Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/05/2009
Date assigned
29/06/2009
Last edited
29/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Danne

ORCID ID

Contact details

Janusz-Korczak-Allee 12
Hannover
30173
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol Nr. 5181

Study information

Scientific title

User Evaluation of the DexCom™ SEVEN.2 Continuous Glucose Monitoring System: a single-centre prospective non-randomised masked/un-masked intervention study

Acronym

Study hypothesis

The study intends to evaluate user experience with the DexCom™ SEVEN.2 Continuous Glucose Monitoring System in the home environment and the effect of its use on glycaemic control.

Ethics approval

Ethics Committee of Hannover Medical School approved on the 28th November 2008

Study design

Single-centre prospective non-randomised masked/un-masked intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 1 diabetes mellitus

Intervention

During baseline Phase 1 (duration 21 days), subjects will be masked to the display of the DexCom™ SEVEN.2 continuous glucose readings. Subjects will calibrate the DexCom™ SEVEN.2 Receiver using standard fingerstick blood glucose testing with test strips. Subjects will manage their diabetes based upon the blood glucose measurements using their established regimen prescribed by their healthcare professional prior to study enrolment.

At the end of the Phase 1, subjects will return to the clinic to have their DexCom™ SEVEN.2 systems set to display continuous glucose readings and enable low and high glucose alarms. Subjects will continue for the rest of the study using the DexCom™ SEVEN.2 system as an adjunctive device to guide glucose management according to its intended use and warnings given in the User's Guide along with the advice of the study Investigator.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To evaluate improvement in glycaemic variability in children, adolescents, and young adults, particularly in the reduction of the number of hypo- and hyper-glycaemic events, reduction of time spent outside of euglycemia glucose range, and reduction of glucose variability (standard deviation) through use of the DexCom™ SEVEN.2 Continuous Glucose Monitoring System, between masked and un-masked period.

Secondary outcome measures

To evaluate user experience with the DexCom™ SEVEN.2 Continuous Glucose Monitoring System. The HbA1C level will also be evaluated; the unmasked baseline phase A1C will serve as a self-control for the subjects.

Overall trial start date

15/12/2008

Overall trial end date

15/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Documented type 1 diabetes mellitus diagnosis at least 1 year prior to enrolment
2. Recommended to perform daily self-monitoring blood glucose testing
3. Performing multiple daily insulin injections, or has been on an insulin pump, for at least 6 months prior to enrolment
4. Less than 24 years of age, either sex
5. Willing and capable of following the protocol and instructions provided by the investigator
6. Available for the entire study duration of 63 days and for follow up on scheduled study visit days
7. Provided written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Target enrolment: 55 patients with the aim of 50 completion

Participant exclusion criteria

1. Subject has had an episode of severe hypoglycaemia in past four weeks prior to enrolment
2. Allergy to medical grade adhesives
3. Any medical condition or medication, which in the investigator’s opinion, may compromise patient safety
4. Participation in any other study which may affect glucose measurements or glucose management
5. Known, suspected or planning pregnancy during study participation

Recruitment start date

15/12/2008

Recruitment end date

15/04/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Janusz-Korczak-Allee 12
Hannover
30173
Germany

Sponsor information

Organisation

DexCom Inc. (USA)

Sponsor details

6340 Sequence Drive
San Diego
92121
United States of America

Sponsor type

Industry

Website

http://www.dexcom.com

Funders

Funder type

Industry

Funder name

DexCom Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes