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 investigators 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
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