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Type 2 Diabetes MellitusNCT02214017

Telemedicine Strategy With Home Treatment Save Resources

A study testing A videotelephone, TandBerg E20, and Behavioral motivation in people with Type 2 Diabetes Mellitus, run by Kolding Sygehus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
A videotelephone, TandBerg E20, and Behavioral motivation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteDenmark
Study dates
Oct 2011to Oct 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participants had to live at home, be able to communicate by videotelephone, had no psychiatric disorders, an age between 40 and 85 years and be able to administer medication. -

Who cannot join

  • Exclusion criteria were type 1 diabetes, speech disabilities, non-Danish speakers or with severe chronic disease like renal failure (GFR<30 ml/min), liver insufficiency or in cancer treatment.
  • -

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Endrinology Dept, Kolding Hospital

    Kolding, 6000

Other trials in Denmark

About this study

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

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

Read the detailed 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

Being tested
A videotelephone, TandBerg E20,, Behavioral motivation
Keywords
diabetes, telemedicine, glycemia, lipids, blood pressure
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A videotelephone, TandBerg E20,Device

  • Behavioral motivationBehavioural

    Optimization of medical care in diabetes

Study groups in NCT02214017
Study groupRoleWhat they receive
Standard careActive comparatorDiabetic patients attended usual procedure in the outpatient clinic with regular visits
Receives: Behavioral: Behavioral motivation
Telemedicine groupExperimentalAfter initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.
Receives: Device: A videotelephone, TandBerg E20,; Behavioral: Behavioral motivation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemia

    Percent of glycosylated hemoglobin, HbA1c

    Measured: Six months of treatment

Secondary outcomes (1)
  1. Lipids

    Total-cholesterol

    Measured: Six months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2014 (estimated)
  2. Study startOct 2011
  3. Primary completionJul 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02214017
Sponsor's protocol ID
Telemedicine in type 2 DM
Status last verified
Nov 2018
First submitted
11 Aug 2014
Last updated
19 Nov 2018
Data monitoring committee
No

Publications

  • Bower P, Cartwright M, Hirani SP, Barlow J, Hendy J, Knapp M, Henderson C, Rogers A, Sanders C, Bardsley M, Steventon A, Fitzpatrick R, Doll H, Newman S. A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: protocol for the whole systems demonstrator cluster randomised trial. BMC Health Serv Res. 2011 Aug 5;11:184. doi: 10.1186/1472-6963-11-184.

    PubMed 21819569
  • Shea S, Weinstock RS, Teresi JA, Palmas W, Starren J, Cimino JJ, Lai AM, Field L, Morin PC, Goland R, Izquierdo RE, Ebner S, Silver S, Petkova E, Kong J, Eimicke JP; IDEATel Consortium. A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. J Am Med Inform Assoc. 2009 Jul-Aug;16(4):446-56. doi: 10.1197/jamia.M3157. Epub 2009 Apr 23.

    PubMed 19390093
  • Stone RA, Rao RH, Sevick MA, Cheng C, Hough LJ, Macpherson DS, Franko CM, Anglin RA, Obrosky DS, Derubertis FR. Active care management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial. Diabetes Care. 2010 Mar;33(3):478-84. doi: 10.2337/dc09-1012. Epub 2009 Dec 15.

    PubMed 20009091
  • Wootton R. Twenty years of telemedicine in chronic disease management--an evidence synthesis. J Telemed Telecare. 2012 Jun;18(4):211-20. doi: 10.1258/jtt.2012.120219.

    PubMed 22674020
  • Rasmussen OW, Lauszus FF, Loekke M. Telemedicine compared with standard care in type 2 diabetes mellitus: A randomized trial in an outpatient clinic. J Telemed Telecare. 2016 Sep;22(6):363-8. doi: 10.1177/1357633X15608984. Epub 2015 Oct 14.

    PubMed 26468213

Questions about this trial

What is this clinical trial studying?

A study testing A videotelephone, TandBerg E20, and Behavioral motivation in people with Type 2 Diabetes Mellitus, run by Kolding Sygehus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemia (time frame: Six months of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02214017, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.

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