Guido Freckmann, Germany
Institute for Diabetes Technology Management, ResearchModerator of 1 Session
Presenter of 2 Presentations
INSULIN INFUSION SET USE FOR UP TO 7 DAYS: EARLY REPLACEMENT REASONS AND IMPACT ON GLYCEMIC CONTROL IN A PROSPECTIVE STUDY
Abstract
Background and Aims
The evidence for recommendations to change insulin infusion sets (IIS) at least every 2-3 days is limited. In this study, an extended indwelling time of IIS and its impact on glycemic control were investigated.
Methods
Forty subjects were advised to wear IIS for up to 7 days in daily life. Each subject used two YpsoPump® Orbit®soft (soft cannula) and two YpsoPump® Orbit®micro (steel needle) IIS. Early replacements were documented and glucose levels were monitored (Dexcom G5TM Mobile). For IIS surviving 7 days, subjects’ glycemic control was compared between days.
Results
Of 160 tested IIS, 66% were used for 7 days. Mean wearing time was 6.2±1.5 days with no considerable difference between steel and soft cannula IIS. Main early replacements reasons were suspected occlusions (n=30) and adhesive failure (n=7). Mean glucose concentration (n=105 IIS) was 146±21 mg/dl during the first 3 days and 148±18 mg/dl during the whole 7 days and coefficient of variation was 34±7% vs. 33±5%. Daily insulin demand was 40±11 U (day 1-3) vs. 41±11 U (day 1-7). Infusion site reactions were mild and resolved within a few days without treatment. No infusion site infection occurred.
Conclusions
Prolonged indwelling of IIS did not have a clinically relevant impact on glycemic control. IIS tolerability was good and appeared comparable to 3-day use. An individual wearing time of up to 7 days is possible if no obvious reason for earlier change such as occlusion, adhesive failure or inflammation occurs.
Which standards do we need for continuous glucose monitoring (CGM)?
Abstract
Background and Aims
Continuous glucose monitoring (CGM) is increasingly used by in diabetes therapy and is partly replacing self-monitoring of blood glucose (SMBG). However, CGM and SMBG measure glucose in different compartments which are known to exhibit a time lag in glucose concentration. In addition, CGM systems use different calibration procedures and algorithms to calculate glucose values. Studies showed that there can be considerable systematic measurement differences between CGM systems.
Methods
While for SMBG systems an international standard describing test procedures and accuracy criteria is available, there is no international standard for CGM systems established. In addition, CGM glucose values currently cannot be traced to higher order materials or methods because a reference measurement in s.c. tissue is currently not feasible. The major metric, the mean absolute relative deviation (MARD), that is used to describe CGM accuracy, is highly dependent on many factors like study design and therefore only offers limited comparability between systems.
Results
The IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) recently founded a new CGM working group. Objectives are the establishment of traceability for CGM glucose values, definition of procedures for assessment of the analytical performance of CGM system and definition of suitable metrics and acceptance criteria regarding analytical performance.
Conclusions
Considering the increasing importance of CGM in diabetes therapy, standards addressing traceability, testing procedures and acceptance criteria are needed.