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Previous studies on telemedicine interventions have shown that older diabetic patients experience difficulty in using computers, which is a barrier to remote communication between medical teams and older diabetic patients. However, older people in China tend to find it easy to use mobile phones and personal messaging apps that have a user-friendly interface. Therefore, we designed a mobile health (mHealth) system for older people with diabetes that is based on mobile phones, has a streamlined operation interface, and incorporates maximum automation.
The goal of the research was to investigate the use of mobile phone–based telemedicine apps for management of older Chinese patients with type 2 diabetes mellitus (T2DM). Variables of interest included efficacy and safety.
A total of 91 older (aged over 65 years) patients with T2DM who presented to our department were randomly assigned to one of two groups. Patients in the intervention group (n=44) were provided glucometers capable of data transmission and received advice pertaining to medication, diet, and exercise via the mHealth telemedicine system. Patients assigned to the control group (n=47) received routine outpatient care with no additional intervention. Patients in both groups were followed up at regular 3-month intervals.
After 3 months, patients in the intervention group showed significant (
Mobile phone–based telemedicine apps help improve glycemic control in older Chinese patients with T2DM.
China Clinical Trial Registration Center ChiCTR 1800015214; http://www.chictr.org.cn/showprojen.aspx?proj=25949 (Archived by WebCite at http://www.webcitation.org/73wKj1GMq).
Diabetes mellitus is one among the top three chronic, noninfectious diseases in the world [
A previously conducted computer-based telemedicine study [
In this study, we conducted a mobile medical intervention experiment lasting for half a year to determine whether a diabetes mHealth management system based on mobile phones is suitable for older patients. We also evaluated the impact of using this system on glycemic control, treatment adherence, and the rate of occurrence of adverse events (for example, hypoglycemia), as well as overall satisfaction.
The study protocol was designed in accordance with the Declaration of Helsinki and was approved by the ethics committee of the First Affiliated Hospital of Jilin University. This trial was registered at the China Clinical Trial Registration Center (ChiCTR 1800015214). Written informed consent was obtained from all patients prior to their enrollment.
Patients who attended the outpatient endocrinology department of the First Affiliated Hospital of Jilin University between March and September 2016 were eligible for inclusion in this randomized controlled trial.
Inclusion criteria in this study were age older than 65 years, glycated hemoglobin (HbA1c) level 7.0% to 10.0%, and the ability to use a mobile phone. Exclusion criteria were illiteracy, abnormal liver and kidney function, severe diabetic complications, use of insulin pumps, and participation in other clinical trials.
A total of 91 patients were enrolled: 44 (19 males) in the intervention group and 47 (18 males) in the control group.
Patients were randomly assigned to the intervention and control groups using the random number sequence generated by SPSS Statistics version 17.0 (IBM Corp) in batches of 6 patients at a time. Patients in the intervention group were provided training to independently use the mHealth management app and upload the glucometer data, which was then automatically transmitted to the medical server (glucometer was connected to the mobile phone via Bluetooth). The medical teams logged on to the system and sent medical advice and reminders to patients to monitor their glucose levels via the personal messaging app or telephonically every 2 weeks. Patients in the control group received a free glucometer and were followed up through conventional outpatient clinic appointments. For the control group patients, no limitations were imposed to the number of visits; however, they were instructed to monitor and record their blood glucose data regularly.
The study dietitian offered guidance for blood glucose monitoring and provided dietary advice based on the individual blood glucose levels. Patients in the intervention group used the app-based diet management software to input daily dietary intake. The dietitian received the daily dietary record of each patient via the mHealth app. On the basis of the analysis of this information, once-monthly dietary recommendations were sent from the dietitian to patients in the intervention group. The control group received dietary guidance from dietitians during face-to-face meetings at baseline and at the conclusion of all study-related procedures.
Information pertaining to physical activity (daily calorie expenditure) was obtained from patients in the intervention group via text message. The patients were instructed on how to text pedometer data to the study personnel. This information was analyzed, and each patient in the intervention group was provided with guidance related to aerobic and resistance-based exercises. In the control group, guidance related to exercise was provided during face-to-face dietary counseling session during clinic visits.
All patients were followed up in the outpatient clinic at 3-month intervals. Patients in both groups underwent physical examination, blood biochemical tests, follow-up clinic visits, and ambulatory therapy by the same medical team.
In order to assess the condition of patients, the following data were reviewed at baseline and every 3 months until the end of the experiment (a total of 3 times): medical history, treatment details, physical examination, and laboratory investigations. Patient compliance was assessed by the frequency of uploading blood glucose data in the intervention group. At the end of the experiment, all patients completed a satisfaction questionnaire, which contained 7 questions, with each question awarded a score of 1 and the highest possible total score being 7 points. Higher total score indicated better satisfaction.
Data were processed using SPSS Statistics version 17.0 (IBM Corp). Normally distributed variables are presented as mean and standard deviation; nonnormally distributed variables are presented as median and interquartile range. Between-group differences to normally distributed variables were assessed using an independent sample
Baseline characteristics of the study population are summarized in
HbA1c level reflects the level of glycemic control over the past 3 months. After the first 3 months, we noted a significant improvement in HbA1c levels over the baseline level in both the control group (7.18% [SD 0.85%] vs 7.88% [SD 0.64%],
At 6 months, the HbA1c level in the intervention group was significantly lower than that at baseline (6.84% [SD 0.765%] vs 7.84% [SD 0.73%],
After 6 months, we obtained satisfactory results from the survey of patients in the intervention group. Higher total scores indicated better satisfaction. The average satisfaction score was 6.3 (SD 0.78). Individual questions measured details regarding whether the intervention improved the self-monitoring of patients’ blood glucose levels (0.93 [SD 0.14]), diet, exercise and other self-management skills (0.85 [SD 0.20]), and knowledge of diabetes (0.98 [SD 0.08]), as well as the effect on their psychological status (0.96 [SD 0.12];
Baseline characteristics of the two groups.
Characteristic | Control (n=47) | Intervention (n=44) | |
Age in years, median (IQR)a | 68.04 (66-72) | 67.9 (66-71) | .85 |
Gender, male, n (%) | 18 (38) | 19 (43) | —b |
Diabetes mellitus, duration in years, mean (SD) | 11.52 (7.73) | 11.19 (6.39) | .80 |
FBGc (mmol/L), mean (SD) | 7.78 (1.85) | 8.0 (2.54) | .41 |
PBGd (mmol/L), mean (SD) | 12.44 (3.37) | 13.10 (4.13) | .46 |
HbA1ce (%), mean (SD) | 7.88 (0.64) | 7.84 (0.73) | .53 |
TCf (mmol/L), mean (SD) | 4.92 (1.24) | 5.00 (0.97) | .76 |
TGg (mmol/L), mean (SD) | 2.31 (1.85) | 2.41 (1.82) | .80 |
HDL-Ch (mmol/L), median (IQR) | 1.21 (1.05-1.40) | 1.09 (0.85-1.25) | .28 |
LDL-Ci (mmol/L), median (IQR) | 2.86 (2.28-3.67) | 2.92 (2.37-3.29) | .84 |
BUNj (mmol/L), median (IQR) | 5.79 (4.76-6.69) | 5.62 (5.13-7.05) | .39 |
Crk (mmol/L), median (IQR) | 59.1 (52.58-69.98) | 65.05 (54.28-76.58) | .26 |
ASTl (U/L), median (IQR) | 21.00 (17.50-24.00) | 21.30 (17.75-24.25) | .53 |
ALTm (U/L), median (IQR) | 20.00 (13.00-32.25) | 20.50 (14.70-30.00) | .83 |
r-GTn (U/L), median (IQR) | 20.00 (16.00-26.75) | 24.5 (19.00-36.00) | .80 |
Body mass index, median (IQR) | 23.30 (21.93-25.88) | 23.60 (22.48-26.38) | .63 |
Blood pressure (mm Hg), systolic, mean (SD) | 136.04 (19.37) | 132.55 (11.82) | .55 |
Blood pressure (mm Hg), diastolic, median (IQR) | 80.00 (73.50-90.00) | 83.00 (74.00-87.75) | .99 |
aIQR: interquartile range.
bIndicates a range of values.
cFBG: fasting blood glucose.
dPBG: postprandial blood glucose.
eHbA1c: glycated hemoglobin.
fTC: total cholesterol.
gTG: triglyceride.
hHDL-C: high-density lipoprotein–cholesterol.
iLDL-C: low-density lipoprotein–cholesterol.
jBUN: blood urea nitrogen.
kCr: creatinine.
lAST: aspertate aminotransferase.
mALT: alanine aminotransferase.
nr-GT: r-glutamyltransferase.
The follow-up data of the two groups.
Characteristics | 3 months | 6 months | ||||
Control | Intervention | Control | Intervention | |||
FBGa (mmol/L), mean (SD) | 7.57 (2.15) | 7.20 (1.70) | .41 | 7.24 (2.49) | 7.26 (2.17) | .96 |
PBGb (mmol/L), mean (SD) | 13.15 (3.64) | 12.09 (3.35) | .04 | 12.19 (2.54) | 10.62 (2.07)c | .004 |
HbA1cd (%), mean (SD) | 7.18 (0.85)e | 6.97 (0.65)e | .25 | 7.22 (0.87) | 6.84 (0.76)e | .02 |
TCf (mmol/L), mean (SD) | 4.84 (1.08) | 4.94 (0.80) | .57 | 4.66 (1.19) | 4.63 (0.70) | .88 |
TGg (mmol/L), mean (SD) | 1.69 (0.97) | 1.66 (0.84)e | .86 | 1.75 (0.86) | 1.79 (0.87) | .80 |
HDL-Ch (mmol/L), median (IQRi) | 1.34 (1.12-1.51) | 1.30 (1.07-1.45) | .39 | 1.30 (1.15-1.49) | 1.2 (1.02-1.35) | .46 |
LDL-Cj (mmol/L), median (IQR) | 2.99 (2.08-3.52) | 2.87 (2.64-3.27) | .56 | 2.85 (2.03-3.61) | 2.88 (2.43-3.14) | .68 |
BMIk, median (IQR) | 23.25 (22.13-26.23) | 23 (22.68-27.43) | .07 | 22.62 (21.55-24.45) | 23.8 (22.5-27.3) | .30 |
Blood pressure (mm Hg), systolic, mean (SD) | 140.61 (14.433) | 137.05 (15.07) | .40 | 130.69 (11.22) | 134.48 (9.08) | .22 |
Blood pressure (mm Hg), diastolic, median (IQR) | 80 (69-86.75) | 79 (73.75-84.25) | .86 | 79 (75-84) | 80 (78-84) | .78 |
aFBG: fasting blood glucose.
bPBG: postprandial blood glucose.
c
dHbA1c: glycated hemoglobin.
e
fTC: total cholesterol.
gTG: triglyceride.
hHDL-C: high-density lipoprotein–cholesterol.
iIQR: interquartile range.
jLDL-C: low-density-lipoprotein–cholesterol.
kBMI: body mass index.
The changes in HbA1c levels after follow-up in both groups. After 3 months, HbA1c levels in both groups were significantly improved compared with baseline data (
The comparison of the amplitude of change of HbA1c levels in both groups. The mean change in HbA1c levels from baseline to 6 months in the intervention group was significantly higher than that in the control group (
The changes in postprandial blood glucose levels after follow-up in both groups. At the end of 3 and 6 months, the intervention group postprandial blood glucose was significantly lower than the control group postprandial blood glucose (
We completed a 6-month, prospective, randomized controlled trial of the mHealth telemedicine system in patients with T2DM aged over 65 years. The results showed that the PBG and HbA1c levels in the intervention group were significantly lower than those in the control group; our results are very similar to those reported by Lim et al [
Previous studies have shown that telemedicine interventions can improve blood glucose control in patients with diabetes [
The study by Quinn et al [
In general, telemedicine facilitates good glycemic control in older diabetic patients. In this study, the personal and family medical history, smoking history, history of alcohol intake, birth history, history of drug allergy, and personal living environment were not included in the analysis [
In this study, PBG level in the intervention group was significantly lower than that in the control group after the first 3 months. The improvement in glycemic control was sustained after 6 months and showed a significant difference from that in the control group. Our results suggest that the improved glycemic control in the intervention group was attributable to improved communication between doctors and patients with real-time tracking of older diabetic patients by the mHealth system and improved patient compliance after implementation of mHealth monitoring. On the basis of our findings, we can conclude that telemedicine is effective and safe for older diabetic patients.
Satisfaction survey.
CONSORT‐EHEALTH checklist (V 1.6.1).
glycated hemoglobin
postprandial blood glucose
type 2 diabetes mellitus
This study was supported by the Science Technology Department of Jilin Province (20180623006TC) and the Interdisciplinary Project of First Hospital of Jilin University (JDYYJC010).
None declared.