Informations générales (source: ClinicalTrials.gov)
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump. The CLOSE Study (CLOSE)
Interventional
N/A
Air Liquide Santé International (Voir sur ClinicalTrials)
septembre 2017
mars 2018
29 juin 2024
This study aims at describing the glucose level by automated glucose sensors and
correlating it with insulin delivery and meals over 14 days in insulin-requiring T2D
patients living in real-life conditions.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Caen, Service Endocrinologie, Diabétologie - 14033 - Caen - France | Yves Reznik, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Selection criteria:
- Type 2 Diabetes diagnosed for at least 5 years
- Treated with insulin pump for at least 6 months
- 7.5% ≤ HBA1c ≤ 10% (last available value dated less than 3 months)
- Having given his/her free, express and informed consent to participate to the study
Inclusion Criteria:
- 7.5% ≤ HBA1c ≤ 10% (result of the dosage performed at selection visit)
- Daily insulin requirement ≤ 1.5U/kg/day
- Having been compliant to take pictures of his/her meals and snacks over the 3 days
prior to the inclusion visit
Non-selection/Non-inclusion criteria:
- Pregnant or breastfeeding woman
- Comorbidity which, in the investigator's opinion, could jeopardize the study
completion
- Patient with difficulties to understand the study procedures or deemed unfit, by the
Investigator, to comply with operating instructions of CGM equipment.
- Type 2 Diabetes diagnosed for at least 5 years
- Treated with insulin pump for at least 6 months
- 7.5% ≤ HBA1c ≤ 10% (last available value dated less than 3 months)
- Having given his/her free, express and informed consent to participate to the study
Inclusion Criteria:
- 7.5% ≤ HBA1c ≤ 10% (result of the dosage performed at selection visit)
- Daily insulin requirement ≤ 1.5U/kg/day
- Having been compliant to take pictures of his/her meals and snacks over the 3 days
prior to the inclusion visit
Non-selection/Non-inclusion criteria:
- Pregnant or breastfeeding woman
- Comorbidity which, in the investigator's opinion, could jeopardize the study
completion
- Patient with difficulties to understand the study procedures or deemed unfit, by the
Investigator, to comply with operating instructions of CGM equipment.