Comparative study of glycemic control and treatment satisfaction for patients with type 1 diabetes on sensor augmented insulin pump, insulin pump and multiple daily insulin injection: cross sectional study
Автор: Alshahrani A.A., Almutairi F.S.
Журнал: Cardiometry @cardiometry
Рубрика: Original research
Статья в выпуске: 30, 2024 года.
Бесплатный доступ
BACKGROUND: All patients with T1DM are on life-long insulin injection . However, since last decades with evolving diabetes technology ,there is a paucity of research on glycemic and self satisfaction effectiveness of new insulin pump and CGM devices in Saudi Arabia population whom they have different lifestyle and race. PATIENTS AND METHODS: A cross-sectional study was con-ducted at King Abdulaziz Medical City Endocrine Center in Ri-yadh, Saudi Arabia. The study focused on a sample of patients with type 1 diabetes aged 14 years and above using either a sensor-augmented insulin pump (Medtronic MiniMed 640G, 740G), insulin pump without a sensor (Medtronic Paradigm VEO 754), or multiple daily insulin injections for at least 6 months.
Type 1 diabetes, insulin pump, multiple daily insulin, satisfaction, glycemic control
Короткий адрес: https://sciup.org/148328271
IDR: 148328271 | DOI: 10.18137/cardiometry.2024.30.6272
Текст научной статьи Comparative study of glycemic control and treatment satisfaction for patients with type 1 diabetes on sensor augmented insulin pump, insulin pump and multiple daily insulin injection: cross sectional study
Ali A. Alshahrani, Fajr S. Almutairi. Comparative study of glycemic control and treatment satisfaction for patients with type 1 diabetes on sensor augmented insulin pump, insulin pump and multiple daily insulin injection: Cross sectional study. Cardiometry; Issue No. 30; February 2024; p. 62-72; DOI: 10.18137/cardiometry.2024.30.6272; Available from:
Background
Type 1 diabetes mellitus (T1DM) is a chronic disease characterized by insulin deficiency due to the absence of pancreatic β-cell, which leads to hyper- glycemia.1-4 Unfortunately, T1DM is common among children and adolescents worldwide and is often associated with serious acute and chronic complications.5
In a large multi-cohort study in Finland, individuals with type 1 diabetes have experienced a significant improvement in life expectancy in the past few decades. Despite this progress, their life expectancy remains 9.9 years lower than the general population.6All patients with type 1 diabetes require life-long insulin injection treatment.7In the last decade, new approaches such as insulin pumps, sensor-augmented insulin pumps, and hybrid closed-loop pumps have been introduced into management of type 1 diabetes.4,6
Intensive glycemic control is beneficial in reducing the incidence of microvascular and macrovascular complications in patients with type 1 diabetes.4Despite this, many patients still develop these complications. Clinical trials have shown that SAIP leads to rapid and sustained improvement in glycated hemoglobin (HbA1c) levels.8Clinical trials have also investigated the effectiveness of SAIP therapy in treating T1DM, where patients on multiple daily insulin injections were randomized to receive either SAIP or optimized multiple daily insulin injections therapy. At the end of the first follow-up year, the baseline HbA1c had decreased to 8.1% in the group on multiple daily insulin injections, while it decreased to 7.5% in the group on the SAIP group(P<0.001).9In the subsequent six optional months, patients in the SAIP group were allowed to continue with the treatment, while those in the multiple daily insulin injections group were allowed to switch to SAIP therapy. The results indicated that the sustained HbA1c levels in the group on SAIP therapy lasted for 18months, while those on multiple daily insulin injections transferred to SAIP therapy for 6 months experienced a significant reduction in sustained HbA1c levels compared with the 12-month value.10However, since last decades with evolving diabetes technology , there is a paucity of research on glycemic and self satisfaction effectiveness of new insulin pump and CGM devices in Saudi Arabia population whom they have different lifestyle and race.
PATIENTS AND METHODS
The study was conducted at King Abdulaziz Medical City Endocrine and Diabetes Center in Riyadh.Pa-tient readiness and other clinical eligibility factors determine the type of insulin modality patients with type 1 diabetes use in the Diabetes Center.To be included in the study, patients must be adults and adolescents aged 14years and older and should be on either a sensor-augmented insulin pump (insulin pump Medtronic MiniMed 640G, 740G suspend on low and pre-low) with Guardian Connect Sensor 7 or librae 2 , insulin pump without a sensor (Medtronic Paradigm VEO 754) or multiple daily insulin injections for at least 6 months. Those excluded from the study were patients with cognitive impairment, those on oral hypoglycemic agents except those given metformin for other clinical indications like PCOS ..etc , patients with a psychiatric diagnosis or on psychiatric medications, and those less than 14years of age. Patients on multiple daily insulin using sensor continuous glucose monitoring devices with real-time glucose alarms and those on hybrid closed-loop pumps were also excluded from the study.Adults patients and guardians were asked to fill out a self-administered questionnaire electronically using Google form.The questionnaire was designed to collect data on demographic and habitual characteristics such as age, sex, educational level, occupation, marital status, residence, smoking, and body mass index. Additionally, we recorded diabetes-related information such as duration of diabetes, co-morbid diseases like hypertension, cardiac conditions, ischemic heart diseases, dyslipidemia, thyroid problems, and other endocrine diseases, having diabetic complications like retinopathy, nephropathy, neuropathy, and diabetic foot.
Based on the information from Google electronic sheets, we collected the patient’s last HbA1c in the previous 3 months, the number of visits to a diabetic educator since diagnosis, and the number of diabetic ketoacidosis admissions during the last year. Moreover, we designed the Arabic version of the Diabetes Treatment Satisfaction Questionnaire (DTSQs) to assess patients` satisfaction with type 1 diabetes treat-ment,11the same as the original validated DTSQs paper sheet. This questionnaire is useful for comparing patients’ satisfaction levels using various treatment strategies. The DTSQs includes 8 health concepts, with 6 questions addressing general satisfaction with a score ranging from 0 (very dissatisfied) to 6 (very satisfied). The remaining two questions assessed hypoglycemic and hyperglycemic events, with a scale from 0 (never experienced) to 6 (most of the time). The total score is a sum of the six separate item scores. The higher the score, the higher the patient’s satisfaction.11
We have obtained approval from the Institutional review Board of the King Abdullah International
Medical Research Center , reference No. RC20/120/R , which was carried out according to the principles of Helsinki.Additionally, we have obtained written permission from the Director of the Endocrine and Diabetes Center, King Abdulaziz Medical City in Riyadh City. All adult participants and guardians provided written consent voluntarily to participate in the study. Data was treated confidentially and used only for research.
Data presented in the study were summarized using mean± standard deviation for quantitative continuous variables, while frequency and percentage were used for qualitative variables. Differences were tested using Chi-square (χ2) tests for categorical variables or oneway analysis of variance (ANOVA) tests to compare more than two groups. If a significant ANOVA test was observed, post hoc Tukey’s test was conducted to compare continuous variables between two individual groups. P-values less than 0.05 were considered statistically significant.Multiple linear regression was used to control for confounders.Data entry and analysis were entered and analyzed using the Statistical Package for Social Science (SPSS), version 28 (IBMNew York,United States).
RESULTS
The study included 196 patients with type 1 diabetes, with most (76.5%) being females. The ages ranged between 14 and 55 years, with an average of 23.7 years and a standard deviation of ± 9.2 years. Most of the patients (86.2%) lived in cities, were unmarried (82.7%), and not currently employed (78.1%). A significant proportion of the patients (42.4%) had completed university or postgraduate studies. Few patients (5.2%) reported a smoking history (current/previous). More than a third of patients were either overweight (21.4%) or obese (15.3%) (Table 1).
Duration of diabetes exceeded 10 years among 46% of patients . Additionally,12.7% reported a history of diabetic complications, such as neuropathy (6.1%) and retinopathy (5.1%). 59.7% had a history of hospital admission due to diabetic ketoacidosis (excluding diabetes-related ketoacidosis at diagnosis), with 16.8% admitted more than three times. However, about 34.7% of patients never adhered to their diabetic dietary regimen, while 49.5% sometimes adhered. More than 52.5% of patients were treated with multiple daily insulin injections. However, 25% were treated with insulin pumps with sensor G640/newer, 64 | Cardiometry | Issue 30. February 2024
Table 1
Personal characteristics of the participants (n = 196)
|
Total N=196 N (%) |
Insulin pump with sensor N=77 N (%) |
Insulin pump without sensor N=16 N (%) |
Multiple dose insulin inject N=103 N (%) |
|
|
Gender |
||||
|
Male |
46 (23.5) |
15 (19.5) |
5 (31.3) |
26 (25.2) |
|
Female |
150 (76.5) |
62 (80.5) |
11 (68.8) |
77 (74.8) |
|
Age in years |
||||
|
Range |
14-55 |
14-51 |
14-35 |
14-55 |
|
Mean±SD |
23.7±9.2 |
25.6±9.2 |
23.5±8.1 |
22.3±9.1 |
|
Residence |
||||
|
Village |
27 (13.8) |
10 (13.0) |
1 (6.3) |
16 (15.5) |
|
City |
169 (86.2) |
67 (87.0) |
15 (93.7) |
87 (84.5) |
|
Marital status |
||||
|
Married |
34 (17.3) |
16 (20.8) |
1 (6.3) |
17 (16.5) |
|
Unmarried |
162 (82.7) |
61 (79.2) |
15 (93.7) |
86 (83.5) |
|
Job status |
||||
|
Working |
43 (21.9) |
22 (28.6) |
2 (12.5) |
19 (18.4) |
|
Not working |
153 (78.1) |
55 (71.4) |
14 (87.5) |
84 (81.6) |
|
Highest qualification |
||||
|
Illiterate/prima-ry school |
30 (15.3) |
7 (9.1) |
2 (12.5) |
21 (20.4) |
|
Intermediate school |
24 (12.2) |
8 (10.4) |
2 (12.5) |
14 (13.6) |
|
Secondary school |
59 (30.1) |
25 (32.5) |
5 (31.3) |
29 (28.2) |
|
University |
76 (38.8) |
32 (41.5) |
7 (43.7) |
37 (35.9) |
|
Postgraduate |
7 (3.6) |
5 (6.5) |
0 (0.0) |
2 (1.9) |
|
Smoking status |
||||
|
Never smoke |
186 (94.8) |
74 (96.1) |
15 (93.7) |
97 (94.2) |
|
Current smoker |
5 (2.6) |
1 (1.3) |
1 (6.3) |
2 (1.9) |
|
Ex-smoker |
5 (2.6) |
2.6 |
0 (0.0) |
4 (3.9) |
|
Body mass index |
||||
|
Underweight (< 18.49) |
38 (19.4) |
11 (14.3) |
0 (0.0) |
27 (26.2) |
|
Normal (18.5-24.99) |
86 (43.9) |
37 (48.1) |
9 (56.2) |
40 (38.8) |
|
Overweight (25-29.99) |
42 (21.4) |
17 (22.1) |
4 (25.0) |
21 (20.4) |
|
Obese ( >30 ) |
30 (15.3) |
12 (15.6) |
3 (18.8) |
15 (14.6) |
SD: Standard deviation while 8.2% were treated with insulin pumps without a sensor. One-quarter of patients reported having other chronic diseases, with hypothyroidism being the most prevalent at 12.2%. Almost two-thirds (86.9%) of patients claimed to know how to calculate carbohydrates in grams, and 29.1% had more than three educators` visits in the past year (Table 2). Table 3 shows a significant difference in the level of last HbA1c among patients with T1DM treated with different insulin modalities. The patients treated with insulin pumps without sensors had the lowest level at 7.09 ± 0.97, while those treated with multiple daily insulin injections had the highest level of 8.35 ± 2.24. The p-value is 0.002, which indicates a significant difference, with p = 0.003 between the two groups.
Table 2
Diabetes-related characteristics of the participants (n = 196)
|
Total N=196 N (%) |
Insulin pump with sensor N=77 N (%) |
Insulin pump without sensor N=16 N (%) |
Multiple dose insulin inject N=103 N (%) |
|
|
Duration of diabetes in years |
||||
|
≤1 |
23 (11.7) |
1 (1.3) |
0 (0.0) |
22 (21.4) |
|
>1-5 |
43 (21.9) |
19 (24.7) |
2 (12.5) |
22 (21.4) |
|
>5-10 |
40 (20.4) |
11 (14.3) |
6 (37.5) |
23 (22.2) |
|
>10 |
90 (46.0) |
46 (59.7) |
8 (50.0) |
36 (35.0) |
|
History of diabetic complications |
||||
|
No |
173 (88.3) |
74 (96.1) |
14 (87.5) |
85 (82.5) |
|
Yes |
23 (12.7) |
3 (3.9) |
2 (12.5) |
18 (17.5) |
|
Neuropathy |
12 (6.1) |
2 (2.6) |
1 (6.3) |
9 (8.7) |
|
Diabetic foot |
1 (0.5) |
0 (0.0) |
0 (0.0) |
1 (1.0) |
|
CV diseases |
3 (1.5) |
0 (0.0) |
1 (6.3) |
2 (1.9) |
|
Nephropathy |
3 (1.5) |
1 (1.3) |
1 (6.3) |
1 (1.0) |
|
Retinopathy |
10 (5.1) |
1 (1.3) |
1 (6.3) |
8 (7.8) |
|
Non-alcoholic fatty liver |
1 (0.5) |
0 (0.0) |
0 (0.0) |
1 (1.0) |
|
History of admission due to diabetic ketoacidosis |
||||
|
No |
79 (40.3) |
37 (48.1) |
6 (37.5) |
36 (35.0) |
|
Yes |
117 (59.7) |
40 (51.9) |
10 (62.5) |
67 (65.0) |
|
Once |
46 (23.6) |
17 (22.1) |
0 (0.0) |
29 (28.2) |
|
Twice |
24 (12.2) |
10 (13.0) |
0 (0.0) |
14 (13.6) |
|
3 times |
14 (7.1) |
4 (5.2) |
1 (6.3) |
9 (8.7) |
|
>3 times |
33 (16.8) |
9 (11.7) |
9 (56.3) |
15 (14.6) |
SD: Standard deviation
*Not mutually exclusive
|
Compliance with diabetic regimen |
||||
|
Never |
68 (34.7) |
33 (42.8) |
6 (37.5) |
29 (28.2) |
|
Sometimes |
97 (49.5) |
34 (44.2) |
7 (43.7) |
56 (54.3) |
|
Always |
31 (15.8) |
10 (13.0) |
3 (18.8) |
18 (17.5) |
|
Medications taken* |
||||
|
Insulin pump with sensor G640/ newer |
49 (25.0) |
|||
|
Insulin pump without sensor |
16 (8.2) |
|||
|
Pump with freestyle librae |
28 (14.3) |
|||
|
Multiple dose insulin inject |
103 (52.5) |
|||
|
Metformin |
6 (3.1) |
|||
|
Statins |
1 (0.5) |
|||
|
Anti-hypertensive medications |
2 (1.0) |
|||
|
History of other chronic diseases |
||||
|
No |
147 (75.0) |
57 (74.0) |
13 (81.2) |
77 (74.8) |
|
Yes* |
49 (25.0) |
20 (26.0) |
3 (18.8) |
26 (25.2) |
|
Hypertension |
5 (2.6) |
3 (3.9) |
0 (0.0) |
2 (1.9) |
|
Cardiac diseases |
1 (0.5) |
0 (0.0) |
0 (0.0) |
1 (1.0) |
|
Renal diseases |
1 (0.5) |
0 (0.0) |
0 (0.0) |
1 (1.0) |
|
Hypothyroidism |
24 (12.2) |
12 (15.6) |
1 (6.3) |
11 (10.7) |
|
Celiac disease |
11 (5.6) |
2 (2.6) |
1 (6.3) |
8 (7.8) |
|
Addison’s disease |
1 (0.5) |
0 (0.0) |
1 (6.3) |
0 (0.0) |
|
Obesity |
10 (5.1) |
5 (6.5) |
1 (6.3) |
4 (3.9) |
|
Knowing how to calculate needed carbohydrates in grams |
||||
|
No |
21 (10.7) |
2 (2.6) |
1 (6.3) |
18 (17.5) |
|
Yes |
135 (68.9) |
64 (83.1) |
13 (81.2) |
58 (56.3) |
|
Maybe |
40 (20.4) |
11 (14.3) |
2 (12.5) |
27 (26.2) |
|
Number of educators` visits in last year |
||||
|
None |
50 (25.5) |
14 (18.2) |
4 (25.0) |
32 (31.1) |
|
One |
36 (18.4) |
14 (18.2) |
3 (18.8) |
19 (18.4) |
|
Two |
31 (15.8) |
13 (16.9) |
2 (12.5) |
16 (15.5) |
|
Three |
22 (11.2) |
12 (15.6) |
1 (6.3) |
9 (8.7) |
|
>three |
57 (29.1) |
24 (31.2) |
6 (37.5) |
27 (26.2) |
Table 3
Comparison of the level of last glycated hemoglobin between different lines of insulin treatment among patients with type 1 diabetes.
|
Insulin modality |
p-value* |
|||
|
Insulin pump with sensor N=77 Mean±SD |
Insulin pump without sensor N=16 Mean±SD |
Multiple dose insulin inject N=103 Mean±SD |
||
|
HbA1c% |
7.35±1.87° |
7.09±0.97† |
8.35±2.24° * |
0.002 |
SD: Standard deviation
*One-way analysis of variance
° p-value=0.003 (Tukey's post-hoc test)
†p-value=0.057 (Tukey’s post-hoc test)
Regarding patients` satisfaction with current treatment, recent convenience with treatment, flexibility of treatment, understanding of diabetes, recommendation of their form of treatment to someone else with T1DM, and continuity of their form of treatment, the highest score was observed among patients treated with insulin pump with sensor while the lowest one was observed among those treated with multiple daily insulin injections (p-value ranged between 0.004 and <0.001). Overall, the highest score of patients` satisfaction was observed among patients treated with
Insulin pump with sensor G640/newer 30.19 (6.56). In contrast, the lowest score was observed among patients treated with multiple daily insulin injections (23.29 ± 8.05), p<0.001 (Table 4).
The study revealed patients who received multiple daily insulin injections experienced the highest perceived frequency of hyperglycemia. On the other hand, patients treated with insulin pumps with sensors reported the lowest score. This difference was statistically significant(p=0.018).However, no significant difference was observed in the perceived frequency of hypoglycemia among patients in each insulin modality (Table 5).
Additionally, a negative correlation was found between the patient’s age and level of last HbA1c (r=-0.155, p=0.030). Furthermore, patients with diabetic complications had a significantly higher level of HbA1c compared to those without diabetic complications (8.84 ± 2.20 vs. 7.72 ± 2.03, p = 0.015). Patients knowledgeable in calculating dietary carbohydrates in grams had lower HbA1c levels than those not informed (7.53 ± 1.98 vs. 8.48 ± 2.22), p = 0.005 (Table 6).
Based on the findings in Table 7 , insulin pump with sensors had significantly lower HbA1c level than multiple daily insulin injections after controlling for confounding variables. The patient’s age has a mod-
Table 4
Comparison of patient satisfaction between different lines of insulin treatment among patients with type 1 diabetes.
|
Insulin modality |
p-value* |
|||
|
Insulin pump with sensor N=77 Mean (SD) |
Insulin pump without sensor N=16 Mean (SD) |
Multiple dose insulin inject N=103 Mean (SD) |
||
|
How satisfied are you with your current treatment? |
4.96 (1.36)° |
4.63 (1.71) |
3.66 (1.89)° |
<0.001 |
|
How convenient have you been finding your recent treatment? |
4.86 (1.61)ⱶ |
4.63 (1.67) |
4.06 (1.60)ⱶ |
0.004 |
|
How flexible have you been finding your recent treatment? |
5.04 (1.28)° |
4.31 (1.89) |
3.81 (1.49)° |
<0.001 |
|
How satisfied are you with your understanding of your diabetes? |
5.14 (1.23)ⱶ |
5.13 (1.71) |
4.38 (1.70)ⱶ |
0.003 |
|
Would you recommend this form of treatment to someone else having similar diabetes? |
5.47 (1.13)° |
5.25 (1.34) ⱡ |
4.09 (1.82)° * |
<0.001 |
|
How satisfied would you like to continue with your present form of treatment? |
4.73(1.63)° |
4.50 (1.97)• |
3.30 (1.99)° " |
<0.001 |
|
Overall satisfaction |
30.19 (6.56)° |
28.44 (8.18)* |
23.29 (8.05)°* |
<0.001 |
1. SD: Standard deviation
2. *One-way analysis of variance
3. °p-value<0.001 (Tukey>s post-hoc test)
4. *p-value=0.031 (Tukey’s post-hoc test)
5. ⱶp-value=0.003(Tukey`s post-hoc test)
6. ⱡ p-value=0.015 (Tukey’s post-hoc test)
7. •p-value=0.045 (Tukey’s post-hoc test)
Table 5
Comparison of hyper-/hypoglycemic experience between different lines of insulin treatment among patients with type 1 diabetes.
|
Insulin modality |
p-valueⱶ |
|||
|
Insulin pump with sensor N=77 Mean (SD) |
Insulin pump without sensor N=16 Mean (SD) |
Multiple dose insulin inject N=103 Mean (SD) |
||
|
How often have you felt that your blood sugars are unacceptably high recently? |
3.06 (1.71)* |
3.38 (1.54) |
3.75 (1.62)* |
0.018 |
|
How often have you felt your blood sugars have been unacceptably low recently? |
2.70 (1.88) |
3.13 (1.86) |
3.25 (1.75) |
0.129 |
SD: Standard deviation ⱶOne-way analysis of variance *p-value=0.018 (Tukey’s posthoc test)
Table 6
Factors associated with glycemic control among patients with type 1 diabetes mellitus
|
Variables |
Last HbA1c Mean (SD) |
P -value |
|
Gender |
||
|
Male |
7.77 (1.82) |
0.769* |
|
Female |
7.88 (2.16) |
|
|
Age in years |
r=-0.155 |
0.030† |
|
Residence |
||
|
Village |
7.70 (1.74) |
0.689* |
|
City |
7.88 (2.13) |
|
|
Marital status |
||
|
Married |
7.84 (2.37) |
0.956* |
|
Unmarried |
7.86 (2.02) |
|
|
Job status |
||
|
Working |
7.57 (1.86) |
0.321* |
|
Not working |
7.93 (2.14) |
|
|
Highest qualification |
||
|
Illiterate/primary school |
8.41 (1.66) |
|
|
Intermediate school |
8.38 (2.18) |
|
|
Secondary school |
8.0 (2.28) |
|
|
University |
7.42(2.04) |
|
|
Postgraduate |
7.11(0.91) |
0.087** |
|
Smoking status |
||
|
Never smoke |
7.85(2.07) |
|
|
Current smoker |
7.16(1.21) |
|
|
Ex-smoker |
9.78(2.59) |
0.086** |
|
Duration of diabetes in years |
||
|
≤1 |
8.90(2.97) |
|
|
>1-5 |
7.6(1.86) |
|
|
>5-10 |
7.85(1.65) |
|
|
>10 |
7.70(2.03) |
0.073** |
|
History of diabetic complications |
||
|
No |
7.72(2.03) |
|
|
Yes |
8.84(2.20) |
0.015* |
|
History of admission due to diabetic ketoacidosis |
||
|
No |
7.52(1.85) |
|
|
Yes |
8.08(2.20) |
0.069* |
|
Compliance with the diabetic regimen |
||
|
Never |
8.22(2.29) |
|
|
Sometimes |
7.51(1.78) |
|
|
Always |
7.49(1.81) |
0.052** |
|
History of other chronic diseases |
||
|
No |
7.86(2.22) |
|
|
Yes |
7.82(1.60) |
0.893* |
|
Knowing how to calculate needed carbohydrates in grams |
||
|
No |
8.48(2.22) |
|
|
Yes |
7.53(1.98) |
|
|
May be |
8.61(2.10) |
0.005* |
|
Number of educators` visits in last year |
||
|
None |
7.60(1.78) |
|
|
One |
7.88(2.66) |
|
|
Two |
7.53(1.53) |
|
|
Three |
7.50(1.72) |
|
|
>three |
8.38(2.25) |
0.220** |
HbA1c: Glycosylated hemoglobin
SD: Standard deviation
*Student’s t-test
**One-way analysis of variance (ANOVA) test
†Pearson correlation test
Table 7
Best fitting multiple linear regression model for glycosylated hemoglobin level among patients with type 1 diabetes mellitus.
|
Unstandardized Coefficients |
Standardized Coefficients |
t-test |
p-value |
95% Confidence Interval for B |
|||
|
B |
Std. Error |
Lower |
Upper |
||||
|
Constant |
7.487 |
0.548 |
13.659 |
<0.001 |
|||
|
Age in years |
-0.030 |
0.016 |
-0.132 |
-1.887 |
0.061 |
-0.061 |
0.001 |
|
Insulin pump with sensors (reference: multiple insulin inject) |
0.365 |
0.114 |
0.223 |
3.195 |
0.002 |
0.14 |
0.59 |
R-square = 0.073, Adjusted R2 = 0.063
Model ANOVA: F = 7.593, p = 0.001
Variables entered and excluded: Adherence to diet regimen and knowing how to calculate needed carbohydrates in gram.
|
est impact on HbA1c levels, with approximately 7% variability attributed to this factor (r-square=0.073). However, adherence to diet regimen and knowledge of carbohydrate calculations in grams were not significantly associated with HbA1c levels. The study revealed that patients who could calculate carbohydrates in grams reported higher satisfaction levels than those who lacked this skill. The satisfaction score for individuals who could calculate carbohydrates was 27.24±7.81, while those who could not calculate carbohydrates had a significantly lower score of only 21.71 ± 9.93, p = 0.015. Moreover, the study found that the number of educators’ visits significantly impacted patients` satisfaction.Patients who received more than three visits had the highest satisfaction score of 29.12 ± 7.14, while those who did not receive any visit had the lowest score of 23.72±9.16, p = 0.014 (Table 8). Table 8 Factors associated with satisfaction among patients with type 1 |
Variables |
Patient`s satisfaction Score Mean (SD) |
P-value |
|||
|
Unmarried |
26.20(8.35) |
0.413* |
||||
|
Job status |
||||||
|
Working |
27.02(7.92) |
|||||
|
Not working |
26.25(8.27) |
0.588* |
||||
|
Highest qualification |
||||||
|
Illiterate/primary school |
24.23(9.73) |
|||||
|
Intermediate school |
26.17(6.59) |
|||||
|
Secondary school |
26.12(8.51) |
|||||
|
University |
27.22(7.96) |
|||||
|
Postgraduate |
30.57(2.70) |
312** |
||||
|
Smoking status |
||||||
|
Never smoke |
26.56(8.21) |
|||||
|
Current smoker |
25.20(9.47) |
|||||
|
Ex-smoker |
22.60(5.68) |
0.536** |
||||
|
Duration of diabetes in years |
||||||
|
diabetes mellitus. |
≤1 |
22.48(8.73) |
||||
|
Variables |
Patient`s satisfaction Score Mean (SD) |
P-value |
||||
|
>1-5 |
27.00(7.89) |
|||||
|
>5-10 |
26.45(7.93) |
|||||
|
>10 |
27.14(8.14) |
0.099** |
||||
|
Gender |
||||||
|
History of diabetic complications |
||||||
|
Male |
26.52(8.43) |
|||||
|
No |
26.79(8.05) |
|||||
|
Female |
26.39(8.13) |
0.926* |
||||
|
Yes |
23.65(8.86) |
0.084* |
||||
|
Age in years |
r = 0.078 |
0.276† |
||||
|
History of admission due to diabetic ketoacidosis |
||||||
|
Residence |
||||||
|
Village |
26.26(7.72) |
No |
27.30(7.94) |
|||
|
City |
26.45(8.28) |
0.911* |
Yes |
25.83(8.32) |
0.217* |
|
|
Marital status |
Compliance with diabetic regimen |
|||||
|
Married |
27.47(7.34) |
Never |
26.87(9.04) |
|||
|
Variables |
Patient`s satisfaction Score Mean (SD) |
P-value |
|
Sometimes |
25.67(7.76) |
|
|
Always |
27.81(7.46) |
0.387** |
|
History of other chronic diseases |
||
|
No |
26.46(8.13) |
|
|
Yes |
26.33(8.42) |
.0924* |
|
Knowing how to calculate needed carbohydrates in grams |
||
|
No |
21.71(9.93) |
|
|
Yes |
27.24(7.81) |
|
|
May be |
26.13(7.78) |
0.015** |
|
Number of educators` visits in last year |
||
|
None |
23.72(9.16) |
|
|
One |
25.44(8.37) |
|
|
Two |
26.55(7.78) |
|
|
Three |
27.00(6.93) |
|
|
>three |
29.12(7.14) |
0.014** |
SD: Standard deviation
*Student’s t-test
**One-way analysis of variance (ANOVA) test †Pearson correlation test
As shown in Table 9, patients who used insulin pumps with sensors experienced higher satisfaction than those who relied on multiple daily insulin injections after control for confounding variables. Moreover, patients with a higher number of educator visits reported greater satisfaction. When these factors were considered, they accounted for approximately 20% variability of the patient’s satisfaction score (r-square=0.202).
DISCUSSION
Managing TIDM can be challenging for healthcare providers and patients. The unpredictable changes in blood sugar levels and high rate of poor glycemic control make it difficult to manage this condition effectively. As a result, the study was conducted primarily to compare glycemic control and satisfaction with medications. Specifically,the study looked at insulin pumps with or without sensors(suspended in low and pre-low) and multiple daily insulin injections among patients with type 1 diabetes.
After conducting univariate and multivariate analyses on patients’ data, this study discovered that HbA-1clevel, which measured glycemic control, was better in patients who received treatment through insulin pumps with sensors than those treated with multiple daily insulin injections. This is could be explained by the fact that insulin infusion allows better control over insulin injection due to better adjustment of insulin dosing in different activity levels.12-13 Previous Saudi studies (Hayek et al. 2015) also discovered that positive differences were observed in HbA1c levels in female patients and those with a shorter duration of T1DM after 6 months from baseline.14However, this study found no correlation between patients` gender or duration of diabetes and glycemic control.
Hermanides et al. (2011) observed that patients with type 1 diabetes who had HbA1c ≥ 8.2% were randomized to continue daily multiple insulin injections
Table 9
Best fitting multiple linear regression model for patient satisfaction among patients with type 1 diabetes mellitus.
|
Unstandardized Coefficients |
Standardized Coefficients |
t-test |
p-value |
95% Confidence Interval for B |
|||
|
B |
Std. Error |
Lower |
Upper |
||||
|
Constant |
31.286 |
1.533 |
20.412 |
< 0.001 |
|||
|
Insulin pump with sensors (reference: multiple insulin inject) |
-3.250 |
0.558 |
-0.378 |
-5.827 |
< 0.001 |
-4.35 |
-2.15 |
|
Number of educators` visits in last year (reference: No) |
1.034 |
0.336 |
0.199 |
3.076 |
0.002 |
0.37 |
1.70 |
R-square = 0.202, Adjusted R2 = 0.194
Model ANOVA: F = 24.446, p < 0.001
Variables entered and excluded: Knowing how to calculate needed carbohydrates in grams.
or shifted to sensor-augmented pump therapy.As a result, sensor-augmented pump therapy significantly lowered HbA1c compared to multiple daily insulin in-jections.15In a similar study conducted by Bergenstal, the efficacy of sensor-augmented pump therapy with multiple daily insulin injections was compared. It was observed that the level of HbA1c% decreased to 7.5% from baseline in the sensor-augmented pump therapy group compared to 8.1% in the multiple daily insulin injections group. Furthermore, the rate of glycemic control (HbA1<7%) was greater in the sensor-augmented pump therapy than in the multiple daily insulin injections.16
Buse et al. (2012) compared the effectiveness of SAIP for one year in T1DM patients with multiple daily injections. The study found that sensor glucose values were similar in the SAIP and multiple daily injections groups when HbA1c levels were ≥ 6.5%.How-ever, sensor glucose standard deviation was lower at HbA1c levels< 8% among SAIP than among multiple daily injection group.7
This study found that patient` satisfaction was improved even after control for confounders in multivariate analysis in patients treated with insulin pump with sensors compared to those treated with multiple daily insulin injections. Similar findings have been reported at local14and international levels.12,13,17Various factors could explain this clear advantage of insulin pump with sensors over multiple insulin injection as regards to improvement of patients` satisfaction, including decreased sense of physical and dietary restrictions accompanied by therapy with multiple insulin injec-tion.18Additionally, having confidence in one’s ability to control the disease and self-efficacy associated with using insulin pumps with sensors are crucial in patient satisfaction,19 particularly in children.20
In agreement with our finding, Hussain et al. (2017)17also observed that patients who used a sensor-augmented insulin pump reported a higher satisfaction score than those treated with multiple insulin injections in general feelings about type of treatment, ease of utilization of treatment method and confidence in managing the disease. Also, flexibility associated with insulin pump with sensors has important benefit,21as it helps patients to make different types of adjustments in various situations such as exercise, types and timings of food, dose, and required variable basal rates.18
We found that patients were more satisfied when they had more visits from health educators`, as con- 70 | Cardiometry | Issue 30. February 2024
firmed by multivariate analysis, highlighting the importance of these visits.Some studies from Western countries observed female patients are less satisfied with the insulin pump due to the visibility of a pump to others.22,23However, no gender difference is observed in this regard. This finding may be attributed to using the full-length, sleeveless outer garment called “abaya” by females, which covers almost the whole body.14
Our findings also show that patients treated with multiple insulin injections have the highest perceived frequency of hyperglycemia but the lowest among those treated with insulin pumps with sensors. However, no difference between medications was observed concerning the frequency of hypoglycemic symptoms in the two treatment modalities.Another Saudi study found that treatment with an insulin pump with a sensor significantly decreased the frequency of hyperglycemia and hypoglycemia in female patients at 6 months and in patients who had a shorter duration of T1DM.14Ber-genstal et al.found no significant difference in the rate of severe hypoglycemia between groups treated by either sensor-augmented pump therapy and those treated with multiple daily insulin injections.16
This study has some limitations. First,it was implemented at a single center. However, this center is a major one where patients with T1DM from different places in Riyadh are treated. Moreover, we could not achieve the required sample size in each group of treatments, particularly those with insulin pumps without sensors. Despite the two significant limitations, the study could have clinical implications for managing patients with type 1 diabetes and expanding the research for the newer generations of hybrid closed pumps in the Kingdom of Saudi Arabia.
CONCLUSION
Treating patients with T1DM on insulin pumps with sensors is superior to using multiple daily insulin injections in glycemic control and treatment satisfaction. Additionally, the perceived frequency of hyperglycemia was lowest among those treated with insulin pumps. Finally, frequent visits to diabetic educators improved the medication satisfaction of patients with type 1 diabetes.
Declaration of Conflict of Interest
The authors declare no affiliation with any organization or entity with any financial interest in the subject matter or materials discussed in this manuscript.
Funding
The corresponding author will fully fund this study.
Ethical approval
This study was approved by the Institutional Review Board of the king Abdullah International Medical Research Center , reference No.RC20/120/R, Date: 22 October 2020.
Acknowledgment
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