search
Back to results

Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump (DIABLO)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biosensor algorithm
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Continuous Glucose Monitoring, Biosensor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient over 18 years of age
  • Patient with type 1 diabetes (T1D)
  • Patient being equipped and trained with an external or internan insulin pump linked to a CGM
  • Affiliated person or beneficiary of a social security scheme
  • Free, informed and written consent

Exclusion Criteria:

  • Patient under 18 years
  • Patient not having T2D
  • Pregnant or lactating patient
  • No consent signed by the patient

Sites / Locations

  • Hôpital Saint-AndréRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biosensor algorithm

Arm Description

The biosensor DIABLO algorithm is compared to Continuous Glucose Monitoring Systems (CGMS) utilisation.

Outcomes

Primary Outcome Measures

Comparison between biosensor to CGMS responses
Measure blood glucose every 10 minutes by taking interstitial fluid from DT1 patients with an internal or external insulin pump to compare the biosensor responses to measurements of standard CGM systems.

Secondary Outcome Measures

Full Information

First Posted
September 4, 2019
Last Updated
May 5, 2023
Sponsor
University Hospital, Bordeaux
search

1. Study Identification

Unique Protocol Identification Number
NCT04081883
Brief Title
Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump
Acronym
DIABLO
Official Title
Decoding Islet Algorithms in Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump Coupled to Sensors.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In T1D, the destruction of beta-pancreatic cells causes insulin deficiency and requires insulin therapy whose control remains complex: even with recent technologies of continuous measurement and monitoring of blood glucose (CGM), current systems are electrochemical, insulin therapy algorithms do not are not optimal and cannot completely eliminate vital risks such as hypoglycemia. A new biosensor connected to the patient by microdialysis, will be tested in a clinical trial in CHU-Bdx on 10 T1D patients with an internal or external insulin pump. In various daily scenarios (meals, physical exercise) the biosensor DIABLO responses will be compared to the measurements of standard CGM systems.
Detailed Description
Continuous monitoring and linked drug delivery is a novel approach to the treatment of chronic diseases that provides powerful means to improve therapeutic outcomes and quality of patient's life. Type 1 diabetes (T1D) concerns 5 to 10% of the estimated 415 million cases of diabetes worldwide in 2016, expected to rise to 642 million by 2040(1). Continuous glucose monitoring systems (CGMS) linked to insulin delivery has provided a major advance(2). T1D is a serious, currently chronic and costly disease in children or young adults. Indeed, the destruction of pancreatic beta-cells leads to absolute insulin deficiency in T1D.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Continuous Glucose Monitoring, Biosensor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biosensor algorithm
Arm Type
Experimental
Arm Description
The biosensor DIABLO algorithm is compared to Continuous Glucose Monitoring Systems (CGMS) utilisation.
Intervention Type
Other
Intervention Name(s)
Biosensor algorithm
Intervention Description
The biosensor DIABLO responses will be compared to the measurements of standard CGMS, using blood glucose measures every 10 minutes by taking interstitial fluid from Diabetes Type 1 (DT1) patients with an internal or external insulin pump.
Primary Outcome Measure Information:
Title
Comparison between biosensor to CGMS responses
Description
Measure blood glucose every 10 minutes by taking interstitial fluid from DT1 patients with an internal or external insulin pump to compare the biosensor responses to measurements of standard CGM systems.
Time Frame
2 days after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient over 18 years of age Patient with type 1 diabetes (T1D) Patient being equipped and trained with an external or internan insulin pump linked to a CGM Affiliated person or beneficiary of a social security scheme Free, informed and written consent Exclusion Criteria: Patient under 18 years Patient not having T2D Pregnant or lactating patient No consent signed by the patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bogdan CATARGI, Pr
Phone
5 57 82 14 10
Ext
+33
Email
bogdan.catargi@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bogdan CATARGI, Pr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Saint-André
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdan CATARGI, Pr
Phone
5 57 82 14 10
Ext
+33
Email
bogdan.catargi@chu-bordeaux.fr

12. IPD Sharing Statement

Learn more about this trial

Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump

We'll reach out to this number within 24 hrs