Status:
COMPLETED
Assess the Impact of Insulclock on Glycemic Variability and Treatment Compliance in Uncontrolled DM1 Patients
Lead Sponsor:
Hospital General de Segovia
Collaborating Sponsors:
Insulcloud S.L.
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
14-80 years
Phase:
NA
Brief Summary
Insulclock® is a small electronic device developed to facilitate the optimal administration of insulin. This device works as an add-on module of commercially available insulin pens and monitors the da...
Detailed Description
Study design: This multicentric randomized open-label study will be conducted at the Hospital General de Segovia (Segovia, Spain), Hospital de Cruces (Bilbao, Spain), Hospital Arquitecto Marcide (Fer...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04847778
Start Date
March 1 2021
End Date
July 31 2021
Last Update
March 11 2022
Active Locations (4)
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1
Endocrinology and Nutrition Unit, Arquitecto Marcide Hospital
Ferrol, A Coruña, Spain, 15405
2
Endocrinology and Nutrition Service, Hospital de Cruces.
Bilbao, Spain, 48903
3
Endocrinology and Nutrition Service, Hospital Central de Asturias
Oviedo, Spain, 33011
4
Endocrinology and Nutrition Unit /Diabetes Unit, Hospital General de Segovia
Segovia, Spain, 40002