A Clinical Trial of Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Older Adults With Type 2 Diabetes

Abstract

OBJECTIVE -To compare the efficacy and safety of continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) in older adults with insulin-treated type 2 diabetes and to assess treatment satisfaction and quality of life.RESEARCH DESIGN AND METHODS -Adults (n ϭ 107) Ն60 years of age (mean age 66 years) with insulin-treated type 2 diabetes (mean duration 16 years, BMI 32 kg/m 2 , and HbA 1C [A1C] 8.2%) were randomized to CSII (using insulin lispro) or MDI (using insulin lispro and insulin glargine) in a two-center, 12-month, prospective, randomized, controlled clinical trial. Efficacy was assessed with A1C, safety by frequency of hypoglycemia, and treatment satisfaction and quality of life with the Diabetes Quality of Life Clinical Trial Questionnaire and the 36-item short-form health survey, version 2.RESULTS -Forty-eight CSII subjects (91%) and 50 MDI subjects (93%) completed the study. Mean A1C fell by 1.7 Ϯ 1.0% in the CSII group to 6.6% and by 1.6 Ϯ 1.2% in the MDI group to 6.4%. The difference in A1C between treatment groups was not statistically significant (P ϭ 0.20). Eighty-one percent of CSII subjects and 90% of MDI subjects experienced at least one episode of minor (self-treated) hypoglycemia (P ϭ 0.17), and three CSII and six MDI subjects experienced severe hypoglycemia (P ϭ 0.49). Rates of severe hypoglycemia were similarly low in the two groups (CSII 0.08 and MDI 0.23 events per person-year, P ϭ 0.61). Weight gain did not differ between groups (P ϭ 0.70). Treatment satisfaction improved significantly with both CSII and MDI (P Ͻ 0.0001), and the difference between groups was not statistically significant (P ϭ 0.58).CONCLUSIONS -In older subjects with insulin-treated type 2 diabetes, both CSII and MDI achieved excellent glycemic control with good safety and patient satisfaction. Diabetes Care 28:1568 -1573, 2005I n the U.S., Ͼ20% of adults Ͼ65 years of age have diabetes (1). The risk of micro-and macrovascular complications increases in elderly patients with diabetes and is associated with higher hemoglobin HbA 1C (A1C) and longer duration of diabetes (2). In middle-aged adults with type 2 diabetes, intensive glycemic management can delay or prevent the development of microvascular and neuropathic complications (3,4). While the benefits of glycemic management are less clearly established in older adults, both the American Diabetes Association and the American Geriatrics Society recommend that older adults with good functional status maintain A1C levels Ͻ7% (5,6). Despite these recommendations, surveys have shown that only onethird of diabetic patients 65-74 years of age had A1C levels Ͻ7%. Of those using insulin, only 27% had A1C levels Ͻ7%, whereas nearly half had A1Cs Ͼ8% (7).While lifestyle changes and oral antidiabetes medications can improve glycemic control early in the course of type 2 diabetes, insulin is often required to reach A1C goals later in the course of disease. Intensive insulin therapy regimens employ either continuous subcutaneous insulin infusion (CSII) or mul...

Impact of clinical pharmacist collaboration in patients beginning insulin pump therapy: a retrospective and cross-sectional analysis

“…Several studies have previously evaluated the use of CSII in patients with diabetes2–9,22. Outcomes from most investigations directly comparing CSII vs MDI have demonstrated an overall reduction in HbA1c with CSII between the two methods6,8,22. Outcomes from transitional studies include improved glycemic control after switching from MDI to CSII3–5,7.…”

“…Outcomes from transitional studies include improved glycemic control after switching from MDI to CSII3–5,7. Further results from studies demonstrate that, while CSII therapy has improved glycemic control, there has not been a causative increase in minor or severe hypoglycemia events which is an important patient safety concern4,6. Finally, CSII-based therapy has resulted in a reduction in albumin excretion rates22 and improved patient quality-of-life9.…”

Continuous subcutaneous insulin infusion versus multiple daily insulin injections in patients with diabetes mellitus: systematic review and meta-analysis

“…For studies with crossover design the SMD in glycated haemoglobin was −0.4 (95% CI: −0.68, −0.07; I 2 =52%), corresponding to −0.4% in original units. For Patients with type 2 diabetes mellitus In both trials [44,45] no significant differences in HbA 1c between the two treatment groups were found at the end of the study (Table 1).…”

“…In the end, 33 publications with usable information were included in our systematic review. Of these, 17 studies (27 publications ) included mainly adult type 1 diabetic patients, three trials (four publications [40][41][42][43]) only children of up to 18 years and two studies (two publications [44,45]) examined patients with type 2 diabetes mellitus only.…”

“…Patients with type 2 diabetes mellitus Both studies had an open-label parallel study design [44,45] and 234 patients took part in the randomised controlled trials. The study periods were 24 and 52 weeks, respectively.…”