Telemedicine Strategy With Home Treatment Save Resources

Type 2 Diabetes Mellitus Clinical Trial

Official title: Can a Telemedicine Strategy With Home Treatment Save Resources in Acute Medical Conditions While Maintaining Quality of Care?

Status Completed

Clinical Trial Summary

Progress in technology has made telemedicine-based solutions with video consultations available in the management and treatment of chronic diseases like diabetes, heart failure and lung insufficiency at home. However, no direct comparisons on health outcomes of telemedicine using video consultations versus usual outpatient treatment are available.

We wanted to implement a model of telemedicine and to evaluate health indicators in type 2 diabetes patients treated by video consultations or the standard outpatient treatment

Clinical Trial Description

Chronic illnesses, such as asthma, diabetes, heart failure, and hypertension, represent a significant burden of disease Chronic diseases also impose huge costs on the health care systems responsible for managing them as well as their significance for those affected.

Non-pharmacological treatment is mandatory for type 2 diabetes patients characterized by central obesity, sedentary lifestyle, and overeating (1). Secondary failure to reach treatment goals despite an extensive National diabetes rehabilitation program in Denmark is often seen (2). Outpatient control shows positive effects on outpatient rehabilitation (3) reducing HbA1c, weight, and blood pressure. However, some patients never accomplish good diabetes regulation and in others regulation deteriorates over time. New approaches are required and need testing to motivate and give feedback to the patients at home. Telemedicine has the capacity to achieve this, where a diabetic nurse may optimize motivation, treatment, and diet through direct feedback adapted to milieu of the patient in accordance with a potential spouse.

Good metabolic control is important as diabetes is inevitable a factor for increased risk of cardiovascular disease, neuropathy, and nephropathy (4). The quality of life and reduction in work ability is affected, thus, life expectancy is shortened by 6-8 years. Multi-factorial intervention may delay this (5).

The high incidence of the serious implications strengthens the importance of achieving good metabolic control through lifestyle changes. Health education shows reduction in cardiovascular risk factors (6-8), which often disappears after the end of the intervention (6-8). Good self-care and compliance improve the outcome and reduces diabetes complications (9) and we need new tools to achieve higher attendance to the National diabetes program. Telemedicine represents a novel tool of educating and controlling chronic diseases. It reduced HbA1c for five years with in trials designed to test video-conferencing, clinical data entry and review, web-based education materials, and monitored chat groups (10). Home telemonitoring was compared with telephone calls reducing the HbA1c levels in type 2 diabetes (11) and the technology confer a statistically significant reduction in HbA1c of 0.5 % when applied as add-on to standard treatment. It was used adjunctively to a broader telemedicine initiative for adults with diabetes. The largest telemedicine study initiated by the Ministry of Health in England (Whole Systems Demonstrator) randomized 3320 patients [12] with heart failure and diabetes to telemedicine care. It showed that the telemedicine intervention as add-on therapy resulted a statistically significant reduction in mortality from 8.3% versus 4.6%. Similarly, it showed a reduction of number of inpatients and the number of bed days by 11% and 14%, respectively. The patients' health-related quality of life was unchanged. The savings was less than the additional cost of using telemedicine and overall it cost 15% more per patient. This point at two important factors when applying telemedicine solutions: First, it should preferably replace the standard care and not add-on and, second, be based on the patient's own computer, tablet or smartphone, all of which will reduce the cost substantially. Telemedicine is available for 98-99% of all inhabitants in Denmark by broadband, which allows video conference at home. A few randomized trials with this technology are available at present. We aimed at implementing a telemedicine model in our setting and the design and method should evaluate the quality of treatment as well as technical problems and replace the standard treatment.

Aim:

We compared clinical data from a telemedicine group with a standard care group treated by the same medical algorithm. We wanted to reduce the barriers for the use of a home monitoring and -treatment among elderly, type 2 diabetes patients

Hypothesis:

Treatment by telemedicine or standard care in type 2 diabetes patients results in similar clinical HbA1c, blood pressure, and lipids.

Materials and methods:

Individually visits at the outpatient clinic to plan improvement of glycemic control were made before information of the study was given. Individual goals of the treatment and the drugs needed to fulfil the objectives were agreed on. The patients received the information for the study, and if they wanted to participate, they signed an approval of participation and randomization was performed. All medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group In the control group patients attended usual procedure in the outpatient clinic with regular visits. Summary of recommendations for glycemic, blood pressure, and lipid control for the participants were: HbA1c 6.5-7.5% (48-58 mmol/L) , fasting blood glucose 6.5-7.5 mmol/l, diurnal blood pressure < 130/80 mmHg, LDL-cholesterol <100 mg/dL (<2.5 mmol/L) and start of medication with elevated urinary albumin/creatinine excretion ≥30 (μg/mg). The treatment algorithm was lifestyle adjustment plus antidiabetic drugs described elsewhere. When the goals were reached within 3 weeks, the videotelephone was disconnected and patients were encouraged to continue glycemic control at their general practitioner. However, the trial went on with a follow-up and evaluation after six month according to the 'intention-to-treat' principle to see if a difference in the initial care mattered significantly.

A videotelephone in the telemedicine group was delivered and serviced by the Danish Tele Company. The trial included type 2 diabetes patients allocated from October 2011 until July 2012 referred to the outpatient clinic from general practitioners. At entry, all patients were screened by albumin/creatinine excretion rate, blood pressure, and electrocardiogram, lipid profile, diabetic food control, and arteriosclerotic symptoms (angina pectoris, claudication, and fatigue). Diurnal blood pressure was measured by monitors. All measurements were repeated six months after inclusion in all participants ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT02214017
• Study type: Interventional
• Source: Kolding Sygehus
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Completion date: October 2012