Telemedical Devices in the Management of Type 2 Diabetes Mellitus to Improve Diabetic Control and Quality of Life
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
1 other identifier
observational
350
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedJuly 31, 2019
July 1, 2019
2 years
July 23, 2019
July 26, 2019
Conditions
Outcome Measures
Primary Outcomes (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%.
18 months
Secondary Outcomes (9)
Quality of life perception
18 months
Body mass index (BMI)
18 months
Abdominal circumference
18 months
Triglyceride
18 months
LDL-cholesterol
18 months
- +4 more secondary outcomes
Study Arms (2)
Telemedicine Group
Patients in this group monitor blood sugar levels at home and upload their data through a telemedicine systems.
Control Group
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.
Interventions
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
Eligibility Criteria
Adult patients with type 2 diabetes mellitus (T2DM) with diagnosis of DM made at least 1 year before the start of the study
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centro Studi Internazionali, Italylead
- GPI SpAcollaborator
Study Sites (1)
ASP Catanzaro
Catanzaro, 88100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio V Gaddi, MD, PhD
EuroGenLab, Bologna, Italy
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2019
First Posted
July 31, 2019
Study Start
March 1, 2018
Primary Completion
March 1, 2020
Study Completion
July 31, 2020
Last Updated
July 31, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Not decided yet
- Access Criteria
- Not decided yet
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.