Feasibility Study of the JewelPump Version 3

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02097316

Enrollment

Registered

2014-03-27

Start date

2014-06-30

Completion date

2014-09-30

Last updated

2014-10-27

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

Conditions

Type 1 Diabetes

Keywords

Glycemic control, JewelPump accuracy

Brief summary

The study will be conducted, in cross-over with a time interval of at least 2 days between 2 treatment periods. Patients will be randomized into 2 groups According to the order of the randomization, patients will bear the JewelPump for 5 days, followed by a period of 5 days of treatment with their usual pumps.

Detailed description

The JewelPump (Debiotech) will be compared to the conventional pumps. Patients will treated with the JewelPump during 5 days, and with their usual pump during 5 other days. The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Strasbourg, and CHRU of Marseille.

Interventions

DEVICEJewelPump

DEVICEusual insulin pump

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients type 1 diabetics treated by external insulin pump; * Patients with HbA1c \< 8.5% * Patients who signed consent

Exclusion criteria

* Patients type 2 diabetics * Patients who have all serious diseases that could interfere with the study

Design outcomes

Primary

Measure	Time frame	Description
Time spent in glycemic area 70-180 mg / dl, measured continuously for 5 days with a continuous glucose monitoring (CGM) DEXCOM G4	up to 5 days of each treatment period	Evaluate the non-inferiority of JewelPump compared to the usual pump patient, on glycemic control.

Secondary

Measure	Time frame	Description
Time spent in the strict glycemic area 80-140 mg / dl	up to 5 days of each treatment period	Evaluate the superiority of JewelPump versus usual pump;

Other

Measure	Time frame
Time spent below 70 mg / dl	up to 5 days in each treatment period
Time spent above 180mg/dl;	up to 5 days in each treatment period

Countries

France

Outcome results

None listed

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