The SA Journal Diabetes & Vascular Disease Vol 7 No 4 (November 2010) - page 38

168 VOLUME 7 NUMBER 4 • NOVEMBER 2010
EASD WATCH SA JOURNAL OF DIABETES & VASCULAR DISEASE
tional therapy. The patients were treated
for 2.1 years, according to the protocol,
with an extended follow up of 8.3 years
(median = 4.1 years).
The total mortality was 34%; 72% was
due to cardiovascular disease. Cox regres-
sion analysis did not show any difference
in total or cardiovascular mortality between
the two groups.
The total number of malignancies was
37 patients with the highest number in
group 1. Patients on insulin had a higher
risk of non-fatal events (OR 1.90, p ≤
0.0001) but not of increased mortality.
Metformin was associated with a lower
risk of death as well as a decreased risk of
malignancies.
Body weight increase during the
first year of insulin treatment
in patients with type 2 diabetes
mellitus; a systematic review and
meta-analysis of different insulin
regimens
During the first year of treating type 2 dia-
betes mellitus with insulin, there is a slight
and progressive increase in body weight.
This increase is related to the insulin regi-
men used, basal HbA1c , its changes, and
the frequency of hypoglycaemia.
The aim of the study was to define
body weight increase during the first year
of insulin treatment as a function of treat-
ment modalities. Fifty-one randomised,
parallel group studies with 15 202 patients,
lasting 12–52 weeks, published as full arti-
cles from 1991 to 2009 were included.
Body weight increased by 2.1 ± 0.16 kg.
Body weight increase was directly related
to duration of diabetes, insulin dose, HbA1c
levels, HbA1c changes, glycaemic target,
hypoglycaemia and nocturnal hypoglycae-
mic episodes.
HbA1c FOR DIABETES MELLITUS
DIAGNOSIS: NEED FOR
REASSESSMENT?
A comparison of performance using
two HbA1c cut-off points (a ‘rule-in,
rule-out’ spectrum) and one HbA1c
cut-off point to detect type 2 dia-
betes in a multi-ethnic cohort
The HbA1c level of ≥ 6.5%, used for the
diagnosis of type 2 diabetes, was higher
than the value needed to detect diabetes
mellitus in the groups studied. The use of
a two cut-off-point spectrum to identify
patients suffering from diabetes mellitus
has a better sensitivity and specificity than
a single cut-off point.
In 2010 the American Diabetes Associa-
tion (ADA) recommended that an HbA1c ≥
6.5% can be used as a diagnostic tool for
type 2 diabetes mellitus. Using this single
cut-off point of 6.5% leads to a difference
between the people diagnosed with HbA1c
and those diagnosed using an oral glucose
tolerance test (OGTT).
In the light of the above, it has been
suggested that a two cut-off-point (‘rule-
in, rule-out’) approach be used when using
HbA1c level as a diagnostic test for type 2
diabetes mellitus.
Almost 9 000 previously undiagnosed
primary-care adults between the ages of
40 and 75 years from the LEADER cohort
were included. All patients had undergone
an OGTT and had had an HbA1c measured
between 2002 and 2008. Type 2 diabetes
mellitus was diagnosed using the WHO
1999 diagnostic criteria.
The optimal single cut-off point for
diagnosing diabetes in white Europeans
was ≥ 6.1%, with a sensitivity/specificity of
83.0/87.8%, and for south Asians ≥ 6.3%,
with a sensitivity/specificity of 87.9/85.5%.
An HbA1c value ≤ 5.5% was used to ‘rule
out’ diabetes and an HbA1c value ≥ 7.0%
was used to ‘rule in’ the diagnosis of diabe-
tes. Within the cohort more than 50% of
the patients had an HbA 1c value of between
5.6 and 6.9%, which would necessitate an
OGTT. Better values for the two cut-off-
point spectrum were ≤ 5.8% and ≥ 6.8%,
which would lead to a reduction in the
number of patients needing an OGTT.
Comparison of HbA1c and OGTT in
the diagnosis of diabetes in a high-
risk population: the HUNT-DE-PLAN
study, Norway
The overlap between the patients diag-
nosed using the WHO 1999 criteria and the
newly proposed HbA 1c criteria were poor.
Diagnosis of abnormal glucose
levels in patients at high risk for
the development of diabetes:
a comparison of the OGTT and
measurement of HbA1c following
the American Diabetes Association
recommendations 2010
The oral glucose tolerance test and meas-
urement of HbA1c levels are considered
relevant diagnostic criteria as they corre-
late with the development of retinopathy
and diabetes mellitus. There is a significant
discordance between the HbA1c and OGTT
strategies.
During the study, a third of the patients
with an HbA1c ≥ 6.5% had a normal OGTT.
Haemoglobin A1c in a population
with pre-diabetes, diagnosed, and
previously undiagnosed diabetes
Using a single cut-off HbA1c value ≥ 6.5%
would not diagnose 30% of patients with
previously diagnosed diabetes. In the group
of participants with HbA1c values between
5.7 and 6.9%, 13.9% had diabetes, 30%
had pre-diabetes and more than 50% were
normal.
TREATMENT OF DIABETES
Benefits of sensor-augmented
pump therapy outweigh multiple
daily injections (STAR 3) in type 1
diabetes
The STAR 3 trial of glucose control in adults
during a one-year randomised control trial
compared sensor-augmented pump ther-
apy and multiple daily injection therapy.
This was a multicentre, randomised control
trial which hypothesised that sensor-aug-
mented pump therapy would improve the
HbA1c without increasing hypoglycaemia.
The trial included 329 adult and 156
paediatric patients (with an age between
seven and 18 years) with type I diabetes.
All subjects wore a blinded sensor for six
days at baseline, and the patients in the
multiple daily injection arm wore blinded
sensors for six days at six months and again
at one year.
The primary endpoint of a change
in HbA1c level from baseline to one year
showed a greater decline in the HbA1c levels
in the sensor-augmented pump group com-
pared to the multiple daily injection group.
The difference between the two groups
was a difference in HbA1c of 0.6%, with
a highly significant p-value. This improve-
ment was not associated with an increase
in episodes of severe hypoglycaemia.
There was no difference between the
groups with regard to the incidence of
diabetic keto-acidosis or weight gain. An
interesting finding was that the greater
proportion of patients in the adult group
on sensor-augmented pump therapy
reached the HbA1c target.
The conclusions drawn from this are that
the most benefit from sensor-augmented
pump therapy seemed to be in the older
age group, those who were diagnosed