Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CGM GUARDIAN 2.
- Who it may be relevant to
- Registry conditions: Hyperglycemia, Hypotension, Shock, Septic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Glycemic imbalances are very common in shock patients admitted to intensive care units. A blood glucose control every 2 hours is routinely performed in patients requiring insulin therapy. In practice, we use a protocol and management software called "CPG" (Personalized Control of Blood Glucose). This involves taking capillary samples from the fingertips. In addition to the pain generated, local haematomas and sensitivity disorders have been described. Night-time sampling also leads to repeated awakenings. The "CGM GUARDIAN 2" system has been validated for the measurement of glucose in interstitial fluid in insulin-dependent diabetic patients. An electrode is placed on the patient's abdomen or arm for up to 6 days. This electrode consists of a needle that is inserted subcutaneously only during the placement. The sugar level is read using a sensor placed on the electrode and an insulin pump (which will not deliver therapy (for our study) and which will be used only as an information reader to know the glucose level and trends). Interstitial fluid is automatically drawn from the electrode every minute and averaged every 5 minutes. This device has not yet been validated in resuscitation patients.
Interventions
- Device CGM GUARDIAN 2
continuous blood glucose monitoring system
Primary outcome measures
- Glucose level [Time frame: Day 6]
Eligibility criteria
Inclusion criteria
- Patient in septic shock
- Arterial hypotension requiring noradrenaline
- Hyperglycaemia requiring insulin therapy
Exclusion criteria
- Patients under guardianship, curatorship or deprived of liberty
- Pregnant or breastfeeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU de Nice — Nice
Identifiers
NCT: NCT04910841 · 19-AOI-10