Clinical trial NCT04038528: Telemedical Devices in the Management of Type 2 Diabetes Mellitus to Improve Diabetic Control and Quality of Life
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Centro Studi Internazionali, Italy
Sponsor class: NETWORK
Collaborators: name: GPI SpA
First posted: 2019-07-31
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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 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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: glycated hemoglobin (GlyH) level
timeFrame: 18 months
Secondary outcomes:
measure: Quality of life perception
timeFrame: 18 months
measure: Body mass index (BMI)
timeFrame: 18 months
measure: Abdominal circumference
timeFrame: 18 months
measure: Triglyceride
timeFrame: 18 months
measure: LDL-cholesterol
timeFrame: 18 months
measure: Systolic Blood Pressure (BP)
timeFrame: 18 months
measure: Diastolic BP
timeFrame: 18 months
measure: Compliance
timeFrame: 18 months
measure: Hyperglycemic events
timeFrame: 18 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: ASP Catanzaro
Study officials:
affiliation: EuroGenLab, Bologna, Italy
name: Antonio V Gaddi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: