 physician offices in Germany, data from the patient management systems of all patients seen between January 1998 and June 2005 were extracted and analysed (715 644) with current guidelines used for reference. Of those patents, 284 096 (40% of all patients analysed) had one of the following diseases: 157 101 (55% of 284 096) had hypertension, 83 005 (29%) diabetes, 64 205 (23%) coronary artery disease (CAD), 174 787 (62%) hyperlipidaemia, and 136 360 (48%) had more than one of the listed diagnoses. During the last visit, treatment goals were achieved for total and LDL cholesterol in 9 and 29%, respectively, for blood pressure in 28%, and for HbA1c in 36%. Low achievement of treatment goals was also seen in patients with CAD or diabetes. Using the Framingham risk model and the SCORE Deutschland risk charts, 20 and 22% of patients had a high 10-year risk for a primary cardiovascular event and a fatal cardiovascular event, respectively. Achieving treatment goals for all risk factors would significantly reduce the number of high-risk patients. CONCLUSION: (i) Routinely collected practice data can be used to evaluate quality of care; (ii) 40% of patients in primary care have cardiovascular disease or diabetes; (iii) even in high-risk patients, the majority does not achieve treatment goals; and (iv) achieving the treatment goals would reduce the proportion of high-risk patients from 20 to <5%.