Assess the Impact of Insulclock on Glycemic Variability and Treatment Compliance in Uncontrolled DM1 Patients

NACompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

June 30, 2021

Study Completion Date

July 31, 2021

Conditions
Diabetes Mellitus, Type 1
Interventions
DEVICE

Use of Insulclock system, both Insulclock device and Insulclock 360 app.

"Visit 5, during week 4.~Randomization will be applied:~Active group will use all functionalities of Insulclock 360. They will have reminders, all their information and statistics at the disposition of the patient and healthcare providers, they have the assistance if desired of an ally or caregiver, a bolus calculator and the rest of functionalities described in the protocol."

DEVICE

Use of Insulclock system, both Insulclock device and Insulclock app on masked mode.

"Visit 5, during week 4.~Randomization will be applied:~Masked group will remain with the masked system, without functionalities."

Trial Locations (4)

15405

Endocrinology and Nutrition Unit, Arquitecto Marcide Hospital, Ferrol

33011

Endocrinology and Nutrition Service, Hospital Central de Asturias, Oviedo

40002

Endocrinology and Nutrition Unit /Diabetes Unit, Hospital General de Segovia, Segovia

48903

Endocrinology and Nutrition Service, Hospital de Cruces., Bilbao

All Listed Sponsors
collaborator

Insulcloud S.L.

INDUSTRY

lead

Hospital General de Segovia

OTHER

NCT04847778 - Assess the Impact of Insulclock on Glycemic Variability and Treatment Compliance in Uncontrolled DM1 Patients | Biotech Hunter | Biotech Hunter