User Evaluation of the DexCom™ SEVEN.2 Continuous Glucose Monitoring System

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN67042752

Enrollment

Registered

2009-06-29

Start date

2008-12-15

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Type 1 diabetes mellitus Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

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 standa

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026