{'fraction_non_alphanumeric': 0.03182080369159777, 'fraction_numerical': 0.012209190540280716, 'mean_word_length': 5.115814226925338, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 1, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
Improving Self-Monitoring of Blood Glucose among Adults with Type 1 Diabetes: Results of the Mobile™ Study

Introduction The objective of this study was to determine whether people with type 1 diabetes are more likely to self-monitor their blood glucose (SMBG) as recommended by their diabetes health care professional using the Accu-Chek Mobile™ (F. Hoffmann-La Roche AG, Basel, Switzerland) monitoring system compared to the Freestyle Optium™ (Abbott, North Chicago, IL, USA). Methods Thirty-five participants with type 1 diabetes participating in a randomized cross-over study were assigned to monitor their blood glucose levels for a 3-month period using the Accu-Chek Mobile or the Freestyle Optium monitoring system and then to cross-over to the alternative device. After completion of the 6-month cross-over period, participants were invited to select their meter of choice and were followed for a further 3 months. Results SMBG frequency increased in both groups but participants monitored significantly more often using the Accu-Chek Mobile meter (frequency SMBG/week median: 19 vs. 10, P = 0.04). After 3 months using each meter, 77% of participants indicated a preference for the Accu-Chek Mobile meter. Monitoring frequency in this group remained higher than baseline during the 3-month post-cross-over follow-up period. Conclusion Our results indicate that the Accu-Chek Mobile meter improves SMBG frequency. After experience of both systems, Accu-Chek Mobile was the meter of choice for the majority of participants in this study. Funding Roche Diabetes Care Unconditional Education Grant. Electronic supplementary material The online version of this article (doi:10.1007/s13300-014-0092-9) contains supplementary material, which is available to authorized users.


INTRODUCTION
The findings of the Diabetes Control and Complications Trial (DCCT) and Epidemiology of Diabetes Interventions and Complications (EDIC) studies have highlighted the importance of maintaining glycemic control as close to target as possible in people with type 1 diabetes [1,2]. However, such optimization is often difficult to achieve. While intensive treatment of type 1 diabetes has been made possible by combining multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) with frequent self-monitoring of blood glucose (SMBG), many people with type 1 diabetes only measure pre-meal blood glucose levels, making decisions regarding insulin therapy optimization difficult.
There are a number of reasons why people with type 1 diabetes monitor less frequently than recommended. For example, forgetfulness, difficulties with handling and disposing of test strips, lifestyle alignment (embarrassment of monitoring in public, lack of time, and difficulty monitoring away from home), as well as the inability to make decisions based on the results, have all been identified as major barriers to appropriate SMBG [3][4][5]. To address these issues, a novel, strip-free blood glucose monitoring system has been developed, the Accu-Chek Mobile TM

Study Design
This was a two-center, prospective, randomized After signing informed consent, subjects were randomly assigned to one of two possible monitoring sequences: (1) use of the Accu-Chek Mobile system during the first 3 months of the study, crossing over to use the Freestyle Optium system during the second 3 months of the study or, (2) use of the Freestyle Optium system during the first 3 months, crossing over to use the Accu-Chek Mobile system during the second 3 months of the study. The primary outcome of the study was frequency of SMBG per week. Secondary outcomes included glycemic control, satisfaction with treatment, confidence in treating diabetes, and diabetes distress, as well as meter preference.
Participants were required to attend three study visits: baseline (Visit 1), 3 months (Visit 2), and 6 months (Visit 3). Where possible, clinic and research visits were aligned to minimize the participant's attendance to the study sites. At Visits 1 and 2 (baseline and 3 months) the participants were instructed on the use of their assigned meter and they were provided with sufficient supplies to monitor their blood glucose levels up to eight times a day for the following 3 months.
From Visit 2 onwards, the participant's blood glucose monitoring system (Accu-Chek Mobile or Freestyle Optium) memory was downloaded for assessment of monitoring frequency. The memory capacity of each system is 500 and 450 measurements, respectively. Monitoring frequency was calculated as (number of results on the study meter/days of memory) 9 7.
Glycemic control was assessed using HbA1c.
HbA1c measured at the closest clinical appointment was recorded at each study visit.
If the HbA1c had been measured more than 2 weeks prior to study visit, a finger prick sample of blood was collected and an HbA1c estimation was performed using a point of care device (DCA Vantage Ò Analyzer, Siemens AG, Germany). Participants also completed a series of validated questionnaires at enrolment. These included the Diabetes Treatment Satisfaction Questionnaire (DTSQ), status and change measures (used under license) [4,5], the Confidence in Diabetes Self-Care (CIDS) scale [8], and the Problem Areas in Diabetes Management (PAID) scale [9]. At the completion of the cross-over study participants were asked to select their study meter of choice. They were also invited to participate in a 3-month extension study.
Participants who chose to be involved in this extension study were provided with sufficient supplies to monitor their blood glucose levels up to eight times a day for the following 3 months using their preferred meter. They attended a fourth study visit scheduled 9 months after their baseline visit and further outcome data were collected as described above.

Data Analysis and Sample Size
The primary outcome was change in frequency of monitoring from baseline. Using a two-sided one-sample t test (a = 0.05), and assuming a

RESULTS
Forty people with type 1 diabetes were recruited for the study; of these, five were lost to followup. As shown in Table 1, the participants who were lost to follow-up were younger than their counterparts who completed the study. There were no other differences in baseline profiles.
Monitoring frequency increased during both of the 3-month cross-over periods but participants monitored significantly more often during the 3 months they were randomized to use the Accu-Chek Mobile meter ( alone, low diabetes-related concern, and cigarette smoking [10]. High frequency of monitoring has been associated with lower HbA1c and reduced incidence of hypoglycemia, although in some studies recent hypoglycemia was associated with increased monitoring frequency [10][11][12]. In a study by Schütt et al. [12], HbA1c was reduced by 0.32% per extra test done per day in people with type 1 diabetes on 4 injections per day or CSII, similar to the participants in our study. One study has related SMBG to long-term complications and has suggested that higher frequencies of monitoring are associated with reduced HbA1c variability and reduced microvascular complications [13].
Other barriers to SMBG include invasiveness.
In a study examining the impact of the person's perception of the invasiveness of the SMBG technique [14], 63% of respondents reported invasiveness was a reason for skipping tests. A semi-quantitative measure of perceived invasiveness correlated negatively with testing frequency [14]. Although there are no published data, the authors were of the opinion that this invasiveness extends beyond the lancet but includes the degree to which the SMBG technique and equipment impact on lifestyle and cause embarrassment through being socially visible. The Accu-Chek Mobile system used in this study has potential advantages in having a connected lancet device and a stripless system utilizing a flexible strip contained within a cartridge. These features make the device potentially simpler to use and removed the need to deal with waste strips. Our  [3]; this was, however, an uncontrolled and non-randomized study.
We designed a study to examine the effect of two blood glucose monitoring systems on SHBM frequency in a prospective, randomized cross-over study. The primary outcome of the study was the number of SMBG estimations per week. Secondary outcomes included glycemic control, satisfaction with treatment, confidence in treating diabetes, and diabetes distress. Meter preference was assessed at the end of the 6-month cross-over study by allowing the subjects to choose the meter they would use for the final 3 months of the study. The advantages of the design were that subjects were able to experience each of the meters in turn and then express a preference, while the cross-over design ensured that any effect for the order of exposure was controlled for by the randomization. Table 2 Monitoring frequency (SMBG/week), glycemic control (HbA1c), satisfaction with treatment (DTSQ), confidence in treating diabetes (CIDS score), and diabetes distress (PAID score) at baseline and during the 3-month cross-over periods that participants were randomized to use the Accu-Chek Mobile TM  CIDS confidence in diabetes self-care scale, DTSQs diabetes treatment satisfaction questionnaire (status version), DTSQc diabetes treatment satisfaction questionnaire (change version), HbA1c glycosylated hemoglobin, PAID problem areas in diabetes management, SMBG self-monitoring of blood glucose Results expressed as mean (SD) or a median (IQR) b F = 6.2, P = 0.003 Our results indicated that, while all subjects increased their monitoring frequency, persons using the Accu-Chek Mobile system tested more frequently than those using the Freestyle Optium system, and that the majority of patients preferred the Accu-Chek Mobile system. There was no effect of SMBG system on satisfaction and confidence in diabetes treatment or in diabetes-related distress. It is likely, therefore, that the change in SMBG frequency was due to ease of use of the device rather than any change in attitude or more general compliance within the cohort. Open Access. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.