One-Year Efficacy and Safety of the Telehealth System in Poorly Controlled Type 2 Diabetic Patients Receiving Insulin Therapy

Abstract

Objective: To evaluate the functionality of the telehealth system in poorly controlled type 2 diabetic (T2D) patients receiving insulin injections. Materials and Methods: Sixty-four patients with glycosylated hemoglobin (HbA_1c) values >7% for more than 1 year were included. All patients underwent an intensive diabetes management program, including titration of insulin, blood glucose-self monitoring, and nutritional review, and 32 participated in the telehealth system. The major outcome was to evaluate the change of the HbA_1c and body weight, the incidence of hospitalization, and hypoglycemic events. Results: After 1-year management, patients receiving telehealth care had significantly improved HbA_1c levels (9.5%±1.8% to 8.1%±1.2%; p<0.01) without significant body weight gain. In contrast, the control group patients had no significant improvement in HbA_1c levels but showed significant increase in body weight (66.8±9.8 to 67.3±10.0 kg; p<0.01). No patient in the telehealth group was hospitalized during the follow-up period, but six patients in the control group were. Intergroup differences in hypoglycemic events were absent. Conclusion: The intensive diabetes management program with the telehealth system is a useful education method to improve blood sugar control and prevent hospitalization in poorly controlled T2D patients receiving insulin injections.

Introduction

Patients with type 2 diabetes mellitus are at increased risk for complications related to both microvascular and macrovascular events.¹ These complications not only markedly reduce the quality and length of life but are also responsible for enormous healthcare costs. A large body of evidence has clearly shown that a number of effective treatments and practices may substantially reduce this burden.² The risks of developing diabetic complications can be significantly reduced by optimizing the glycemic control.^3,4

Diabetes self-management education (DSME) is the key to obtaining satisfactory glycemic control.² Self-management consists of medication use (insulin or oral hypoglycemic agent), a healthy diet, sufficient physical activity, self-monitoring of blood sugar levels, healthy coping with psychosocial problems, problem solving of acute complications, and reducing risk factors,⁵ but many patients have difficulties with self-management.⁵

Conventional diabetes education programs primarily focus on improving the knowledge to improve glycemic control.^6,7 By the recent technical innovations, telehealth systems have been designed to promote patient self-management, patient education, clinical monitoring, and follow-up activities and are expected to result in a significant improvement in glycemic control.^8
–10

Initiating insulin therapy earlier in the course of diabetes mellitus has the potential to improve blood glucose control over time¹¹ and even to induce remissions^12,13; tight glycemic control in patients with diabetic mellitus can be achieved by intensive insulin therapy.^14,15 The primary care diabetes educator (DE) plays an important role in helping patients manage their disease by encouraging initiation or continuation of treatment with insulin analogs. Telehealth systems are applied in many diabetes monitoring and/or treatment research projects and expected to result in a significant improvement in glycemic control.^9,16 However, only a few studies on the analysis of home telehealth systems were conducted in patients who receive intensive insulin treatment, and some have failed to show the expected improvement in the patients' glycemic control.^9,17 The aim of this study was to evaluate a telehealth system on a designed intensive diabetes management program for poorly controlled glycemic type 2 diabetic (T2D) patients receiving insulin therapy.

Materials and Methods

Subjects And Biochemistry Measurements

A total of 64 subjects were recruited from the Tri-Service General Hospital Diabetes Center. All study subjects were of Han Chinese origin, and all lived in the same region at the time of the study. These diabetic participants received insulin injection treatment combined with/without oral anti-hyperglycemic drugs. Their glycosylated hemoglobin (HbA_1c) value was >7% for 1 year at least. All of these patients had enrolled into an integrated diabetic care system. Thirty-two patients who agreed to use a telehealth platform possessed the ability and knowledge to manipulate the system, and communicated without difficulty were selected as the experimental group. Thirty-two sex-, age-, and disease duration-matched patients were randomly selected from our clinic and used as the control group. Their blood pressure was checked by a trained nurse, who measured the blood pressure with a digital automatic blood pressure monitor (Omron, model HEM-907) after the subjects had rested for five minutes. Plasma biochemical parameters were measured after an 8-h (at least) overnight fast. HbA_1c was measured in whole blood using ion exchange high-performance liquid chromatography (BIO-RAD^®; VARIANTTM II Turbo). Plasma triglycerides, total cholesterol, low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), and glucose were measured by standard commercial methods on a parallel, multi-channel analyzer (Hitachi 7170A). This study was approved by the institutional review board of the Tri-Service General Hospital in Taiwan.

Diabetes Education

A designed intensive diabetes management program was performed for all diabetic patients (Table 1). In this study, this program was also practiced in addition to the telehealth platform and the telephone system. Patients received phone calls from DEs on days 3, 7, 14, and 60 after registration for specific barrier education, data explanation, confidence establishment, and insulin dose adjustment. Patients had to visit outpatient clinics on day 30 and every 3 months. The most frequent education pathway was prompt education when abnormal data were observed. The DEs called the patients to solve problems and to respond to concerns about their health conditions.

Table 1.

Intensive Care Program

SCHEDULE^a	EDUCATION PATHWAY	EDUCATION STRATEGY	EDUCATION CONTENT
Registration	Outpatient clinic	1–7	1. Barrier identification
Day 3	Phone call	1, 3, 4, 6	2. Whole education
Day 7	Phone call	1, 3, 4, 6, 8	3. Specific barrier education
Day 14	Phone call	1, 3, 4, 6, 8	4. Blood glucose data explanation
Month 1	Outpatient clinic	1–8	5. Glycemic goal establishment
Month 2	Phone call	1, 3, 4, 6, 8	6. Confidence establishment
Every 3 months	Outpatient clinic	1–8	7. Operation skill training
			8. Insulin dose adjustment

Although the education schedule was set, diabetes educators telephoned patients frequently for prompt education and concerns.

Telehealth System

Patients assigned to the telehealth system received a 1-hour education program to initiate the use of the telehealth system. These participants had a phone, and each patient or their family had Internet access at home and knew how to use the Internet. A telehealth device package was offered to each subject upon completion. The package included a blood glucose meter, a telehealth data analysis platform, and a telephone system, a USB cable, and a login ID for the telehealth platform. The different strategy in the telehealth group is that patients were asked to measure their blood glucose level according to their physicians or DEs recommended frequencies: 8-h fasting blood glucose once daily for patients who received basal insulin; 8-h fasting blood glucose and pre-lunch or pre-dinner blood glucose for patients who received pre-mix insulin; 8-h fasting blood glucose and 2-h postprandial blood glucose for patients who received multiple daily injections. Patients were asked to upload their data before the scheduled date on which the DEs would make the phone calls. Beyond the scheduled contact date, patients could contact their DEs at any time when necessary without difficulty. The DEs who monitored and analyzed the data on the platform gave prompt education and warm care to patients on the phone. The doctors adjusted the patients' insulin dosages according to the information on the platform.

Questionnaire

All participants were asked to record their hypoglycemic events, visits to the emergency department (ER), and times of hospitalization during the study. A hypoglycemic event was defined as any symptomatic characteristic of hypoglycemia associated with documented low blood sugar recorded by each diabetic patient. An ER visit was defined as ER visit for any cause. Times of hospitalization were defined as admission to the hospital due to serious hyperglycemia, serious hypoglycemia, or any other events.

Statistical Analysis

All continuous data are shown as the mean±SD. Baseline characteristics of case and control subjects were compared by Student's t-tests. Paired t-tests were used to compare the differences between the characteristics of baseline and 1-year follow-up. Chi-square tests were performed for comparison of categorical variables. Since the distributions of serum triglycerides and HDL-C were skewed, logarithmically transformed values were used for statistical analysis. All statistical analyses were two-sided, and a p-value <0.05 was considered significant. Data were analyzed with the Statistical Package for the Social Sciences (SPSS version 14.0).

Results

The basic characteristics of the diabetic participants are listed in Table 2. There were no significant differences regarding age, gender, body weight, and systolic blood pressure between the two groups. There were also no significant differences in the duration of having a diabetic disease, education levels, and insulin injection duration between these two groups. There were no differences in the values of HbA_1c, total cholesterol, HDL-C, LDL-C, and triglycerides, but the diastolic blood pressure was higher in the telehealth group.

Table 2.

Clinical Characteristics and Baseline Laboratory Data of the Groups

CHARACTERISTICS	CONTROL ( N= 32)	TELEHEALTH ( N= 32)	P
Age (years)	55.8±17.5	51.8±15.8	0.340
Male/female	14/18	15/17	0.802
Married/single	27/5	21/11	0.175
Education level ≤6 years/>6 years	10/22	6/26	0.238
Diabetes duration (years)	15.1±9.5	12.3±7.2	0.194
Insulin duration (years)	6.5±7.4	4.6±7.4	0.322
HbA_1c (%)	9.6±1.5	9.5±1.8	0.780
Cholesterol (mg/dL)	186.8±40.8	170.7±33.3	0.088
Triglyceride (mg/dL)	208.0±214.1	145.8±131.1	0.166
LDL-C (mg/dL)	104.9±27.5	102.1±24.4	0.667
HDL-C (mg/dL)	40.2±38.3	39.4±32.2	0.923
SBP (mmHg)	131.5±14.6	129.6±17.2	0.639
DBP (mmHg)	83.3±7.2	77.6±1.0	0.011
Body weight (kg)	66.8±9.8	64.8±13.9	0.509

Data are presented as mean±SD.

HbA_1c, glycosylated hemoglobin; LDL-C, low-density lipoprotein-cholesterol; HDL-C, high-density lipoprotein cholesterol; SBP, systolic blood pressure; DBP, diastolic blood pressure.

Comparisons between baseline and 1-year follow-up HbA1c and body weight changes are demonstrated in Figure 1. After 1-year follow-up, we found there was no significant improvement in the HbA1c value (differences: −0.6±2.6; p=0.202) but a significant increase in body weight (differences: 0.5±1.3 kg; p=0.044) in the control group. However, there was a significant improvement in the HbA_1c value (differences: −1.4±1.5; p<0.001) in the telehealth group, but without body weight change (differences: −0.5±2.6; p=0.231). There were no significant differences in the total cholesterol, LDL-C, HDL-C, and triglyceride levels as compared to the baseline lipid profile in each study group (data were not shown).

Fig. 1.

The changes of HbA1c level and body weight after 1-year follow-up in both groups. HbA_1c, glycosylated hemoglobin.

A summary of hypoglycemic episodes and records of hospitalization during the follow-up period are listed in Table 3. There was significantly less hospitalization for any cause in the telehealth group than in the conventional group (telehealth group: 0; conventional group: 6). However, the number of hypoglycemic events and ER visits was similar in both study groups.

Table 3.

Questionnaires of the Groups

CHARACTERISTICS	CONTROL ( N= 32)	INTERVENTION ( N= 32)	P
Hypoglycemia among last month	5	4	0.719
Had ever been hospitalized during the past 1 year	6	0	0.010
Had ever gone to the emergency room during the past 1 year	4	2	0.391

Data are presented as number of episodes.

Discussion

In the present study, we demonstrated that poorly controlled T2D patients, who received insulin therapy in addition to an intensive management program, including the telehealth care system, could improve their glycemic control, had a lower incidence of hospitalization, and less body weight gain. It has been clearly demonstrated that better glycemic control is helpful in reducing microvascular and macrovascular complications in T2D patients.^3,18 Unfortunately, long-duration T2D patients with decreased β-cell function need to start insulin therapy to achieve ideal glycemic control. However, there are often difficulties in the initiation, titration, and maintenance of insulin therapy for these diabetic patients.

The telehealth system has been recently proved to be an effective management to sustain the effect of DSME in diabetic patients. Shea reported that, in the general diabetic population, telehealth care improved the HbA_1c, LDL-C, and blood pressure values as compared with the usual conventional care.¹⁹ Further, Shea reported that these improvements could last for 5 years.^19,20 At the same time, Turner et al. reported that the telehealth system improved the glycemic control after 3 months of intervention in T2D patients who initiated insulin therapy.²¹ Our results after 1 year of intervention confirmed these observations in T2D patients who received insulin therapy. This finding shows that telehealth is an effective management to assist diabetic individuals to start and continue the insulin treatment needed to manage their glycemic control. Our results also indicated that telehealth empowers conventional DSME and leads to glycemic improvement in T2D patients receiving insulin therapy.

We found a significant reduction in the proportion of hospitalization in the telehealth group and suggested that the telehealth system might be helpful in lowering the necessity for hospitalization in diabetic patients. In an observational study, Chumbler et al. reported a significant reduction in the proportion of diabetic patients who were hospitalized, emergency room use, and the average number of bed days of care by a Veterans Health Administration care coordination/home-telehealth program.²² According to a 2-year follow-up report, Barnett and colleagues reported that the home telehealth program reduced the likelihood of all-cause and DM-related hospitalizations for veterans diagnosed with type 2 diabetes mellitus.²³ Our result further supported the concept that the telehealth system lowered the need for hospitalization for any cause in T2D patients receiving insulin therapy. This is particularly important since it shows that a reduction in the health insurance burden can possibly be provided by the telehealth system in diabetic patients receiving insulin therapy.

In the present study, we found that the telehealth group had improved HbA_1c values without an increase in body weight. This finding is interesting since it suggests that the telehealth system can counteract the disadvantage of body weight gain brought by insulin therapy. In particular, the fear of body weight gain in diabetic patients may be one of the barriers in titration and continuance of insulin therapy.²⁴ From the literature, we knew that the telehealth system had been used in a weight maintenance program and was reported to be effective in preventing body weight gain after 6 months in patients of obesity with the telehealth program.²⁵ Recently, Stone et al. reported that diabetic veterans who participated in active care management with home telemonitoring program (ACM+HT) had improved HbA_1c values rather than an increase in body weight at the 3-month and 6-month follow-up.²⁶ Of note, over 50% of the participants who were enrolled into the ACM+HT program received insulin injections, and the average daily dose was ∼18 U higher than the control group during the follow-up period.²⁶ Together with our results, this observation suggests that the frequent interactions between patients and DEs connected by the telehealth system are helpful in sustaining the body weight in T2D patients receiving insulin treatment.

The strength of the telehealth system is to offer a convenient tool and a real-time method to provide the DEs with each patient's health status, including blood sugar levels, over a distance. Therefore, the telehealth system provides a more patient-friendly healthcare and adapts to the needs of each diabetic patient, instead of asking the patient to visit the clinic. This makes diabetic patients more willing to communicate with the DEs, which may help improving the glycemic control. Norris et al. reported that every 23.6-h additional contact between the DEs and T2D patients lowered the HbA_1c value by 1%.²⁷ Very recently, Swinnen et al. demonstrated that the contact frequency is a significant determinant of the improvement in HbA_1c values by titration of the basal insulin dosage in T2D patients who had initiated insulin therapy.²⁸ In addition to the regimen adjustment, this technology is also helpful in communicating with diabetic patients about their psychological stress. These benefits in the health management will contribute to the patient's health maintenance.¹⁶

The limitation of the present study was that we could not specifically indicate which behavior change was associated with these improvements, since there was incomplete documentation of the changes of behavior after introduction of the telehealth system. However, our results were empowered by a prospective cohort design, which could avoid the influence of regression to the mean in a single-group study design, as demonstrated by other groups.^21,22 Of note, in contrast to the improvement in diabetic patients brought by conventional DSME, which may be diminished after 6 months,²⁷ our result demonstrated a sustained effect of the telehealth system in the reduction of the HbA_1c value, need for hospitalization, and maintenance of the body weight after 1-year follow-up.

In brief, many diabetic patients have an aversion to insulin injections. Therefore, it is necessary to provide a practical solution to encourage these diabetic patients to continue the insulin therapy. In this study, we found that T2D patients under insulin therapy could improve their HbA_1c values, have a lower rate of hospitalization, and maintain their body weight. We suggest a combination of this useful education method of conventional diabetic care and the telehealth system for diabetic patients undergoing insulin treatment.

Footnotes

Disclosure Statement

No competing financial interests exist.

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