Background
Persistently poor glycemic control in adult type 1 diabetes patients is a common, complex, and serious problem initiating significant damage to the cardiovascular, renal, neural, and visual systems. Currently, there is a plethora of low-cost and free diabetes self-management smartphone applications available in online stores.
Objective
The aim of this study was to examine the effectiveness of a freely available smartphone application combined with text-message feedback from a certified diabetes educator to improve glycemic control and other diabetes-related outcomes in adult patients with type 1 diabetes in a two-group randomized controlled trial.
Methods
Patients were recruited through an online type 1 diabetes support group and letters mailed to adults with type 1 diabetes throughout Australia. In a 6-month intervention, followed by a three-month follow-up, patients (n=72) were randomized to usual care (control group) or usual care and the use of a smartphone application (Glucose Buddy) with weekly text-message feedback from a Certified Diabetes Educator (intervention group). All outcome measures were collected at baseline and every three months over the study period. Patients’ glycosylated hemoglobin levels (HbA1c) were measured with a blood test and diabetes-related self-efficacy, self-care activities, and quality of life were measured with online questionnaires.
Results
The mean age of patients was 35.20 years (SD 10.43) (28 male, 44 female), 39% (28/72) were male, and patients had been diagnosed with type 1 diabetes for a mean of 18.94 years (SD 9.66). Of the initial 72 patients, 53 completed the study (25 intervention, 28 control group). The intervention group significantly improved glycemic control (HbA1c) from baseline (mean 9.08%, SD 1.18) to 9-month follow-up (mean 7.80%, SD 0.75), compared to the control group (baseline: mean 8.47%, SD 0.86, follow-up: mean 8.58%, SD 1.16). No significant change over time was found in either group in relation to self-efficacy, self-care activities, and quality of life.
Conclusions
In adjunct to usual care, the use of a diabetes-related smartphone application combined with weekly text-message support from a health care professional can significantly improve glycemic control in adults with type 1 diabetes.
Trial Registration
Australian New Zealand Clinical Trials Registry: ACTRN12612000132842; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000132842 (Archived by WebCite at http://www.webcitation.org/6Kl4jqn5u).
Keywords: type 1 diabetes, mobile health, mobile phone, text message, education
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Introduction
Persistently poor glycemic control in adult type 1 diabetes patients is a common, complex, and serious problem initiating significant damage to the cardiovascular, renal, neural, and visual systems [1]. In many patients, glycosylated hemoglobin levels (HbA1c) are unsatisfactory, with levels consistently above 8.0% [2]. In the pursuit of improving metabolic control, the importance of self-monitoring blood glucose is widely appreciated and recommended as a routine part of management in patients with type 1 diabetes [3]. There are a number of barriers to glycemic control in type 1 diabetes, including the fear of hypoglycemia and the demands of day-to-day management, in particular the need for frequent self-monitoring of blood glucose and regular adjustments in insulin dosing [4]. Additionally another difficulty is a patient’s logbook, either paper-based or electronic, that a clinician is presented with at a consultation. Clinicians often face a lack of information on which to base their advice regarding their patient’s self-care [5,6]. Utilizing mobile phone technology may help to overcome these difficulties.
The worldwide prevalence of mobile phones makes them a powerful platform for providing individualized health care delivered at the patient’s convenience. Several reviews have documented the effectiveness, potential, and challenges in using mobile phones to improve health outcomes in diabetes [7-14]. Growing evidence suggests that utilizing mobile phones may improve diabetes self-management and clinical outcomes; however, this evidence is much stronger for type 2 populations than type 1 populations [9].
In recent years, mobile phones have improved dramatically in both design and function, from simple call and text devices to the more sophisticated mini-personal computers known as smartphones. Smartphone owners are now more prevalent within the overall population than owners of traditional mobile phones [15]. Smartphones allow individual users to install, configure, and run specialized applications on their phone. Increasing numbers of people are using these applications to self-manage chronic diseases [13]. For example, Chomutare and colleagues [16] identified that in 2011 there were more than 260 diabetes-related iPhone applications available for download from the Apple online store.
A small number of prototypes of type 1 diabetes smartphone applications have been developed and tested in clinical settings [2,17-21]. However, with the plethora of low-cost and free self-management diabetes applications currently available in online markets (Apple iPhone, Google Android, BlackBerry, and Nokia Symbian), it is pertinent to examine their effectiveness when integrated in secondary care [16]. Therefore, the aim of this study was to examine the effectiveness of a freely available smartphone application combined with text-message feedback to improve glycemic control and other diabetes-related outcomes in adult patients with type 1 diabetes in a two-group randomized controlled trial.
Go to:
Methods
Design
The study, utilizing a two-arm (usual care and intervention) randomized controlled trial with measures at baseline, 3, 6, and 9 months (Figure 1), was conducted with the assistance of a Certified Diabetes Educator (CDE). Participants were recruited nationally by means of an invitation letter sent to type 1 diabetes patients registered with Diabetes Australia in New South Wales (n=3809) and Queensland (n=3207), as well as an advertisement in a type 1 diabetes national newsletter (Yada Yada newsletter) emailed to more than 5000 recipients and promotion in an online community forum (Reality Check Forum). Study inclusion criteria were: (1) aged 18-65 years, (2) diagnosed with type 1 diabetes >6 months, (3) HbA1c >7.5%, (4) treated with multiple daily injections or insulin pump, and (5) own a smartphone (iPhone). Patients were excluded if they were pregnant or already using a smartphone application to self-manage their diabetes. This study was approved by Central Queensland University Human Research Ethics Board.
Figure 1
Participant flow. Note: Reason for subject “lost to follow-up” could not be determined as patients could not be re-contacted. CDE: Certified Diabetes Educator.
After confirming eligibility (via phone call) and obtaining written informed consent (via email) from the patient and their primary diabetes health care practitioner (general practitioner or endocrinologist), the study coordinator randomized patients using a freely available online randomization program. A permuted block randomization design method was used during the 3-month rolling recruitment to ensure roughly equal numbers of patients were allocated to each comparison group [22]. There was no face-to-face contact between the patients and research team at any point in the study, which allowed participants to live anywhere in Australia.
Intervention
Patients in both groups were asked to continue with their usual care, which included a visit to their primary diabetes health care practitioner every 3 months. Additionally, patients allocated to the intervention arm were given instructions to download the smartphone application named “Glucose Buddy”. Glucose Buddy is a freely available diabetes self-management iPhone application that allows users to manually enter blood glucose levels, insulin dosages, other medications, diet (food item in grams), and physical activities (minutes) [16,23]. Users can also view their data on a customizable graph and export this information via email (Figures 2 and and3).3). Glucose Buddy was developed by SkyHealth LLC and was first made available on iTunes (Apple online store) in October 2008. Glucose Buddy has been reported to be the most downloaded diabetes management software on iOS, with downloads in excess of 100,000. There was no minimum amount of logging required and intervention patients were able to utilize the accompanying Glucose Buddy website to log diabetes parameters at their discretion.
Figure 2
Glucose Buddy screenshots of the menu and adding a log.
Figure 3
Glucose Buddy screenshots of the graphic display of logs and option to set up reminders.
The information logged in the Glucose Buddy application was reviewed by a CDE via a Web interface on a weekly basis. All patients in the intervention arm were sent a minimum of 1 personalized text-message communication per week for the first 6 months of the study. At the 6-month timeframe, all text-message communication ceased.
Measures
All measures were collected at baseline and every 3 months over the 9-month study period for both groups (making 4 time points in total). The primary outcome measure was change in glycemic control assessed by HbA1c, which was collected by a pathology lab at the request of the patients’ general practitioner or endocrinologist as per usual care (every 3 months) and then forwarded to the research team. The secondary outcome measures, being diabetes-related self-efficacy, self-care activities, and quality of life, were collected via a Web-based survey. Details to access this survey were emailed to patients.
Diabetes-related self-efficacy was measured using the short form of the Diabetes Empowerment questionnaire (DES-SF). The DES-SF questionnaire measures eight conceptual dimensions relevant to the management
พื้นหลังปัญหาทั่วไป ซับซ้อน และอย่างจริงจังเริ่มต้นความเสียหายระบบหัวใจและหลอดเลือด ไต ประสาท และภาพสำคัญ glycemic ต่ำสามารถควบคุมในผู้ป่วยโรคเบาหวาน 1 ชนิดผู้ใหญ่ได้ ในปัจจุบัน มีโปรแกรมสมาร์ทโฟนจัดการตนเองเบาต้น ทุนต่ำ และฟรีให้เลือกมากมายในร้านค้าออนไลน์วัตถุประสงค์จุดมุ่งหมายของการศึกษานี้เป็นการตรวจสอบประสิทธิภาพของการใช้สมาร์ทโฟนที่พร้อมใช้งานได้อย่างอิสระรวมกับข้อติชมจากประวัติผู้สอนและโรคเบาหวานได้รับการรับรองปรับปรุง glycemic ควบคุมและผลลัพธ์อื่น ๆ ที่เกี่ยวข้องกับโรคเบาหวานในผู้ป่วยผู้ใหญ่ที่มีชนิดโรคเบาหวาน 1 ในการทดลองควบคุม randomized 2 กลุ่มวิธีการผู้ป่วยถูกพิจารณาเป็นกลุ่มสนับสนุน 1 เบาหวานชนิดออนไลน์และจดหมายที่ส่งให้ผู้ใหญ่ที่มีโรคเบาหวานชนิด 1 ออสเตรเลีย ในการแทรกแซง 6 เดือน ตาม ด้วยสามเดือน ติดตามผู้ป่วย (n = 72) randomized การดูแลปกติ (กลุ่มควบคุม) หรือดูแลตามปกติ และใช้เป็นสมาร์ทโฟนแอพลิเคชัน (กลูโคสเพื่อน) กับรายสัปดาห์ข้อติชมจากการรับรองโรคเบาหวานประวัติผู้สอนและ (แทรกแซงกลุ่ม) ประเมินผลทั้งหมดได้รวบรวมพื้นฐานและทุกสามเดือนในช่วงที่ศึกษา ระดับฮีโมโกลบิน glycosylated ผู้ป่วย (HbA1c) ถูกวัด ด้วยเลือด และโรคเบาหวานที่เกี่ยวข้องกับตนเองประสิทธิภาพ กิจกรรมสุขภาพ และคุณภาพชีวิตถูกวัด ด้วยแบบสอบถามออนไลน์ผลลัพธ์อายุเฉลี่ยของผู้ป่วยถูก 35.20 ปี (SD 10.43) (28 เพศชาย เพศหญิง 44), 39% (28/72) ถูกชาย และผู้ป่วยได้รับการวินิจฉัยกับโรคเบาหวานชนิดที่ 1 สำหรับค่าเฉลี่ยของปี 18.94 (SD 9.66) ผู้ป่วยเริ่มต้น 72, 53 เสร็จสิ้นการศึกษา (แทรกแซง 25 กลุ่มควบคุม 28) กลุ่มแทรกแซงปรับปรุง glycemic ควบคุม (HbA1c) จากพื้นฐาน (เฉลี่ย 9.08%, SD 1.18) ติดตาม 9 เดือน (เฉลี่ย 7.80%, SD 0.75), เมื่อเทียบกับกลุ่มควบคุมอย่างมีนัยสำคัญ (พื้นฐาน: 8.47%, SD 0.86 ติดตามผลหมายถึง: หมายถึง 8.58%, SD 1.16) ไม่เปลี่ยนแปลงที่สำคัญเวลาผ่านพบในกลุ่มใดเกี่ยวกับตนเองประสิทธิภาพ กิจกรรมสุขภาพ และคุณภาพชีวิตบทสรุปในเกียรติคุณการดูแลปกติ การใช้แอพลิเคชันสมาร์ทโฟนที่เกี่ยวข้องกับโรคเบาหวานรวมกับรายสัปดาห์ข้อสนับสนุนจากมืออาชีพดูแลสุขภาพสามารถมากปรับปรุงควบคุม glycemic ในผู้ใหญ่ที่มีโรคเบาหวานชนิด 1ลงทะเบียนทดลองใช้รีจิสทรีในการทดลองทางคลินิกออสเตรเลียนิวซีแลนด์: ACTRN12612000132842 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000132842 (เก็บถาวร โดย WebCite ที่ http://www.webcitation.org/6Kl4jqn5u)คำสำคัญ: พิมพ์โรคเบาหวาน 1 สุขภาพมือถือ โทรศัพท์มือถือ ข้อความ การศึกษาลุยเลย:แนะนำPersistently poor glycemic control in adult type 1 diabetes patients is a common, complex, and serious problem initiating significant damage to the cardiovascular, renal, neural, and visual systems [1]. In many patients, glycosylated hemoglobin levels (HbA1c) are unsatisfactory, with levels consistently above 8.0% [2]. In the pursuit of improving metabolic control, the importance of self-monitoring blood glucose is widely appreciated and recommended as a routine part of management in patients with type 1 diabetes [3]. There are a number of barriers to glycemic control in type 1 diabetes, including the fear of hypoglycemia and the demands of day-to-day management, in particular the need for frequent self-monitoring of blood glucose and regular adjustments in insulin dosing [4]. Additionally another difficulty is a patient’s logbook, either paper-based or electronic, that a clinician is presented with at a consultation. Clinicians often face a lack of information on which to base their advice regarding their patient’s self-care [5,6]. Utilizing mobile phone technology may help to overcome these difficulties.The worldwide prevalence of mobile phones makes them a powerful platform for providing individualized health care delivered at the patient’s convenience. Several reviews have documented the effectiveness, potential, and challenges in using mobile phones to improve health outcomes in diabetes [7-14]. Growing evidence suggests that utilizing mobile phones may improve diabetes self-management and clinical outcomes; however, this evidence is much stronger for type 2 populations than type 1 populations [9].In recent years, mobile phones have improved dramatically in both design and function, from simple call and text devices to the more sophisticated mini-personal computers known as smartphones. Smartphone owners are now more prevalent within the overall population than owners of traditional mobile phones [15]. Smartphones allow individual users to install, configure, and run specialized applications on their phone. Increasing numbers of people are using these applications to self-manage chronic diseases [13]. For example, Chomutare and colleagues [16] identified that in 2011 there were more than 260 diabetes-related iPhone applications available for download from the Apple online store.A small number of prototypes of type 1 diabetes smartphone applications have been developed and tested in clinical settings [2,17-21]. However, with the plethora of low-cost and free self-management diabetes applications currently available in online markets (Apple iPhone, Google Android, BlackBerry, and Nokia Symbian), it is pertinent to examine their effectiveness when integrated in secondary care [16]. Therefore, the aim of this study was to examine the effectiveness of a freely available smartphone application combined with text-message feedback to improve glycemic control and other diabetes-related outcomes in adult patients with type 1 diabetes in a two-group randomized controlled trial.
Go to:
Methods
Design
The study, utilizing a two-arm (usual care and intervention) randomized controlled trial with measures at baseline, 3, 6, and 9 months (Figure 1), was conducted with the assistance of a Certified Diabetes Educator (CDE). Participants were recruited nationally by means of an invitation letter sent to type 1 diabetes patients registered with Diabetes Australia in New South Wales (n=3809) and Queensland (n=3207), as well as an advertisement in a type 1 diabetes national newsletter (Yada Yada newsletter) emailed to more than 5000 recipients and promotion in an online community forum (Reality Check Forum). Study inclusion criteria were: (1) aged 18-65 years, (2) diagnosed with type 1 diabetes >6 months, (3) HbA1c >7.5%, (4) treated with multiple daily injections or insulin pump, and (5) own a smartphone (iPhone). Patients were excluded if they were pregnant or already using a smartphone application to self-manage their diabetes. This study was approved by Central Queensland University Human Research Ethics Board.
Figure 1
Participant flow. Note: Reason for subject “lost to follow-up” could not be determined as patients could not be re-contacted. CDE: Certified Diabetes Educator.
After confirming eligibility (via phone call) and obtaining written informed consent (via email) from the patient and their primary diabetes health care practitioner (general practitioner or endocrinologist), the study coordinator randomized patients using a freely available online randomization program. A permuted block randomization design method was used during the 3-month rolling recruitment to ensure roughly equal numbers of patients were allocated to each comparison group [22]. There was no face-to-face contact between the patients and research team at any point in the study, which allowed participants to live anywhere in Australia.
Intervention
Patients in both groups were asked to continue with their usual care, which included a visit to their primary diabetes health care practitioner every 3 months. Additionally, patients allocated to the intervention arm were given instructions to download the smartphone application named “Glucose Buddy”. Glucose Buddy is a freely available diabetes self-management iPhone application that allows users to manually enter blood glucose levels, insulin dosages, other medications, diet (food item in grams), and physical activities (minutes) [16,23]. Users can also view their data on a customizable graph and export this information via email (Figures 2 and and3).3). Glucose Buddy was developed by SkyHealth LLC and was first made available on iTunes (Apple online store) in October 2008. Glucose Buddy has been reported to be the most downloaded diabetes management software on iOS, with downloads in excess of 100,000. There was no minimum amount of logging required and intervention patients were able to utilize the accompanying Glucose Buddy website to log diabetes parameters at their discretion.
Figure 2
Glucose Buddy screenshots of the menu and adding a log.
Figure 3
Glucose Buddy screenshots of the graphic display of logs and option to set up reminders.
The information logged in the Glucose Buddy application was reviewed by a CDE via a Web interface on a weekly basis. All patients in the intervention arm were sent a minimum of 1 personalized text-message communication per week for the first 6 months of the study. At the 6-month timeframe, all text-message communication ceased.
Measures
All measures were collected at baseline and every 3 months over the 9-month study period for both groups (making 4 time points in total). The primary outcome measure was change in glycemic control assessed by HbA1c, which was collected by a pathology lab at the request of the patients’ general practitioner or endocrinologist as per usual care (every 3 months) and then forwarded to the research team. The secondary outcome measures, being diabetes-related self-efficacy, self-care activities, and quality of life, were collected via a Web-based survey. Details to access this survey were emailed to patients.
Diabetes-related self-efficacy was measured using the short form of the Diabetes Empowerment questionnaire (DES-SF). The DES-SF questionnaire measures eight conceptual dimensions relevant to the management
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