Assess the Impact of Insulclock on Glycemic Variability and Treatment Compliance in Uncontrolled DM1 Patients (Segoclock2)
Diabetes Mellitus, Type 1
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Type 1 Diabetes Mellitus, Insulin Pen, Glycosylated Hemoglobin, Time in Range, Adherence, Continuous Glucose Monitoring, Insulclock, Basal glycaemia, Preprandial glycaemia, Endocrine System Diseases, Insulin-dependent, Glucose Metabolism Disorders
Eligibility Criteria
Inclusion Criteria:
- age range: 14 to 80 years
- DM1 diagnosed
Patients with type 1 diabetes and poor glycemic control, defined as:
- HbA1c ≥ 6.5% during more than a year
- and/or extreme variations (more than 1% of change in HbA1c in the last 2 years)
- and regular visits to the Endocrinology Unit / Diabetes Unit (more than four each year).
- Signed informed consent form
- Ability of the subjects to use the system and fill the included questionnaires
- Ability and willingness of following and be compatible with the protocol of the clinical trial
Exclusion Criteria:
- Rejection or inability to give the informed consent to participate in the trial.
- Pregnancy or lactation
- Addiction or abuse of alcohol, or history of drug abuse in the last years
- Dementia diagnosis
- Acute infection
- Any illness or condition that, according to investigator, could interfere with the trial
Sites / Locations
- Endocrinology and Nutrition Unit, Arquitecto Marcide Hospital
- Endocrinology and Nutrition Service, Hospital de Cruces.
- Endocrinology and Nutrition Service, Hospital Central de Asturias
- Endocrinology and Nutrition Unit /Diabetes Unit, Hospital General de Segovia
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Masked arm
Active arm
Participants will be instructed on the correct installation and use of the Insulclock device and app on masked mode for recording insulin bolus information. Participants do not receive any other information and will not have access to the Insulclock 360 application from the Internet. Participants will keep administering insulin treatment as usual.
Participants will receive detailed instructions on using the Insuclock 360 app and Insulclock device Participants will be instructed and motivated for full use of all system functions: alarms, messages to the caregivers and investigation team.