NCT03821753

Brief Summary

Revadiab is case-control study aimed to demonstrate that retinal capillary density is altered in patients with type 1 diabetes with glycemic variability compared to those with comparable glycemic control without glycemic variability. An OCT angiography will be used to precisely evaluate retinal capillary density. A secondary objective will be to evaluate if glycemic variability is associated with cognitive dysfunction, using a neuro psychologic evaluation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 7, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2021

Completed
Last Updated

June 10, 2024

Status Verified

November 1, 2018

Enrollment Period

2.5 years

First QC Date

November 26, 2018

Last Update Submit

June 6, 2024

Conditions

Microvascular ComplicationsDiabetic RetinopathyDiabetesMicroangiopathyAngiography

Keywords

Diabetic retinopathyGlycemic variabilityDiabetesMacular retinal microcirculationMicroangiopathyCognitive dysfunction

Outcome Measures

Primary Outcomes (1)

  • Macular capillary density in the external deep capillary network

    Macular capillary density in the external deep capillary network measured by OCT-Angiography (no later than 3 months after inclusion)

    3 months

Secondary Outcomes (14)

  • Macular capillary density in the deep capillary and deep capillary network

    3 months

  • Area of the central avascular zone

    3 months

  • Macular edema presence

    3 months

  • Layer thickness reduction of the ganglion cells

    3 months

  • Diabetic retinopathy stage

    3 months

  • +9 more secondary outcomes

Study Arms (2)

Case

Patients with glycemic variability, defined by a coefficient of variation (CV)\> 43%, calculated from continuous glucose measurements data by Free Style Libre® (Abbott)

Other: Case

Control

Patients without glycemic variability, defined by a coefficient of variation (CV) ≤ 43%, calculated from Free Style Libre® data and matched to patients in the Case group for HbA1c (+/- 0.5%)

Other: Control

Interventions

CaseOTHER

* OCT * OCT-Angiography, * Retinophotography * Neuropsychological tests

Case
ControlOTHER

* OCT * OCT-Angiography, * Retinophotography * Neuropsychological tests

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Inclusion of adult patients with T1D with more than 10 years of diabetes and users of the FreeStyle Free continuous measurement system. Case: Patients with glycemic variability, defined by a coefficient of variation (CV) \> 36%, calculated from continuous glucose measurements data by Free Style Libre® (Abbott). Controls: Patients without glycemic variability, defined by a coefficient of variation (CV) ≤ 36%, calculated from Free Style Libre® data and matched to patients in the Case group for HbA1c (+/- 0.5%).

You may qualify if:

  • Patients ≥ 18 years
  • Type 1 diabetes (T1D)
  • Using Free FreeStyle
  • Diabete evolving for 10 years or more
  • Case: Patients with glycemic variability, defined by a coefficient of variation (CV) \> 36%, calculated from continuous glucose measurements data by Free Style Libre® (Abbott)
  • Controls: Patients without glycemic variability, defined by a coefficient of variation (CV) ≤ 36%, calculated from Free Style Libre® data and matched to patients in the Case group for HbA1c (+/- 0.5%)

You may not qualify if:

  • Type 2 diabetic patient
  • Corticotherapy
  • Comorbidity like cancer
  • Antecedent of vitreoretinal pathology
  • Antecedent of vitreoretinal surgery
  • Important cataract, with an important opacity that prevents a reliable evaluation of capillary density in OCT angio
  • Pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lariboisière

Paris, Île-de-France Region, 75475, France

Location

MeSH Terms

Conditions

Diabetic RetinopathyDiabetes MellitusCognitive Dysfunction

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

January 30, 2019

Study Start

January 7, 2019

Primary Completion

July 8, 2021

Study Completion

July 8, 2021

Last Updated

June 10, 2024

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)