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Clinical Trial Details

Trial ID: L4471
Source ID: NCT02486341
Associated Drug: Insulin
Title: Daily Glycaemic Variability in Frail or Disabled Older Patients With Diabetes Over 75 Treated With Basal Insulin
Acronym: VARQUOGLY
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes
Interventions: DRUG: Insulin
Outcome Measures: Primary: Intraday glycemic variability measured by the average of MAGE index (Mean amplitude of glycemic excursions) everyday of exploitable recording by the participant., 5 days | Secondary: Intraday glycemic variability measured by the average standard deviation of blood glucose every day of exploitable recording by the participant, 5 days|Inter-day glucose variability assessed by Mean Differences of Daily per participant for every day of exploitable recording, 5 days|Average number of diurnal hypoglycaemia defined by blood glucose <0.60g / l from 7am to 22 pm for all exploitable recording days, 5 days|Average number of nocturnal hypoglycemia, defined by blood glucose < 0.60g / l between 22h and 7h for every day of exploitable recording, 5 days|Average time (minutes / day) per day pass in hypoglycemia (<0.60g / l), 5 days|Nutritional status: a composite outcome measure consisting of multiple measures with Mini Nutritional Assessment, calf circumference, abdominal circumference, albumin, At inclusion|Functional Status: a composite outcome measure consisting of multiple measures with scale Rosow and Breslau, Lawton Instrumental Activities of Daily Living Scale, score of Barthel for Activities of Daily Living score evaluation and SPPB Scale, At inclusion|Evaluation of Cognition with Mini Mental Status Examination (MMSE), At inclusion|Fragility level (Rockwood criteria), At inclusion
Sponsor/Collaborators: Sponsor: University Hospital, Bordeaux
Gender: ALL
Age: OLDER_ADULT
Phases:
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2016-03-31
Completion Date: 2019-01-28
Results First Posted:
Last Update Posted: 2020-09-16
Locations: University Hospital of Bordeaux - Xavier Arnozan Hospital, Pessac, 33600, France
URL: https://clinicaltrials.gov/show/NCT02486341