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Diabetes Mellitus, Type 2NCT04038528

Telemedical Devices in the Management of Type 2 Diabetes Mellitus to Improve Diabetic Control and Quality of Life

An observational study of Diabetes Mellitus, Type 2, run by Centro Studi Internazionali, Italy at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to understand, in adult patients with Type 2 diabetes mellitus, if the use of telemedicine (monitoring and treatment without patients having to attend a healthcare facility) and home-based care is more effective than traditional general practitioner (GP) and outpatient care in terms of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
telemonitoring of T2DM
How many people
350 participants
Where
1 siteItaly
Study dates
1 Mar 2018to 31 Jul 2020
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with type 2 diabetes mellitus (T2DM) with diagnosis of DM made at least 1 year before the start of the study

Who may be able to join

  • Patients with type 2 diabetes mellitus (T2DM)
  • Diagnosis of DM made at least 1 year before the start of the study
  • Hypoglycemic treatment remained the same in the 3 months preceding the start of the study

Who cannot join

  • Diabetes other than T2DM
  • Pregnant women
  • Chronic conditions other than T2DM
  • Unable to give informed consent
  • Dementia or psychiatric conditions that can affect a person's will or ability to participate in the study

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • ASP Catanzaro

    Catanzaro, 88100

Other trials in Italy

About this study

Official title: Effect on Glucose Control and Quality of Life for People With Type 2 Diabetes of Using a Device to Measure Glucose Levels at Home and Send Them to the Clinic, Rather Than Attending an Out-patient Clinic for Blood Tests

The aim of this study is to understand, in adult patients with Type 2 diabetes mellitus, if the use of telemedicine (monitoring and treatment without patients having to attend a healthcare facility) and home-based care is more effective than traditional general practitioner (GP) and outpatient care in terms of patients taking medication regularly and their quality of life.

The hypothesis of this study is that patients with Type 2 diabetes mellitus uploading data on a telemedicine system achieve a glycemic control, evaluated in terms of glycated hemoglobin levels, similar to that of patients followed in a traditional diabetes outpatient department, with improvements to quality of life

Read the detailed description

Background and study aims Diabetes mellitus is a long-lasting disease in which the level of blood sugar is higher than normal. High level of sugar in the blood can lead to serious consequences, including blindness, kidney failure, amputation of limbs, coma and death. Patients with diabetes need to regularly take their medicine and to make sure they monitor the level of sugar in their blood on daily basis. This can affect their quality of life. The aim of this study is to understand if telemedicine (monitoring and treatment without patients having to attend a healthcare facility) and home-based care is more effective than traditional GP and outpatient care in terms of patients taking medication regularly and their quality of life.

Who can participate? Men and women who live in the study area, have been diagnosed with type 2 diabetes at least 1 year before the start of the study and have been on the same treatment for at least 3 months.

What does the study involve? The participants will be recruited by GPs and doctors working in diabetes centres. Participants will be randomly assigned to one of two groups. One group will be treated and followed according as usual. They will test their blood sugar level at home and record it on paper. They will attend a diabetes outpatient clinic for follow-up. The other group will record the level of blood sugar using a digital home-based system that will send data to the diabetes clinic for follow-up. All participants will receive treatment as appropriate from the clinic. At the end of the study (after 18 months), the two groups will be compared to assess which group achieved a better control of their blood sugar level and which experienced a better quality of life, assessed using a questionnaire. The participants will also have their height, weight, waist circumference, blood pressure, cholesterol and blood fats measured at the beginning and end of the study.

What are the possible benefits and risks of participating? All patients will receive medication as usual and the control group will continue to attend outpatient clinic, so there are no additional risks associated with participating in the trial. The telemedicine group might benefit from avoiding the inconvenience of having to attend outpatient clinics and from a more rapid response to changes in their blood sugar level from the clinic.

Being tested
telemonitoring of T2DM
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • telemonitoring of T2DMBehavioural

    Baseline record of:

    • Weight
    • Height
    • BMI
    • Abdominal circumference
    • Winsor Index
    • ECG
    • Retinography
    • Blood level of (fasting values): total cholesterol, HDL cholesterol, LDL cholesterol, blood sugar, triglycerides, glycated hemoglobin These parameters will be checked again at 3, 6 and 18 months in the two groups.

    Telemedicine group (intervention):

    • Blood sugar (two measurements per week).
    • Body weight (weekly)
    • Blood pressure (weekly) Use of devices that allow the automatic upload of data via wi-fi or web is allowed

    Control group (control):

    Routine appointments scheduled by their GPs and specialists in outpatient clinics to record blood sugar levels as per standard GP or specialist physician's indications.

    Blood sugar level is measured in mg/dl in a drop of capillary blood with the use of standard glucose meter

Study groups in NCT04038528
Study groupRoleWhat they receive
Telemedicine GroupPatients in this group monitor blood sugar levels at home and upload their data through a telemedicine systems.
Receives: Behavioral: telemonitoring of T2DM
Control GroupThe control group will attend their routine appointments scheduled by their GPs and specialists in outpatient clinics and will record blood sugar levels according to the traditional method as per GP or specialist physician's indications.

What is being measured

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

  1. glycated hemoglobin (GlyH) level

    Level of glycated hemoglobin (GlyH) at the end of the study (18 months) in patients followed with telemedicine and in the control group when compared to baseline, with normal GlyH defined as <5.6%.

    Measured: 18 months

Secondary outcomes (9)

  1. Quality of life perception

    Quality of life as perceived by the patients measured using the SF-36 questionnaire at baseline, 6 months and at the end of the study (18 months)

    Measured: 18 months

  2. Body mass index (BMI)

    BMI calculated from height and weight at baseline and at the end of the study

    Measured: 18 months

  3. Abdominal circumference

    Difference in the abdominal circumference measured at baseline and at the end of the study

    Measured: 18 months

  4. Triglyceride

    Blood triglyceride level at baseline and at the end of the study

    Measured: 18 months

  5. LDL-cholesterol

    Blood LDL-cholesterol level at baseline and at the end of the study

    Measured: 18 months

  6. Systolic Blood Pressure (BP)

    Systolic BP at baseline and at the end of the study

    Measured: 18 months

  7. Diastolic BP

    Diastolic blood pressure at baseline and at the end of the study

    Measured: 18 months

  8. Compliance

    Compliance with blood glucose testing (number of actual measurements/expected number of measurements in the whole timeframe of the study), with participants divided into four groups: poor (<50%), mediocre (50-70%), good (70-90%), optimal (90-100%)

    Measured: 18 months

  9. Hyperglycemic events

    Number of hyperglycemic events during the timeframe of the testing, defined as a spot measure of fasting blood sugar >300 mg/dl

    Measured: 18 months

Timeline

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

  1. First posted31 Jul 2019
  2. Study start1 Mar 2018
  3. Primary completion1 Mar 2020 (estimated)
  4. Study completion31 Jul 2020 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04038528
Sponsor's protocol ID
2018-DC-2-0
Status last verified
Jul 2019
First submitted
23 Jul 2019
Last updated
31 Jul 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets generated during and/or analysed during the current study will be available upon request from DIGITCAL (digitcal01@gmail.com). Anonymised data will be made available to recognised research institutions for research purposes. Written request is required, and data will be shared after approval of the scientific and ethical committees of DIGITCAL. Criteria for data sharing are under discussion at the moment.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Centro Studi Internazionali, Italy at 1 site in Italy.

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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Jul 2019. 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 Italy. 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?

Results are not available in the source record.

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?

glycated hemoglobin (GlyH) level (time frame: 18 months). 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 NCT04038528.

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 31 Jul 2019.

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