User Evaluation of the DexCom™ SEVEN.2 Continuous Glucose Monitoring System
| ISRCTN | ISRCTN67042752 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67042752 |
| Secondary identifying numbers | Protocol Nr. 5181 |
- Submission date
- 19/05/2009
- Registration date
- 29/06/2009
- Last edited
- 29/06/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Thomas Danne
Scientific
Scientific
Janusz-Korczak-Allee 12
Hannover
30173
Germany
Study information
| Study design | Single-centre prospective non-randomised masked/un-masked intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | User Evaluation of the DexCom™ SEVEN.2 Continuous Glucose Monitoring System: a single-centre prospective non-randomised masked/un-masked intervention study |
| Study objectives | 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(s) | Ethics Committee of Hannover Medical School approved on the 28th November 2008 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/12/2008 |
| Completion date | 15/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Target enrolment: 55 patients with the aim of 50 completion |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/12/2008 |
| Date of final enrolment | 15/04/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Janusz-Korczak-Allee 12
Hannover
30173
Germany
30173
Germany
Sponsor information
DexCom Inc. (USA)
Industry
Industry
6340 Sequence Drive
San Diego
92121
United States of America
| Website | http://www.dexcom.com |
|---|---|
"ROR" |
https://ror.org/03ra42c27 |
Funders
Funder type
Industry
DexCom Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
