Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03020264
Other study ID # RC16_0351
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 28, 2017
Est. completion date June 18, 2020

Study information

Verified date June 2020
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Diabetes is a chronic and progressive disease that affects nearly 3.5 million people in France.

Currently the investigators are seeing an aging of the population explained by the increase in life expectancy and thus an increasing incidence of diabetes in the elderly. However, the frequency of hypoglycemia in older vulnerable patients remains poorly characterized


Recruitment information / eligibility

Status Terminated
Enrollment 161
Est. completion date June 18, 2020
Est. primary completion date June 18, 2020
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria:

- Male or female = 75 years of age;

- Type 2 diabetes for at least 1 year and treated with insulin for at least 6 months;

- Treated with basal insulin (ie glargine U100: Lantus®, Abasaglar®, glargine U300: Toujeo®, detemir: levemir®, NPH), premix (ie Novomix® and Humalog Mix®), and / Insulin associated or not with one or more oral and / or injectable antidiabetic agents (analog of GLP1...);

- Benefiting from at least 1 capillary glucose per day (carried out by the patient himself or a caregiver);

- Benefiting from a standardized geriatric assessment;

- Signature of informed consent

- Patient benefiting from a social security system.

Exclusion Criteria:

- Male or female aged <75 years;

- Person without diabetes or type 1 diabetes;

- Patient treated only lifestyle modifications and / or oral anti-diabetic drugs and / or GLP-1 receptor agonists alone;

- Subjects with secondary or corticosteroid-induced diabetes;

- Refusal to participate in the study or inability to collect consent;

- Patient for whom follow-up of the study procedures is impossible (glycemic record impossible or insufficient);

- Patient not eligible for geriatric assessment;

- Patient already participating in another study;

- Patient with a severe pathology limiting his life expectancy (palliative care ...) compromising his participation in the study at the discretion of the investigator;

- Patient benefiting from a safeguard of justice.

Study Design


Intervention

Device:
glycemic sensor FREESTYLE Libre Pro
Collection of hypoglycemia episodes with glycemic sensor FREESTYLE Libre Pro

Locations

Country Name City State
France CH d'Ancenis Ancenis
France CHU d'Angers Angers
France Hôpital Sud Francilien Corbeil-Essonnes
France CHRU de Lille Lille
France CHU de Nantes Nantes Loire Atlantique
France CHU de Poitiers Poitiers
France CHU de Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of confirmed or severe hypoglycemia Percentage of patients with at least one episode of confirmed and / or severe hypoglycaemia by measuring capillary blood glucose during 4 weeks of prospective follow-up. 1 month
Secondary number of events / patient / month of severe hypoglycemia Number of confirmed severe hypoglycaemia episodes (events / patient / month), symptomatic or asymptomatic, occurring in patients during 4 weeks of prospective follow-up. 1 month
Secondary Number of hospitalizations due to hypoglycemia Number and duration of hospital stays 1 month
Secondary Number of asymptomatic confirmed (blood glucose value <0.70g / L) hypoglycemia Confirmed asymptomatic hypoglycaemia (events / patient / month) occurring in patients collected with the FREESTYLE Libre Pro glucose sensor 1 month
Secondary Number of hypoglycaemia in elderly patients admitted to EHPAD Confirmed hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients hospitalized in long-term geriatric care sector. 1 month
Secondary Number of confirmed nocturnal hypoglycaemia (occurring between 0h00-6h00) Confirmed nocturnal hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients 1 month
Secondary Number of confirmed hypoglycaemia with a threshold blood glucose value <0.54g / L (neuroglucopenic threshold) Confirmed neuroglucopenic hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients 1 month
Secondary Number of pseudo-hypoglycaemia and unconfirmed hypoglycaemia (Symptoms consistent with hypoglycemia, but with a blood glucose value = 70 mg / dL) Confirmed pseudo-hypoglycaemia and unconfirmed hypoglycaemia (events / patient / month), occurring in patients 1 month
Secondary Score for fear of hypoglycemia in elderly diabetic patients Score for fear of hypoglycaemia (HFS-II) 1 month
Secondary Number of confirmed and severe hypoglycaemia in patients with type 2 diabetes aged 75 years and older in "vigorous" and "vulnerable" subgroups of patients according to a geriatric assessment score Confirmed hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients 1 month
Secondary Number of the transition to ER due to hypoglycemia Number and duration of emergency stays 1 month
Secondary Number of falls due to hypoglycemia Number of falls and loss of autonomy (no home support) 1 month
Secondary Number of death due to hypoglycemia 1 month
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05531396 - Agility Training on Physical Performance, Cognitive Function and Brain Activities in Elderly N/A
Completed NCT03580447 - The Effect of Citrus Extract on Oxidative Stress N/A
Recruiting NCT04096547 - Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
Completed NCT03339791 - Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial N/A
Completed NCT03566719 - Effect of an Exercise Program on Risk of Fall in a Community Dwelling Older Adults N/A
Completed NCT02138968 - Clinical and Economic Assessment of a Pre-frail Screening Program N/A
Completed NCT01368029 - Safety of Lactobacillus Rhamnosus GG Vs. Placebo in Elderly Subjects Receiving Trivalent Inactivated Influenza Vaccine Phase 1
Not yet recruiting NCT01182961 - The Use of Virtual Reality for the Gait Training of Elderly Fallers N/A
Completed NCT00961012 - The Big Squeeze (Lessening the Big Squeeze: The Effect of the Trunk Release on Interface Pressures of Individuals Seated in a High Fowler's Positions) N/A
Completed NCT01899586 - Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly N/A
Completed NCT00748683 - Development of an Integrated Health Care Environment for Elderly With RFID Technology Phase 0
Completed NCT00533065 - Effects of Donepezil on Deficits Associated With Age-Related Decrease of Growth Hormone N/A
Completed NCT00324701 - Telepsychology-Service Delivery for Depressed Elderly Veterans N/A
Completed NCT00798668 - The Body's Response to Food Intake in Trained, Older Adults N/A
Completed NCT00217113 - An Intervention to Preserve Functional Status and Independence Among Community Dwelling Elderly N/A
Completed NCT03666793 - Comprehensive Management of Drug Prescriptions Throughout the Elderly Person's Hospital Care N/A
Recruiting NCT06030804 - Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery N/A
Recruiting NCT05014750 - Frailty of Elderly With Valvular Heart Disease and the Short Term Adverse Events
Completed NCT05021432 - Virtual Reality And Task Oriented Circuit Training Among Elderly Population N/A
Active, not recruiting NCT04132492 - AGNES - Aging Nephropathy Study, a Prospective Observational Cohort of Chronic Kidney Disease in Elderly Patients