Holding the Horses of Insulin Pump Infusion: Usage

and Effectiveness of the Low Glucose Suspend

Feature During Fasting in Ramadan Among
Adolescents With Type 1 Diabetes Mellitus to
Prevent Hypoglycemia
Presented by

Nancy Samir Elbarbary

Assistant Professor of Pediatrics, Pediatric Diabetes and
Endocrinology Unit
Ain Shams University, Cairo, Egypt

Background
Muslims who fast during Ramadan must abstain
from eating, drinking, use of oral medications,
and smoking from predawn to after sunset;
however, there are no restrictions on food or
fluid intake between sunset and dawn .
Most people consume two meals per day during
this month, one after sunset, referred to in Arabic
as Iftar (breaking of the fast meal), and the other
before dawn, referred to as Suhur (predawn).

Hours of fast during the month of Ramadan Globally

Day hours

24
22
20
18
16
14
12
10
8

6
4
2
0

Obligation: Quran
"O you who believe! Fasting is prescribed for you as it
was prescribed for those before you, that you may
become Al-Muttaqun (the pious).
(Fasting) for a fixed number of days,

but if any

of you is ill or on a journey, the same number

(should be made up) from other days. And as for those
who can fast with difficulty, (i.e. an old man, etc.), they
have (a choice either to fast or) to feed a poor person
(for every day). But whoever does good of his own
accord, it is better for him. And that you fast, it is better
for you if only you know." (2:183-84)
"The month of Ramadan in which was revealed the
Quran, a guidance for mankind and clear proofs for the
guidance and the criterion (between right and wrong).
So whoever of you sights (the crescent on the first night
of) the month (of Ramadan), he must fast that month,
and whoever is ill or on a journey, the same number (of
days which one did not fast must be made up) from
other days.
Allah intends for you ease, and He does not want to
make things difficult for you. (He wants that you) must
complete the same number (of days), and that you
must magnify Allah for having guided you so that you
may be grateful to Him" (2: 185).

Background

Although the sick are exempted

(Holy Koran, Al-Bakarah, 183185,
Beshyah 2009 ), many patients,
including those with diabetes,
choose to go ahead with fasting,
often for social and cultural as well
as religious reasons.

Salti IS et al Diabetes Care 27: 2306-2311, 2004

EPI.DIA.R
EPIdemiology of DIAbetes
Ramadan 1422/2001
Salti IS et al Diabetes Care 27: 2306-2311, 2004

13

Diabetes, Fasting, and Ramadan

2001/1422 Epidemiology of Diabetes and
Ramadan (EPIDAR) study on 12,243 people
with diabetes in 13 countries
79% of Type 2 DM fast
43% of Type 1 DM fast
Estimate 40-50 million people with DM observe
the Ramadan fast

Background
The risk of hypoglycemia during the daytime is by far
the most disliked complications as its treatment means
the intake of carbohydrate with resulting premature
breaking of the fast, which induces a sense of guilt and
failure by the faithful patients.
Predictably, there is a general perceived fear by patients
and their healthcare providers about the use of insulin
therapy during Ramadan.

Khalil AB, Beshyah SA, Abu Awad SM, Benbarka MM, Haddad M, Al-Hassan D, Kahwatih M,
Nagelkerke N. Diabetes Technol Ther. Ramadan fasting in diabetes patients on insulin pump
therapy augmented by continuous glucose monitoring: an observational real-life study.2012
Sep;14(9):813-8.

Background
Many therapeutic regimens have been
described on how to adjust the type, dose,
and timing of insulin in those treated with
insulin injections for those in whom fasting
was deemed to be safe.
These regimens represent the collective
clinical opinion and many observational and
or interventional studies.
Al-Arouj M, Assaad-Khalil S, Buse J, Fahdil I, Fahmy M, Hafez S, Hassanein M, Ibrahim MA, et
al.,Recommendations for management of diabetes during Ramadan: update 2010.Diabetes care 2010
Aug;33(8):1895-902.

Background
Continuous subcutaneus insulin infusion (CSII)
using external insulin pumps was first
introduced in the 1970s as a way of achieving
and maintaining strict control of blood glucose
concentrations in type 1 diabetes patients
through more physiological insulinization than
achieved with multiple daily injections (MDI).
Agrawal P, Welsh JB, Kannard B, Askari S, Yang Q, Kaufman FR. Usage and effectiveness of the low glucose
suspend feature of the Medtronic Paradigm Veo insulin pump. J Diabetes Sci Technol. 2011;5(5):113741.

Background
The Medtronic Paradigm Veo System
(Medtronic Minimed, Inc., Northridge, CA)
improves on sensor-augmented pump (SAP)
therapy by addition of the low glucose
suspend (LGS) feature, which allows for
automatic pump suspension for up to 120 min
when a preprogrammed CGM threshold value
is reached.
Agrawal P, Welsh JB, Kannard B, Askari S, Yang Q, Kaufman FR. Usage and effectiveness of the low glucose
suspend feature of the Medtronic Paradigm Veo insulin pump. J Diabetes Sci Technol. 2011;5(5):113741.

LGS function:
which allows for
automatic pump
suspension for up
to 120 min when a
preprogrammed
BG value is
reached.

LGS: Low Glucose Suspend

Background
If the BG value is reached, and in the absence of
intervention, the pump displays an informative
message, sounds a continuous alarm, and begins
a 6 h cycle of no insulin delivery for 120 min
followed by insulin delivery at the previously set
basal rate for 240 min.
The 6 h LGS cycle continues until it is manually
interrupted, at which time normal insulin delivery
is resumed.
Agrawal P, Welsh JB, Kannard B, Askari S, Yang Q, Kaufman FR. Usage and effectiveness of the low glucose
suspend feature of the Medtronic Paradigm Veo insulin pump. J Diabetes Sci Technol. 2011;5(5):113741.

Aim of the Work

To investigate the feasibility of

usage

of sensor-

augmented insulin pump therapy in adolescents with type

1 diabetes during fasting in Ramadan.

To determine whether the number, duration , and degree

of hypoglycemic episodes could be reduced through the
use of LGS feature using a hypoglycemia alert as well as
its efficacy and safety during Ramadan.

Subjects and Methods

Asking type 1 diabetic adolescents and adults

who wished to fast the month of Ramadan

Patients
wished to
fast

N=37

Patients
Wished
not to fast

N=12

Subjects and Methods

Inclusion criteria:

(1)Adolescents already on insulin pump therapy

as defined by the standard pump qualifications for
at least six months .
(2) Patients with good metabolic control.
(3)Those who attended the whole education
sessions two months before fasting , committed to
follow up the given instructions and were able and
willing to perform the required reliable data
collection for the study .

Subjects and Methods

Exclusion criteria:
Patients with recent history of diabetic ketoacidosis( DKA).

Patients who had end-stage renal disease , or other diabetic

microvascular complications .

Those who had recurrent episodes of skin infections.

Patients were excluded if they had more than one episode of
severe hypoglycemia (resulting in coma or seizures or requiring
medical assistance) in the previous 6 months.

Patients who had been hospitalized or had visited the emergency

room for symptoms related to uncontrolled diabetes in the
previous 6 months.

Patients who were pregnant or planning to get pregnant during

the month of Ramadan.

Subjects and Methods

The enrolled patients

Patients
with sensor

Patients
without sensor

Subjects and Methods

All subjects who wished to observe the fast underwent

all of the following two months prior to Ramadan and
then they had weekly visits to be reassessed :

(1) Detailed Questionnaire

Information on demographic characteristics.

Duration of diabetes .
Duration on insulin pump therapy .
Mean daily insulin dose(total, basal and bolus doses).
Days fasted in Ramadan .
Carbohydrate intake (g/day).
Frequency of hypoglycemia .
Episodes of DKAs and emergency hospital visit for diabetes-related
problems before and during the month of Ramadan.

(2) Clinical assessment

Pre-Ramadan

Subjects and Methods

(3) Pre-Ramadan medical assessments, education

and instructions:
Prior to Ramadan, patients received adequate
training and education, particularly with respect
to self-management of diabetes related emergency ,
insulin doses adjustment and corrections ,
checking their infusion rates carefully according to
results of frequent home blood glucose monitoring.

Subjects and Methods

(4) Diet during Ramadan;

The patients were instructed to base their food

consumption on carbohydrate counting to maintain a
constant body mass.
The common practice of ingesting large amounts of foods
rich in carbohydrates and fats, especially at the sunset meal,
should be avoided. Because of the delay in digestion and
absorption, ingestion of foods containing complex
carbohydrates (slow digesting foods) is advisable at the
predawn meal, which should be eaten as late as possible
before the start of the daily fast.

Subjects and Methods

Patients were instructed on using Bolus Wizard calculator for

estimation of their boluses at sunset and sunrise meals as well as if
they received snacks in between both meals. Further, they were
also instructed to use square or dual types of boluses according to
their meal contents.

Subjects and Methods

(5) Blood glucose measurements:

The patients who did not want to wear the sensor were
instructed to measure their blood glucose concentration
every 4 hours during the fasting period , pre-sunset meal,
2hours after, pre-dawn meal, early in the morning and as
needed if they felt unwell using finger stick blood.
They were also instructed to measure ketone
concentrations using a urine dipstick with every blood
glucose concentration >300 mg/dL.
Patients on sensor: download data were processed using
CareLink Personal software .

Subjects and Methods

(6) Exercise:
Normal levels of physical activity should
be
maintained by patients during fasting hours.
However, excessive and vigorous physical activity
may lead to a higher risk of hypoglycemia and
should be avoided, particularly during the few
hours before the sunset meal.

Subjects and Methods

Breaking the fast

Subjects and Methods

Subjects and Methods

(7) Breaking the fast

All patients were instructed that they must always and

immediately end their fast if blood glucose reaches <70
mg/dl (3.9 mmol/l) in any hours after the start of the fast
and to immediately break the fast in case of symptomatic
hypoglycemia (defined as finger stick blood glucose level
<70 mg/dL with symptoms of tremor, altered mental status
and/or confusion, perspiration, or palpitations).

Subjects and Methods

(7)Breaking the fast

If the patients without LGS found that their glucose

reading during fasting was less than 70 mg/dL, the patients
were asked to break the fast right away, stop the pump,
and have some carbohydrates to elevate his plasma
glucose level, and recheck the readings every 15 minutes
until it is found to be rising.

Insulin Pump daily Basal Rates before the month of Ramadan

Insulin

Basal Insulin

00

04

08

12

16

20

24

Insulin Pump Basal Rates during Fasting periods of Ramadan

Insulin

Basal Insulin

00

04

08

12

16

18

20

24

Subjects and Methods

Laboratory investigations

Assessment of mean HbA1C% before and after

Ramadan

 Outcome measures were :

(1) Exposure to hypoglycemia (defined as low
blood glucose level leading to breaking the fast,
and if patients needed a third-party intervention,
it is defined as severe hypoglycemia),
(2) Number of full fasted days that were
completed during the month,
(3) Emergency hospital visit for diabetes-related
problems.

Results

Results

The enrolled patients

Patients
with sensor

21
16 males and 5 females

Patients
without sensor

16
7 males and 9 females

Enrolled patients on insulin pump

Male
n=23
Age
15.63.3 years
Duration of diabetes

4.94.2 years
pump therapy
1.81.1 years

Female
n= 14
Without
sensor

43%

With sensor
57%

Results
Clinical and laboratory characteristics of enrolled patients
Variable
Age (years), mean SD
Sex, n (%)
Male
Female
Weight (kg), mean SD
Height (cm), mean SD
BMI(Kg/m), mean SD
Duration of diabetes(years)
Months on pump therapy(years)
Average BG (mg/dL), mean SD
HbA1c before Ramadan (%)
HbA1c after Ramadan (%)
Daily insulin dose (IU)
Total
Basal
Bolus

Patients with
sensor (n=21)
16.1 2.5

Patients without
sensor (n= 16)

p value

15.2 4.2

0.706

0.832
16(76)
5 (24)
56.7 19.6
162.6 11.3
21.8 2.3
5.22.3
2.2 1.5
158.6 35.1
7.20.9
7.6 1.3
5119.3
33.69.9
1812.1

7(44)
9(56)

52.3 21.3
158.1 14.4
20.8 2.7
4.62.8
1.6 1.1
169.4 41.2

7.50.7
7.8 0.8
4822.6
318.8
1714.4

0.482
0.136
0.142
0.121
1.0
0.23
0.61

0.30
0.76
0.42
0.573

Results

Characteristics of sensor in patients with LGS

feature on
Variable

Patients with
sensor (n=21)

Total number of LGS

in the whole month

2.314 LGS
alerts

Number of LGS/day

3.6 1.2
per pt/day

Sensor Wear (%)

83.2 8.36

Sensor Life (days)

4.2 1.72

Calibration
Frequency

3.8 1.20

Timings of daytime hypoglycemia

hypoglycemia frequency (%)

4-7pm
12-4pm

8am-12pm
3 am-8 am

Afternoon hypoglycemia

Low Glucose suspend time interval

40
35
30
25
20
15
10
5
0

Time of LGS
interruption (min)

Results

Sensor Glucose Values during LGS Events

Results

Hypoglycemic events in patients on insulin pump

(P<0.001)

Results

AUC for Hypoglycemia during day time

of fasting (p<0.001 for all)

Results

AUC for Hyperglycemia during day

of fasting(P=0.03)

Results

Time for Hypoglycemia and Hyperglycemia

(mg/dl/day(min) during day time
of fasting (p=0.002 and p=0.34)

Days fasted during the month of Ramadan

100
90
80
70
60
50
40
30
20
10
0

Number of patients who

fasted the whole month

P=0.02
Patients
Patients
with
without
sensor
sensor

Number of days patients broke their

fast
4
3,5
3

Number of patients

2,5
2
1,5
1
0,5
0
2 days

4 days

6 days

Results
Clinical and laboratory characteristics of enrolled patients
Variable
Age (years), mean SD
Sex, n (%)
Male
Female
Weight (kg), mean SD
Height (cm), mean SD
BMI(Kg/m), mean SD
Duration of diabetes(years)
Months on pump therapy(years)
Average BG (mg/dL), mean SD
HbA1c before Ramadan (%)
HbA1c after Ramadan (%)
Daily insulin dose (IU)
Total
Basal
Bolus

Patients with
sensor (n=21)
16.1 2.5

Patients without
sensor (n= 16)

p value

15.2 4.2

0.706

0.832
16(76)
5 (24)
56.7 19.6
162.6 11.3
21.8 2.3
5.22.3
2.2 1.5
158.6 35.1
7.20.9
7.6 1.3
5119.3
33.69.9
1812.1

7(44)
9(56)

52.3 21.3
158.1 14.4
20.8 2.7
4.62.8
1.6 1.1
169.4 41.2

7.50.7
7.8 0.8
4822.6
318.8
1714.4

0.482
0.136
0.142
0.121
1.0
0.23
0.61

0.30
0.76
0.42
0.573

Results
Clinical and laboratory characteristics of enrolled patients

Variable
HbA1c before Ramadan (%)
HbA1c after Ramadan (%)
Daily insulin dose (IU)
Total
Basal
Bolus

Patients with Patients without

sensor (n=21) sensor (n= 16)
7.20.9
7.50.7
7.6 1.3
7.8 0.8
5119.3
4822.6
33.69.9
1812.1

318.8
1714.4

p value
0.61

0.30
0.76
0.42
0.573

Adverse Events
No severe hypoglycemic episodes were
reported that required IV glucose or IM
glucagon administration.

Adverse Events
None of the patients developed ketoacidosis
or emergency hospital visits were observed in
both groups .

Conclusions

Conclusions

Sensor-augmented insulin pump therapy with

automated low-glucose insulin suspension has the
potential to reduce exposure to major
hypoglycemic events in patients with type 1
diabetes during Ramadan requiring breaking the
fast without compromising safety.

Conclusions

Fasting was feasible and patients maintained their

glycemic control with adequate education
counseling and nutritional support .
Multicenter, controlled trials are needed to further
research this issue and provide useful clinical
guidelines for best adjustments in pump protocols
during fasting in Ramadan.

Fasting in
Ramadan

Faculty of medicine Ain Shams University, Diabetes and Endocrinology

Unit, Department of Pediatrics

Thanks for your attention!