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

NCT04081883 | Completed

• 2 other identifiers: CHUBX 2018/482019-A01837-50
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Continuous Glucose Monitoring; Biosensor

Outcome Measures

Primary Outcomes (1)

• 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.

  2 days after inclusion

Study Arms (1)

Biosensor algorithm

EXPERIMENTAL

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

Other: Biosensor algorithm

Interventions

Biosensor algorithm OTHER

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.

Biosensor algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hôpital Saint-André

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bogdan CATARGI, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 9, 2019
• Study Start: January 27, 2023
• Primary Completion: January 27, 2024
• Study Completion: January 27, 2024
• Last Updated: May 22, 2026

Record last verified: 2024-03

Locations

FR (1)