An observational study in Diabetes Mellitus, Type 2, sponsored by Centro Studi Internazionali, Italy. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Centro Studi Internazionali, Italy · Observational
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
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's planned enrollment of 350 is above the median of 233 across 2,218 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Centro Studi Internazionali, Italy is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with type 2 diabetes mellitus (T2DM) with diagnosis of DM made at least 1 year before the start of the study
Exclusion Criteria:
Patients in this group monitor blood sugar levels at home and upload their data through a telemedicine systems.
Behavioral: telemonitoring of T2DM
The 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.
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
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%.
Time frame: 18 months
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)
Time frame: 18 months
Body mass index (BMI)
BMI calculated from height and weight at baseline and at the end of the study
Time frame: 18 months
Abdominal circumference
Difference in the abdominal circumference measured at baseline and at the end of the study
Time frame: 18 months
Triglyceride
Blood triglyceride level at baseline and at the end of the study
Time frame: 18 months
LDL-cholesterol
Blood LDL-cholesterol level at baseline and at the end of the study
Time frame: 18 months
Systolic Blood Pressure (BP)
Systolic BP at baseline and at the end of the study
Time frame: 18 months
Diastolic BP
Diastolic blood pressure at baseline and at the end of the study
Time frame: 18 months
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%)
Time frame: 18 months
Hyperglycemic events
Number of hyperglycemic events during the timeframe of the testing, defined as a spot measure of fasting blood sugar \>300 mg/dl
Time frame: 18 months
Plan to share: 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.
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This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Centro Studi Internazionali, Italy