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INSULIN PUMP- EVIDENCE
FROM CURRENT ERA
F.A.Q. FROM PATIENTS AND REFERRING
DOCTORS ANSWERED WITH EVIDENCE
DR. OM J LAKHANI
MD, DNB (ENDO)
CONSULTANT ENDOCRINOLOGIST
ZYDUS HOSPITALS
AHMEDABAD
LEVELS OF EVIDENCE
Level A - A well conducted RCT
and meta-analysis of this RCT
Level B - A well conducted Cohort
study
Level C - Evidence from poorly
controlled or uncontrolled studies
Level E - Expert recommendation
THE PUMP VS CAR
‘THE I CAN’T AFFORD A
PUMP NONSENSE’
A car typically costs around 3-5
lakhs while the pump typically
costs 2-6 lakhs
A car has a running cost of
around Rs. 3000-4000 per month
including fuel and maintenance.
A pump running cost is around
5000 per month
If you can buy afford a car for
yourself and can’t buy a pump for
your T1D child - SHAME ON YOU !
Level of evidence ?
QUESTION 1
Q. I am 26 years old type 1
diabetic. Will use of an insulin
pump improve my glycemic
control ?
2000 study
Open-label randomized crossover
study
Included only Adult patients
Duration of Study was 4 months
in each arm of cross-over
The mean HbA1c with CSII was
7.89 % , while the mean HbA1c
with MDI was 8.24% the difference
was statistically significant
Level of evidence ?
Included 23 RCT on CSII vs MDI
There was a statistically
significant
difference in HbA1c favouring
CSII - weighted mean difference -
0.3% (95% confidence interval -
0.1 to -0.4).
Level of evidence ?
Answer- Yes. Pumps improve
glycemic control in Adult patients
with Type 1 Diabetes.
QUESTION 2
Q. My child is 7 year old with type
1 diabetes. Will use of Insulin
pump improve glycemic control in
my child ?
Q. My child is 7 year old with type
1 diabetes. Will use of Insulin
pump improve glycemic control in
my child ?
Randomized Cross-over trial
Patients were on CSII or MDI for
3.5 months each
Glycemic control was similar in
both CSII and MDI
Level of evidence ?
In studies that included
participants less than 18 years of
age the mean difference of
HbA1c was estimated to be -
0.2%(95%CI -0.4 to -0.03) in favour
of CSII compared with MI.
Level of evidence ?
Answer: In Children with T1D, the
use of CSII has mixed evidence
over MDI in terms of HbA1c
Reduction though Meta-analysis
does favour CSII
QUESTION 3
Q. Does the use of the newer
Sensor Augmented Insulin pump
have further benefit for HbA1c
reduction ?
RCT, compared MDI vs Sensor-
augmented CSII in more than 400
participants
Both Adults and Children
included
Follow-up was for 1 year
At 1 year, the baseline mean
glycated hemoglobin level (8.3%
in the two study groups) had
decreased to 7.5% in the pump-
therapy group, as compared with
8.1% in the injection-therapy
group (P<0.001).
An Extension cross-over study (6
months extension) showed
continued benefit for those
already on pump and those
switched from MDI to Pump
Answer- The newer sensor
augmented insulin pumps
produce significant HbA1c
reduction.
Level of evidence ?
QUESTION 4
Q. Will the use of Insulin pump
reduce the risk of Diabetic
Microvascular complications in in
patients having type 1 diabetes ?
This was a prospective cohort
study involving >900 participants
with T1D
Patients treated with CSII or MDI
for atleast 12 months
The Mean HbA1c in both the
groups was similar.
Around 8.6%
Though pumps lead to lower risk
of Microvascular complications -
the difference was not statistically
significant
However, in a multivariate
analysis when confounding
factors were (Higher HbA1c at
beginning of treatment, older age,
longer duration of disease) were
factored in the analysis- the risk
of microvascular complications
was lower in the CSII group.
Level of evidence ?
Answer- Insulin pumps reduce the
risk of microvascular
complications over and above
MDI- despite similar HbA1c !
Q. Why is it that despite similar
reduction in HbA1c, pumps
reduce the risk of Microvascular
complications ?
A specific subgroup analysis of
STAR3 trial
Independent CGM was performed
in the beginning of the trial and at
the end of 1 year of the trial
The study found that SD and CV
calculated from the CGM values
was lower in the pump group vs
the MDI group when the HbA1c
was <8%
Level of evidence ?
QUESTION 5
Q. Will use of a pump reduce the
risk of hypoglycaemia ?
Non-severe hypoglycemia- the
Cochrane study found similar risk
of Non-severe hypoglycaemia in
MDI vs CSII
Severe hypoglycaemia - the data
was not enough for meta-analysis
Level of evidence ?
This is an Cross-over RCT which
compared the use of bio
hormonal bionic pancreas with
conventional insulin pump for 5
days
The mean frequency of
interventions for hypoglycemia
among the adolescents was lower
during the bionic-pancreas period
than during the control period
Among the adults, the bionic
pancreas, as compared with their
usual care, reduced the time that
glucose levels were below 60
mg/dl by 67% (by 94% during the
overnight period).
Level of evidence ?
Answer- Insulin pumps do not
reduce the risk of Hypoglycaemia
- this holds true for both mild as
well as severe hypoglycaemia.
Biohormonal bionic pancreas may
have advantage in this area.
QUESTION 6
Q. Does the use of Insulin pump
reduce the risk of admission due
to Diabetic ketoacidosis ?
Large retrospective observational
study from a Danish T1D registry
Risk of DKA was similar in CSII vs
MDI users
However in those clinics having
more than 250 CSII users- the risk
of DKA was significantly lower
Level of evidence ?
Answer- the risk of DKA is lower
with CSII amongst experienced
users. In general the risk is
similar to MDI
QUESTION 7
A question which NOBODY asks
in India
Q. Will the use of Insulin pump
improve the quality of life ?
Multi-centre RCT conducted
across 5 nations
The overall score of the diabetes
quality of life questionnaire was
higher for CSII (P < 0.001)
There was an improvement in
pump users' perception of mental
health was detected when using
the SF-12 questionnaire (P < 0.05).
Level of evidence ?
Answer- Insulin pumps
undoubtedly improve the quality
of life amongst patients with T1D
Q. What specific advantage will
my child have when he uses
Insulin pump ?
TAKE HOME MESSAGES
Insulin pumps improve Glycemic
control in Adults with T1D
They may have benefit in children
as well for glycemic control
Insulin pumps reduce the risk of
Microvascular complications
Pumps reduce glycemic
variability
The risk of hypoglycaemia is
similar in both MDI vs CSII
The risk of Diabetic ketoacidosis
is similar in MDI vs CSII
Insulin pumps improve the quality
of life
Buy a pump for your child today -
it would improve his/her life.
THANK YOU !

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