Benefits of Using the i-Port System on Insulin-Treated Patients

This prospective study was conducted at the Diabetes and Endocrine Center at Prince Mansour Military Hospital in Taif, Saudi Arabia. Patients with either type 1 or type 2 diabetes who had a routine visit to the Diabetes Educator Clinic from June 2015 to June 2016 were asked to participate. Data were collected through a formal interview with each patient. Participants gave verbal consent. Patients with gestational diabetes and those with existing psychiatric disorders were excluded.

The researchers obtained baseline characteristics and measurements for each participant. Laboratory data were collected from each patient’s electronic medical records. All patients were educated and trained to use the i-Port Advance injection port, which includes a built-in inserter and allows for quick and virtually painless application. Only a soft flexible tube called a cannula stays under the skin. Once the port is applied, patients inject themselves with an insulin pen through the port instead of through the skin (9).

Patients were identified by their names and medical record numbers. All patients were interviewed using a questionnaire to collect personal data and baseline characteristics. This questionnaire was tested with 10 patients before the data collection phase of the study to check for errors, ambiguities, and redundancies.

The participating patients’ satisfaction levels were assessed using the Arabic version of the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) (10). The DTSQs is an eight-item questionnaire that has been used in a number of clinical trials and in routine clinical practice to determine patient satisfaction with their diabetes medications. Each item was scored on a 6-point Likert scale. Scores on items 1, 4, 5, 6, 7, and 8 were summed to form a treatment satisfaction score ranging from 0 to 36. A score of 0 indicated the least satisfaction with treatment, with higher scores indicating greater satisfaction to a maximum satisfaction score of 36. Items 2 and 3 of the questionnaire were summed to form a glycemic control score ranging from 0 to 12. Each of these items is rated from 0 to indicate “none of the time” to 6 to indicate “most of the time,” with lower scores indicating blood glucose levels closer to a normal range (11).

Researchers followed up with all of the participants within a few weeks to a few months of their initial visit and asked about their i-Port use experience and duration. Participants were then divided into two groups: regular (continuous) users of the i-Port for ≥3 months (group A) and irregular (discontinuous) users (group B). Participants in both groups were asked to complete the DTSQs again and were asked about the duration of their use of the i-Port and the local complications they experienced during and after i-Port use. Any patient who reported missing an insulin injection for any cause was considered to be noncompliant.

Data were collected in an Excel spreadsheet (Microsoft Corp., Columbia, Md.) and analyzed using SPSS version 20 (IBM Corp., Chicago, Ill.). Means and SDs were used to present scale data, and frequency and percentages were used to present categorical data. The χ² test was used to assess the relationship between variables, and a t test was used to compare the means in the analysis. We considered P ≤0.05 to be statistically significant.

A total of 55 patients comprising 25 males and 30 females were included, and 92.7% of them were using an insulin pen. A majority were also patients with type 1 diabetes (92.7%). Although the mean duration of diabetes was 4.6 ± 4.25 years, the mean A1C was 9.54 ± 1.81%, with 45.5% reporting noncompliance with insulin doses. Most participants at baseline had had a diabetes-related hospitalization in the previous 3 months. Fear of needles accounted for only 9.1% of insulin noncompliance (Table 1).

At baseline, 27 patients were regular users of the i-Port, and 28 patients were irregular users. The mean duration of i-Port usage was 7.1 months (SD 3.6 months) among the regular users and 0.6 months (SD 0.35 months) among irregular users. At baseline, there was no statistically significant difference between the two groups regarding mean age (P = 0.812), sex (P = 0.549), type of diabetes (P = 0.681), or mean diabetes duration (P = 0.901). Moreover, mean A1C (P = 0.056), diabetes-related hospitalization in the previous 3 months (P = 0.189), mean number of hospitalizations (P = 0.976), and hypoglycemia frequency (P = 0.146) were not significantly different between groups.

At baseline, regular users were more likely to report noncompliance with insulin compared to irregular users, with a fear of needles being the main reason, but the difference was not statistically significant (P = 0.338 and P = 0.328, respectively). On the other hand, insulin self-injections by patients were higher among irregular users (48.1%) than regular users (25.9%) (P = 0.038). At baseline, the mean DTSQs scores were higher among irregular users (31.2%) than regular users (28.9%), whereas the mean glycemic control score was higher among regular users (7.3%) than irregular users (6.7%), but without statistical significance (P = 0.159 and P = 0.380, respectively) (Table 2).

We compared the characteristics of the regular users alone at baseline and at the end of the follow-up period. At the end of the follow-up period, there was a statistically significant decrease in the mean number of missed insulin doses (P = 0.032), patients were more likely to report compliance with insulin (P = 0.028), and the number of diabetes-related hospitalizations decreased (P <0.001). We found no statistically significant difference between baseline and the end of follow-up with regard to the DTSQs treatment satisfaction and glycemic control scores, although the mean A1C was lower at the end of follow-up than at baseline. Also, frequent hypoglycemia (weekly or more often) was higher at baseline than at the end of follow-up, but the difference was not statistically significant (Table 3). The most common local complication during and after the i-Port use was scarring (60%), and the least common was swelling at the i-Port site (5.5%) (Figure 1).

Our study mainly included young patients with short-duration type 1 diabetes who used insulin pens and were likely to report noncompliance with insulin and to have uncontrolled diabetes. The regular use of the i-Port resulted in a nonsignificant improvement of A1C and decrease in the frequency of the hypoglycemia. Compared to baseline, regular i-Port users at the end of the follow-up period were more likely to report compliance with insulin and to have fewer diabetes-related hospitalizations, which were statically significant differences.

For the whole cohort, only 36.4% of the patients reported self-injection of insulin at baseline. Regular users of i-Port at baseline were less likely than irregular users to report self-injecting, but at the end of the follow-up period, regular users were twice as likely to self-inject insulin and had a 0.73% improvement in A1C. This improvement was most likely due to psychosocial effects given that many of the patients at baseline reported fear of needles as a reason for noncompliance. Also, when compared to baseline, i-Port regular users at the end of the follow-up period were more likely to report compliance with insulin, which resulted in better metabolic control with fewer diabetes-related hospitalizations. Moreover, a previous study (12) showed that self-efficacy and care correlated with better glycemic control, and our study showed that regular i-Port users were more likely to report self-injecting insulin and had a slight improvement in their treatment satisfaction score.

At baseline, 50% of the regular users reported noncompliance with insulin, and 14.8% reported a fear of needles as the cause. At the end of follow-up, 11.1% reported noncompliance with insulin. This resulted in fewer diabetes-related hospitalizations among the regular users at the end of the follow-up period (7.4%) compared to baseline (59.3%). A previous study showed that poor insulin adherence is the main cause for recurrent hospitalizations for diabetes ketoacidosis (13).

Given the observed improvement in insulin compliance in our study and the recent advancements in glucose monitoring technology, we anticipate that patients will become more proactive with their glucose readings, which will ultimately improve their clinical and biochemical outcomes. However, a larger study would be needed to evaluate this.

Local complications at the site of the i-Port insertion were common, which may explain the small, nonsignificant improvement in treatment satisfaction despite the lower rates of hospitalization and hypoglycemia observed among regular i-Port users at the end of the follow-up period. Scarring at the site of i-Port usage was the most common side effect and was mainly due to skin irritation at the insertion site. Most of these occurrences were mild and self-limited and were completely resolved after changing the insertion site without any need for further evaluation.

The weaknesses of our study include its small sample size and short follow-up duration and the fact that it involved a single center. Its strengths include the prospective nature of the study and the novelty given the limited published data about i-Port usage. We recommend a larger prospective study for selected insulin-dependent patients who report poor adherence to insulin because of a fear of needles.

Patients in our study were mainly adolescents with poorly controlled type 1 diabetes, a majority of whom reported noncompliance with insulin and frequent diabetes-related hospitalizations. Regular i-Port usage improved compliance with insulin and self-care and resulted in lower rates of diabetes-related hospitalization and hypoglycemia, as well as a 0.73% reduction in A1C. Our study suggests that young patients with a shorter duration of diabetes for whom insulin is injected by a parent were more likely to benefit from using the i-Port Advance system.

No potential conflicts of interest relevant to this article were reported.

A.M.K. and K.A.A. contributed equally to this work in designing and carrying out the reported study, analyzing the data, and writing the article. K.A.A. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.