Despite the prevalent use of insulin pump therapy worldwide, few studies have been conducted among young patients with type 1 diabetes (T1D) in Korea. We investigated the durability and effectiveness of insulin pump therapy among Korean pediatric and young adult patients with T1D.
This study included 54 patients with T1D diagnosed at pediatric ages (range, 1.1–14.1 years) who initiated insulin pump therapy during 2016–2019 at Seoul National University Children's Hospital and Seoul National University Bundang Hospital. Clinical and biochemical data, including anthropometric measurements, insulin dose, and glycated hemoglobin (HbA1c) levels were obtained from T1D diagnosis to last follow-up.
Forty-four patients (81.5%) continued insulin pump therapy with a median pump use duration of 2.9 years (range, 0.2–3.5 years); 10 discontinued the therapy within 12 months (<1 month, n=6; 1–6 months, n=1; and 6–12 months, n=3) due to physical interferences or financial problems. Older age (≥10 years of age) and longer diabetes duration (≥2 years) at the initiation of pump therapy were associated with discontinuation (
Insulin pump therapy was effective in improving glycemic control in T1D patients during 12 months of treatment. Early initiation of insulin pump therapy after T1D diagnosis was helpful for continuing therapy.
Type 1 diabetes (T1D) is a chronic disease caused by the autoimmune destruction of pancreatic beta cells and insulin deficiency. The treatment goal for T1D is to maintain target glucose levels to prevent microvascular and cardiovascular complications [
Regarding these goals, T1D management has been significantly improved with the progress of continuous glucose monitoring (CGM) systems and insulin pumps [
While the use of insulin pumps has expanded, there is still variability depending on the region [
This retrospective study included 54 patients with T1D diagnosed at pediatric ages (range, 1.1–14.1 years), who initiated insulin pump therapy with SAPs between August 2016 and November 2019 at the Seoul National University Children's Hospital (n=47) and Seoul National University Bundang Hospital (n=7). In May 2016, the use of SAP devices (Minimed 640G; Medtronic, Northridge, CA, USA) was approved by the Korean Ministry of Food and Drug Safety [
Data on demographic characteristics, anthropometric measurements, SES, and factors affecting diabetes management from T1D diagnosis to last follow-up were obtained from medical records. Height (cm) was measured using a Harpenden stadiometer (Holtain Ltd., Crymych, Wales, UK), and weight was measured using a digital scale (150 A; Cas Co., Ltd., Seoul, Korea). Body mass index (BMI) was calculated as weight divided by height in meters squared (kg/m2). The height, weight, and BMI
The decision to initiate insulin pump therapy was made based on clinical grounds and the preferences of the patients and their families. The majority of patients (n=47) initiated insulin pump therapy through a 4-day inpatient program, which consisted of the implantation of the device, monitoring of glucose levels, and educational training. The remaining patients (n=7) started insulin pump therapy through an outpatient educational program. Both programs offered structured education by diabetes specialist nurses and dietitians, who demonstrated the basic principles of insulin pump therapy and the CGM system, initial pump settings (basal rate, insulin-to-carbohydrate ratio, and insulin sensitivity factor), basal rate adjustment, insulin bolus options, interpretation and calibration of the CGM, infusion set management, and the potential complications of pump or infusion set failure (mainly DKA). All patients were instructed to change the infusion set every 3 days. Because Medtronic Korea offered a 1-month free trial of the MiniMed 640G to T1D patients, they were able to decide whether to purchase the device and continue with the therapy after the trial. Patients who decided not to use the insulin pump returned to their previous insulin therapies.
Statistical analyses were performed using the IBM SPSS Statistics ver. 25.0, (IBM Corp., Armonk, NY, USA). All continuous variables are presented as median values with interquartile ranges, and the Mann-Whitney
Among the 54 patients, 44 (81.5%) continued insulin pump therapy throughout the study, with a median duration of insulin pump use of 2.9 years (range, 0.2–3.5 years). Among them, 2 patients switched from SAP to conventional insulin pump therapy (Dana Diabecare R, Sooil) after the 1-month trial. Forty-one (93.2%) used insulin pumps provided with real-time CGM; 3 patients refused to use the CGM due to skin reactions (n=2) or financial constraints (n=1). The other 10 patients (18.5%) discontinued the insulin pump therapy and decided to return to MDI therapy, with a median time of pump use of 0.1 years (range, 0.0–1.0 years).
No differences were observed between the 2 groups in terms of sex ratio, mean age at diagnosis, prior insulin regimen, CGM device use, or episodes of DKA prior to pump therapy initiation (
Ten patients discontinued the insulin pump therapy within 12 months (<1 month, n=6; 1–6 months, n=1; and 6–12 months, n=3) (
We compared the BMI
After 1 year of insulin pump therapy, the HbA1c level improved in 25 patients (80.6%), and the median HbA1c level decreased significantly from 8.9% to 8.1% (
Four episodes of DKA occurred in 4 patients during insulin pump therapy in this cohort (
To the best of our knowledge, this is the first study reporting the clinical outcomes of insulin pump therapy among pediatric and young adult patients with T1D in Korea. In this study, 81.5% of the patients continually received pump therapy, with a median duration of pump use of 2.9 years. Those who discontinued pump therapy were older and had a longer duration of diabetes at the initiation of pump therapy. Most patients discontinued treatment within a year due to physical discomfort or financial problems. Improved glycemic control without a significant increase in BMI
Although more than 80% of our patients continually received pump therapy, the discontinuation rate in this study was higher (18.5%) than that observed in previous studies [
We found that older patients and those with longer diabetes duration were more likely to discontinue pump therapy, similar to the results in previous studies [
The most common cause of discontinuation was physical problems, including skin reactions or interference with physical activity, which is similar to the results in previous studies [
After 1 year of insulin pump therapy, the HbA1c levels of the participants in the continuation group decreased significantly by 0.8%. Based on previous meta-analyses [
Four patients presented with DKA during the pump therapy, which was associated with poor adherence to therapy. Although DKA had been considered more common among users of pumps based on older technologies [
This study had several limitations. It had a retrospective design, a small number of patients, and a short follow-up duration, which limited the statistical power to show significant changes in BMI
In conclusion, insulin pump therapy was a durable and effective means of insulin treatment among patients with T1D in Korea. More than 80% of patients continually received insulin pump therapy, with significant improvements in HbA1c levels after 1 year of treatment. Patients in the discontinuation group were older and had a longer diabetes duration at pump initiation, indicating the need for an early introduction and ongoing education about insulin pump therapy. Further larger follow-up studies are needed to determine the long-term effects of insulin pump therapy use among patients with T1D in Korea.
This study protocol was reviewed and approved by the Institutional Review Boards (IRBs) of Seoul National University Hospital (IRB number: H-2002-156-1105) and Seoul National University Bundang Hospital (IRB number: B-2004-604-401) with waiver of informed consent.
No potential conflict of interest relevant to this article was reported.
Supplementary Fig. 1 can be found via
Clinical characteristics of the patients at pump therapy initiation
Characteristic | Overall (n=54) | Continued pump therapy (n=44) | Discontinued pump therapy (n=10) | |
---|---|---|---|---|
Male sex | 25 (46.3) | 19 (43.2) | 6 (60.0) | 0.541 |
Age at diagnosis (yr) | 7.4 (3.7–10.1) | 6.9 (4.7–8.4) | 7.7 (3.6–10.5) | 0.511 |
Insulin regimen prior to pump therapy | 0.173 | |||
Twice-daily injection | 8 (14.8) | 8 (18.2) | 0 (0) | |
Multiple daily injection | 42 (77.8) | 32 (72.7) | 10 (100) | |
Use of insulin pump from the diagnosis | 4 (7.4) | 4 (9.1) | 0 (0) | |
Use of CGM device prior to pump therapy | 10 (18.5) | 9 (20.1) | 1 (10.0) | 0.751 |
Occurrence of DKA in a year prior to pump therapy initiation | 2 (3.7) | 2 (4.5) | 0 (0) | 1.000 |
Age at pump therapy initiation (yr) | 12.0 (8.6–14.8) | 12.6 (12.0–14.8) | 13.8 (6.9–14.7) | 0.166 |
<10 years old | 16 (29.6) | 16 (36.4) | 0 (0) | 0.024 |
≥10 years old | 38 (70.4) | 28 (63.6) | 10 (100) | |
Duration of diabetes at pump therapy initiation (yr) | 3.7 (1.5–6.6) | 2.6 (1.0–6.2) | 6.8 (4.9–9.9) | 0.009 |
<2 years | 20 (37.0) | 20 (45.5) | 0 (0) | 0.020 |
≥2 years | 34 (63.0) | 24 (54.5) | 10 (100) | |
Pubertal status at pump therapy initiation | 0.601 | |||
Prepubertal | 18 (33.3) | 16 (36.4) | 2 (20.2) | |
Tanner 2–4 | 17 (31.5) | 13 (29.5) | 4 (40.0) | |
Tanner 5 | 19 (35.2) | 15 (34.1) | 4 (40.0) | |
Body mass index |
0.26 (-0.73 to 0.92) | 0.24 (-0.74 to 0.87) | 0.29 (-0.25 to 0.94) | 0.556 |
HbA1c (%) at pump therapy initiation | 8.7 (7.6–9.7) | 8.7 (7.6–9.6) | 8.8 (8.0–9.7) | 0.785 |
Total daily insulin dose (U/kg/day) at pump therapy initiation | 0.78 (0.64–1.01) | 0.77 (0.62–1.00) | 0.94 (0.79–1.21) | 0.034 |
Inpatient education for insulin pump | 47 (87.0) | 39 (88.6) | 8 (80.0) | 0.385 |
Coexisting disease | 6 (11.1) | 5 (11.4) | 1 (10.0) | 0.985 |
Health insurance type | 0.687 | |||
National Health Insurance | 43 (79.6) | 36 (81.8) | 7 (70.0) | |
Medical Aid | 11 (20.4) | 8 (18.2) | 3 (30.0) |
Values are presented as number (%) or median (interquartile range).
DKA, diabetic ketoacidosis; CGM, continuous glucose monitoring; HbA1c, glycated hemoglobin.
Timing and reasons for discontinuation of insulin pump therapy
Variable | No. of patients (%) |
---|---|
Timing of discontinuation | |
Before 1 month (nonpurchase) | 6 (60.0) |
Between 1 and 6 months | 1 (10.0) |
Between 6 and 12 months | 3 (30.0) |
Reasons for discontinuation | |
Physical problem | 5 (50.0) |
Skin reactions at the insertion site and/or due to adhesive | 3 |
Interference with sports and physical activities | 2 |
Financial constraints | 3 (30.0) |
Dislike of the pump | 2 (20.0) |
Metabolic outcomes after 1 year of insulin pump therapy initiation
Metabolic outcomes | Continued pump therapy over 1 year group (n=31) |
Discontinued pump therapy group (n=10) |
|||||
---|---|---|---|---|---|---|---|
At the initiation of pump therapy | 1 Year after pump therapy initiation | At the initiation of pump therapy | 1 Year after pump therapy initiation | ||||
BMI |
0.33 (-0.62 to 0.81) | 0.16 (-0.31 to 1.24) | 0.315 | 0.29 (-0.25 to 0.94) | 0.83 (-0.29 to 1.08) | 0.646 | 0.962 |
HbA1c (%) | 8.9 (8.0–10.1) | 8.1 (7.4–9.2) | <0.001 | 8.8 (8.0–9.7) | 9.0 (8.3–9.9) | 0.610 | 0.014 |
TDD (U/kg/day) | 0.81 (0.69–1.03) | 1.00 (0.81–1.14) | 0.057 | 0.94 (0.79–1.21) | 1.24 (1.11–1.29) | 0.068 | 0.347 |
Values are presented as median (interquartile range).
BMI, body mass index; HbA1c, glycated hemoglobin; TDD, total daily dose of insulin.
Among 38 patients who continued pump therapy over 1 year, 7 patients with diabetes duration <1 year at the time of insulin pump initiation were excluded.
Patients who developed diabetic ketoacidosis during insulin pump therapy
No. | Sex | At the time of diabetic ketoacidosis (DKA) episode |
||||
---|---|---|---|---|---|---|
Age (yr) | Diabetes duration (yr) | Duration of insulin pump therapy (yr) | Degree of DKA | Reasons for DKA | ||
1 | F | 9.9 | 2.6 | 0.7 | Severe | Infusion set failure+gastroenteritis |
2 | F | 12.8 | 11.6 | 1.4 | N/A |
Missing bolus |
3 | F | 16.0 | 2.5 | 0.6 | Moderate | Missing bolus |
4 | F | 20.1 | 10.5 | 1.0 | Severe | Infusion set failure+alcohol consumption |
N/A, not available.
The patient was admitted to another hospital during the DKA episode, and biochemical variables at hospital admission were not available.