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

Use of telemedical models and devices in the home management of type 2 diabetes mellitus to improve diabetic control - measured as blood sugar and glycated hemoglobin levels - and the patients' perceived quality of life

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15790927

Enrollment

350

Registered

2019-01-25

Start date

2018-07-01

Completion date

Unknown

Last updated

2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus (T2DM) Nutritional, Metabolic, Endocrine

Interventions

Researchers perform a general examination at baseline and measure the following parameters (baseline values) and perform the following investigations for all participants (T2DM adult patients enrolled

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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%.	—

Secondary

Measure	Time frame
1. 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) 2. BMI calculated from height and weight at baseline and at the end of the study (18 months) 3. Abdominal circumference at baseline and at the end of the study (18 months) 4. Blood triglyceride level at baseline and at the end of the study (18 months) 5. Blood LDL-cholesterol level at baseline and at the end of the study (18 months) 6. Systolic blood pressure at baseline and at the end of the study (18 months) 7. Diastolic blood pressure at baseline and at the end of the study (18 months) 8. Compliance with blood glucose testing, with participants divided into four groups: poor (300 mg/dl	—

Measure

Time frame

1. 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) 2. BMI calculated from height and weight at baseline and at the end of the study (18 months) 3. Abdominal circumference at baseline and at the end of the study (18 months) 4. Blood triglyceride level at baseline and at the end of the study (18 months) 5. Blood LDL-cholesterol level at baseline and at the end of the study (18 months) 6. Systolic blood pressure at baseline and at the end of the study (18 months) 7. Diastolic blood pressure at baseline and at the end of the study (18 months) 8. Compliance with blood glucose testing, with participants divided into four groups: poor (300 mg/dl

—

Countries

Italy

Contacts

Public ContactMaurizio;Antonio Vittorino Cipolla;Gaddi

;

cipolla.maurizio54@gmail.com;+39 3351368613;

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026