NCT03020264

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

November 28, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2020

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

2.6 years

First QC Date

January 9, 2017

Last Update Submit

July 25, 2024

Conditions

Type2 DiabetesElderlyHypoglycemia

Keywords

Type 2 DiabetesHypoglycemiaElderlyInsulinotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • number of events / patient / month of severe hypoglycemia

    1 month

  • Number of hospitalizations due to hypoglycemia

    1 month

  • Number of asymptomatic confirmed (blood glucose value <0.70g / L) hypoglycemia

    1 month

  • Number of hypoglycaemia in elderly patients admitted to EHPAD

    1 month

  • Number of confirmed nocturnal hypoglycaemia (occurring between 0h00-6h00)

    1 month

  • +7 more secondary outcomes

Study Arms (1)

Patients older than 75 years

EXPERIMENTAL

Collection of hypoglycaemia épisodes with the glycemic sensor FREESTYLE Libre Pro

Device: glycemic sensor FREESTYLE Libre Pro

Interventions

glycemic sensor FREESTYLE Libre ProDEVICE

Collection of hypoglycemia episodes with glycemic sensor FREESTYLE Libre Pro

Patients older than 75 years

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU de Nantes

Nantes, Loire Atlantique, 44000, France

Location

CH d'Ancenis

Ancenis, 44150, France

Location

CHU d'Angers

Angers, 49100, France

Location

Hôpital Sud Francilien

Corbeil-Essonnes, 91106, France

Location

CHRU de Lille

Lille, 59037, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CHU de Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

HypoglycemiaDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Bertrand CARIOU, Pr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 13, 2017

Study Start

November 28, 2017

Primary Completion

June 18, 2020

Study Completion

June 18, 2020

Last Updated

July 26, 2024

Record last verified: 2024-07

Locations

FR(7)