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Background. Self-monitoring with a blood glucose meter is useful but limited:Patient adherence/nocturnal glycaemia/post-prandial periodIsolated glycaemic valuesDoes not access asymptomatic hypoglycaemiasHbA1c interpretation:Limited in some situations (ex: anaemia, haemolysis, haemoglobin vari
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1. Marta Alves, Celestino Neves, Ana Varela, Cristina Arteiro, Luís Miguel Pereira, Davide Carvalho, José Luís Medina.
Endocrinology Service, S. João Hospital, Faculty of Medicine, University of Porto, Portugal Conclusions: Glycaemic profile obtained with continuous glucose monitoring gives us much more information than conventional methods of blood glucose control assessment. It allows better therapeutical attitudes and improvement of metabolic control, essential for reduction of acute and chronic complications of diabetes.Conclusions: Glycaemic profile obtained with continuous glucose monitoring gives us much more information than conventional methods of blood glucose control assessment. It allows better therapeutical attitudes and improvement of metabolic control, essential for reduction of acute and chronic complications of diabetes.
2. Background
Self-monitoring with a blood glucose meter is useful but limited:
Patient adherence/nocturnal glycaemia/post-prandial period
Isolated glycaemic values
Does not access asymptomatic hypoglycaemias
HbA1c interpretation:
Limited in some situations (ex: anaemia, haemolysis, haemoglobin variants, liver disease)
Reflexes the mean blood glucose levels
Do not able us to correctly interpret the real metabolic control
We need a method that enables us to read the “whole story” Although self-monitoring of blood glucose
plays an important role in achieving target
glycated hemoglobin levels, few patients with type 1
diabetes measure glucose levels after meals or overnight.
Consequently, postprandial hyperglycemia
and asymptomatic nocturnal hypoglycemia are
commonly seen, even in patients with well-controlled
type 1 diabetes who measure blood glucose
several times daily with a home glucose
meter.2-4
Although self-monitoring of blood glucose
plays an important role in achieving target
glycated hemoglobin levels, few patients with type 1
diabetes measure glucose levels after meals or overnight.
Consequently, postprandial hyperglycemia
and asymptomatic nocturnal hypoglycemia are
commonly seen, even in patients with well-controlled
type 1 diabetes who measure blood glucose
several times daily with a home glucose
meter.2-4
3. Background The continuous glucose monitoring system (CGMS), detects fluctuations of glucose levels, informing about direction, magnitude, duration, frequency and its causes, allowing a more realistic perception of glycaemic control. The availability of devices for continuous glucose
monitoring permits the measurement of interstitial
glucose in an ongoing fashion. However,
the first-generation continuous monitors either
provided data only for short-term retrospective
analysis7 or were too difficult and uncomfortable
for clinical use.8 Although not yet as accurate as
blood glucose meters,9,10 newer real-time devices
for continuous glucose monitoring provide improved
accuracy and functionality, such as sounding
alarms when the glucose trend projects future
hypoglycemia, and are better tolerated by users.11
Although short-term or uncontrolled studies have
suggested benefit,11-15 whether these systems help
to produce a sustained lowering of glycated hemoglobin
levels and reduce hypoglycemia in patients
with type 1 diabetes has not been established.
Therefore, in this randomized, multicenter clinical
trial, we evaluated the efficacy and safety of
continuous glucose monitoring in adults and children
with type 1 diabetes.
Patients in the two groups were provided with
written instructions on how to use the data provided
by continuous glucose monitoring and blood
glucose meters to make real-time adjustments of
insulin doses and on the use of computer software
(for those with a home computer) to retrospectively
review the glucose data to alter future insulin
doses.16,17
Patients using a continuous glucose
monitor received additional instructions for modifying
their insulin doses and treatment of hypoglycemia
on the basis of the glucose trend.
Background
The value of continuous glucose monitoring in the management of type 1 diabetes
mellitus has not been determined.
Methods
In a multicenter clinical trial, we randomly assigned 322 adults and children who
were already receiving intensive therapy for type 1 diabetes to a group with continuous
glucose monitoring or to a control group performing home monitoring with a
blood glucose meter. All the patients were stratified into three groups according to
age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was
the change in the glycated hemoglobin level at 26 weeks.
Results
The changes in glycated hemoglobin levels in the two study groups varied markedly
according to age group (P = 0.003), with a significant difference among patients 25
years of age or older that favored the continuous-monitoring group (mean difference
in change, -0.53%; 95% confidence interval [CI], -0.71 to -0.35; P<0.001). The
between-group difference was not significant among those who were 15 to 24 years
of age (mean difference, 0.08; 95% CI, -0.17 to 0.33; P = 0.52) or among those who
were 8 to 14 years of age (mean difference, -0.13; 95% CI, -0.38 to 0.11; P = 0.29).
Secondary glycated hemoglobin outcomes were better in the continuous-monitoring
group than in the control group among the oldest and youngest patients but not
among those who were 15 to 24 years of age. The use of continuous glucose monitoring
averaged 6.0 or more days per week for 83% of patients 25 years of age or
older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The
rate of severe hypoglycemia was low and did not differ between the two study groups;
however, the trial was not powered to detect such a difference.
Conclusions
Continuous glucose monitoring can be associated with improved glycemic control
in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness
of continuous monitoring in children and adolescents. (ClinicalTrials.gov number,
NCT00406133.)
Copyright © 2008 Massachusetts Medical Society. All rights reserved.
Downloaded from www.nejm.org by SUSANA A. FERREIRA MD on November 1, 2008 .
The availability of devices for continuous glucose
monitoring permits the measurement of interstitial
glucose in an ongoing fashion. However,
the first-generation continuous monitors either
provided data only for short-term retrospective
analysis7 or were too difficult and uncomfortable
for clinical use.8 Although not yet as accurate as
blood glucose meters,9,10 newer real-time devices
for continuous glucose monitoring provide improved
accuracy and functionality, such as sounding
alarms when the glucose trend projects future
hypoglycemia, and are better tolerated by users.11
Although short-term or uncontrolled studies have
suggested benefit,11-15 whether these systems help
to produce a sustained lowering of glycated hemoglobin
levels and reduce hypoglycemia in patients
with type 1 diabetes has not been established.
Therefore, in this randomized, multicenter clinical
trial, we evaluated the efficacy and safety of
continuous glucose monitoring in adults and children
with type 1 diabetes.
Patients in the two groups were provided with
written instructions on how to use the data provided
by continuous glucose monitoring and blood
glucose meters to make real-time adjustments of
insulin doses and on the use of computer software
(for those with a home computer) to retrospectively
review the glucose data to alter future insulin
doses.16,17
Patients using a continuous glucose
monitor received additional instructions for modifying
their insulin doses and treatment of hypoglycemia
on the basis of the glucose trend.
Background
The value of continuous glucose monitoring in the management of type 1 diabetes
mellitus has not been determined.
Methods
In a multicenter clinical trial, we randomly assigned 322 adults and children who
were already receiving intensive therapy for type 1 diabetes to a group with continuous
glucose monitoring or to a control group performing home monitoring with a
blood glucose meter. All the patients were stratified into three groups according to
age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was
the change in the glycated hemoglobin level at 26 weeks.
Results
The changes in glycated hemoglobin levels in the two study groups varied markedly
according to age group (P = 0.003), with a significant difference among patients 25
years of age or older that favored the continuous-monitoring group (mean difference
in change, -0.53%; 95% confidence interval [CI], -0.71 to -0.35; P<0.001). The
between-group difference was not significant among those who were 15 to 24 years
of age (mean difference, 0.08; 95% CI, -0.17 to 0.33; P = 0.52) or among those who
were 8 to 14 years of age (mean difference, -0.13; 95% CI, -0.38 to 0.11; P = 0.29).
Secondary glycated hemoglobin outcomes were better in the continuous-monitoring
group than in the control group among the oldest and youngest patients but not
among those who were 15 to 24 years of age. The use of continuous glucose monitoring
averaged 6.0 or more days per week for 83% of patients 25 years of age or
older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The
rate of severe hypoglycemia was low and did not differ between the two study groups;
however, the trial was not powered to detect such a difference.
Conclusions
Continuous glucose monitoring can be associated with improved glycemic control
in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness
of continuous monitoring in children and adolescents. (ClinicalTrials.gov number,
NCT00406133.)
Copyright © 2008 Massachusetts Medical Society. All rights reserved.
Downloaded from www.nejm.org by SUSANA A. FERREIRA MD on November 1, 2008 .
4. Continuous interstitial glucose monitoring
Glucoday® (A. Menarini Diagnostics) is an interstitial glucose monitoring device which allows the knowledge of continuous interstitial glucose concentrations in the subcutaneous tissue.
It uses microdyalisis technique to access interstitial glucose concentration.
Reading of results: each second (record of the mean value each 3 minutes).
Reading limits: 20-600 mg/dL.
Corrigi na, interstitial, knowledgeCorrigi na, interstitial, knowledge
5. Continuous interstitial glucose monitoring system This system was validated in several studies. It was shown a good correlation between interstitial and blood glucose levels.
Boland EA, et al. Diabetes Care 24:1858–1862, 2001.
5 - Gross TM, et al. Diabetes Technol Ther 2:49 – 56, 2000.
Chee W, et al. Endocrinol Metab Clin N Am 33:175-195, 2004.
Jeha GS, et al. Diabetes Care 27:2881-2886, 2004. Corrigi interstitialCorrigi interstitial
6. Objectives To evaluate GlucoDay® potentialities in clinical practice.
To access monitoring parameters of glycaemic control.
To compare HbA1c values before and after knowledge of the monitoring results and consequent institution of adjusted therapeutic measures. Corrigi knowledge, therapeutic Corrigi knowledge, therapeutic
7. Patients and methods The continuous glucose monitoring with the GlucoDay® system, of the A. Menarini Diagnostics was performed in 53 type 1 diabetic patients with:
Poor glucose control
Nocturnal/asymptomatic hypoglycaemias A MCG foi efectuada entre Setembro de 2004 e Março de 2008 em 53 diabéticos tipo 1 da Consulta Externa de Endocrinologia do Hospital de São João que apresentavam:
Mau controlo glicémico
Hipoglicemias nocturnas / assintomáticas
Corrigi bad por Poor; mudei de , para . Na tabela
A MCG foi efectuada entre Setembro de 2004 e Março de 2008 em 53 diabéticos tipo 1 da Consulta Externa de Endocrinologia do Hospital de São João que apresentavam:
Mau controlo glicémico
Hipoglicemias nocturnas / assintomáticas
Corrigi bad por Poor; mudei de , para . Na tabela
8. Patients and methods We evaluated:
the number of episodes of hypoglycaemia <60 mg/dL (3.3 mmol/L)
The number of episodes of hyperglycaemia (values above 200 mg/dl (11.1mmol/L))
the percentage of time in hypoglycaemia
the percentage of time in hyperglycaemia
during the monitoring period (~ 48 hours) Corrigi dL, monitoring Corrigi dL, monitoring
9. Results We found 14,6 ± 10,3 hyperglycaemic episodes and 8,5 ± 9,5 hypoglycaemic episodes in the evaluated patients.
The percentage of time in hyperglycaemia was 35 ± 23.1% and in hypoglycaemia 11,3 ± 15%.
We found 14,6 ± 10,3 hyperglycaemic episodes and 8,5 ± 9,5 hypoglycaemic episodes in the evaluated patients.
The percentage of time in hyperglycaemia was 35 ± 23.1% and in hypoglycaemia 11,3 ± 15%.
13. The day after, with a slight modification in the NPH dosage and a bedtime snack, the hypoglycaemia during the night was eradicated in the second night.
The day after, with a slight modification in the NPH dosage and a bedtime snack, the hypoglycaemia during the night was eradicated in the second night.
14. Average A1c Before and 4 to 10 months after monitorization
Before:
A1c 8.6±1.9%
After:
A1c 7.6±1.2% The average A1c before monitorization was 8,6±1,9% and we could verify a significant reduction in 4 to 10 months after continuous glucose monitorization accomplishment to 7,65±1,2%.
The average A1c before monitorization was 8,6±1,9% and we could verify a significant reduction in 4 to 10 months after continuous glucose monitorization accomplishment to 7,65±1,2%.
15. Conclusions Glycaemic profile obtained with CGMS gives us much more information than conventional methods of blood glucose control assessment.
With continuous interstitial glucose monitoring we may have a better knowledge of the patient glycaemic profile which allows us:
better therapeutic approaches,
improvement of metabolic control
essential to reduce acute and chronic complications of diabetes.
We believe that TRANSIENT INTERSTITIAL GLUCOSE MONITORING IMPROVES GLYCAEMIC CONTROL
