Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration

Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration: Evaluation of a Novel Single-Port Treatment Approach in Type 1 Diabetic Patients During a 1-Day Stay in a Clinical Research Center and a 6-Day Period at Home

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02359617

Enrollment

Registered

2015-02-10

Start date

2013-02-28

Completion date

2015-03-31

Last updated

2015-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

continuous glucose sensor, subcutaneous insulin infusion, closed-loop glucose control, type 1 diabetes

Brief summary

The study seeks to evaluate a novel treatment approach for performing continuous real-time glucose sensing and insulin delivery at the same subcutaneous tissue site.

Detailed description

The treatment of type 1 diabetes usually comprises the measurement of glucose in blood obtained by finger pricking and the administration of insulin via subcutaneous bolus injection or continuous subcutaneous infusion. This study seeks to test a new treatment approach where glucose sensing and insulin administration are combined and performed at a single subcutaneous tissue site (single-port treatment approach). A single-port device consisting of a continuous glucose sensor and an insulin infusion cannula is inserted into the subcutaneous tissue of 10 type-1 diabetes patients and used for insulin infusion and simultaneous glucose sensing over a 7-day period. The performance of the single-port device is assessed by comparing the obtained glucose readings with those of a blood glucose meter and an additionally worn control sensor.

Interventions

DRUGinsulin delivery

Subcutaneous insulin (100 U/ml, NovoRapid®; Novo Nordisk, Bagsvaerd, Denmark) delivery with an insulin pump (Vibe-TM; Animas Corp., West Chester, PA, USA) and an insulin infusion cannula (SOF-SET MICRO QR 6mm; Medtronic MiniMed, USA) placed at the same site as the continuous glucose sensor.

DEVICEglucose sensing

Glucose sensing with a continuous glucose sensor (Dexcom G4 Platinum Sensor; Dexcom Inc., San Diego, USA) placed at the site of subcutaneous insulin delivery.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 18 to 65 years of age, both inclusive * Type 1 diabetes treated with Continuous Subcutaneous Insulin Infusion (CSII) * HbA1C \< 10% * Signed informed consent before any study-related activities

Exclusion criteria

* Severe acute diseases * Clinically overt diabetic complications * Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation * Taking of any vasoactive substances or anticoagulation medication * Diseases of the skin which could interfere with application of the catheters and Sensors as judged by the investigator * Pregnancy, breastfeeding, intention of becoming pregnant or not using adequate contraception. * Increased tendency towards development of hypoglycaemia * Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject * Concurrent participation in another study

Design outcomes

Primary

Measure	Time frame	Description
Mean absolute relative difference between sensor readings and capillary glucose readings	7 days	Mean absolute relative differences calculated by determining the mean of the absolute value of the percentage difference between paired sensor and capillary glucose concentration

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026