Routine Sensor-Augmented Pump Therapy in Type 1 Diabetes: The INTERPRET Study

Abstract

Background: Sensor-augmented pump (SAP) therapy can improve glycemic control, compared with multiple daily insulin injections or with insulin pump therapy alone, without increasing the risk of hypoglycemia. Subjects and Methods: A 12-month observational study in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII), upon the introduction of continuous glucose monitoring (CGM), was conducted in 15 countries (in Europe and in Israel) to document the real-life use of SAP and assess which variables are associated with improvement in type 1 diabetes management. Results: Data from 263 patients (38% male; mean age, 28.0 -15.7 years [range, 1-69 years]; body mass index, 23.3 -4.9 kg/m 2 ; diabetes duration, 13.9 -10.7 years; CSII duration, 2.6 -3 years) were collected. Baseline mean glycated hemoglobin A1c (HbA 1c ) was 8.1 -1.4%; 82% had suboptimal HbA 1c ( ‡ 7%). The average sensor use for 12 months was 30% (range, 0-94%), and sensor use decreased with time (first 3 months, 37%; last 3 months, 27%). Factors associated with improvement in HbA 1c after 12 months in patients with baseline HbA 1c ‡ 7% were high baseline HbA 1c (P < 0.001), older age group (P < 0.001), and more frequent sensor use (P = 0.047). Significantly less hospitalization, increased treatment satisfaction, and reduced fear of hypoglycemia were reported after 12 months of SAP. Conclusions: This is the largest and longest multicenter prospective observational study providing real-life data on SAP. These results are consistent with those of controlled trials showing the effectiveness of CGM in pump users.

MD-Logic Overnight Control for 6 Weeks of Home Use in Patients With Type 1 Diabetes: Randomized Crossover Trial

“…The advanced technology of SAP therapy demands almost unremitting attention by patients and caregivers (23) and is still being used only by a small number of patients (24,25). Many of those who did begin to use it subsequently discontinued its use (26,27), mainly because of the intense effort and decision making involved, fraught with tension and anxiety. This is particularly true for the pediatric age-group and adolescents, who often lack compliance in treating their diabetes (26).…”

Diabetes Technology

“…32 A 12-month, multicenter international study of SAP for adults with T1D demonstrated that while participants on average used the sensor less over the course of the trial (average use = 30%), those who stayed with SAP had fewer hospitalizations by 12 months. 33 More recent studies have also found that SAP has led to improvement in A1C as well as a decrease in time spent in hypoglycemia. [34][35][36] The STAR 3 trial showed that A1C decreases were similar across adult and pediatric patients 32 and the combined benefit of SAP was greater than that of using pump or CGM alone.…”

“…12 For SAP, a low A1C, and frequency of use of the sensor predicts more frequent long-term use. 33 Thus far in the literature, there have been no differences across age, gender, duration of diabetes, duration of pump therapy, complications, or insurance reasons in predicting continuation of CGM use. 33 …”

Objectives and methods of the ORCHESTRA FOUNDATION Registry study: a multicenter observational study of the use of insulin pump therapy in pregnant women with type 1 diabetes mellitus in Poland.

“…Insulin pump therapy has been shown to improve quality of life in pregnant women with diabetes [31,41]. The Orchestra Foundation facilitated use of insulin pumps by all pregnant women with type 1 diabetes in Poland; hence, all participants fulfilling study inclusion criteria were registered, and only those with contraindications to insulin pump therapy were excluded from the study.…”

“…Both CSII and continuous glucose monitoring (CGM), alone or in combination as a sensor-augmented pump (SAP) or sensor-integrated pump (SIP) therapy, improve glycemic control by reducing HbA 1c from 0.4-1.2% [24][25][26][27][28][29][30]. The recent INTERPRET study, the largest and longest multicenter prospective study to date, has confirmed the effectiveness of CGM in pump users; data from 263 patients using SAP therapy under real-life conditions over 12 months revealed significantly lower rates of hospitalization, greater treatment satisfaction, and reduced fear of hypoglycemia compared to CGM nonusers [31]. Other studies have also shown that the use of CGM and related features such as alarms and automatic insulin suspension (i.e., low glucose suspension [LGS]) reduces fear of hypoglycemia, the incidence of severe hypoglycemic events, and time spent in hypoglycemia [32][33][34][35].…”