Issues with Toddlers
Bruce Buckingham, MD
Developmental Stages
Infancy (0-12 months)
Normal
Developmental
Tasks
T1Diabetes
Management
Priorities
Family Issues
in T1Diabetes
Management
Developing a
trusting
relationship/”bonding
” with primary
caregiver(s)
-Preventing and
treating
hypoglycemia
-Avoiding
extreme
fluctuations in BG
levels
-Coping with
stress
-Sharing the
“burden of care”
to avoid parent
‘burnout’
Toddler (13-26 months)
Normal
Developmental
Tasks
T1Diabetes
Management
Priorities
Family Issues in
T1Diabetes
Management
-Developing a sense
of mastery and
autonomy
-Preventing
hypoglycemia
-Avoiding extreme
fluctuations in BG
levels due to irregular
food intake
-Establishing a
schedule
-Managing the “picky
eater”
-Limit setting and
coping with toddler’s
lack of cooperation
with regimen
-Sharing the ‘burden
of care”
Child 3-7 years old
Normal
Developmental
Tasks
T1Diabetes
Management
Priorities
Family Issues in
T1Diabetes
Management
-Developing initiative
in activities and
confidence in self
-Hypoglycemia
-Unpredictable
appetite & activity
-Positive
reinforcement for
cooperation with
regimen
-Trusting other
caregivers with
diabetes management
-Reassuring child that
diabetes is no one’s
fault
-Educating other
caregivers about
diabetes management
Hypoglycemia in Infancy
• Cannot communicate symptoms of
hypoglycemia
• Infants do not exhibit the classic adrenalin
response to hypoglycemia (shakiness, sweating)
• This age group has the highest risk for seizures
• In infants brain is still developing, so
hypoglycemia results in more adverse
consequences
Toddler years
• Child may refuse to eat
• Temper tantrums are common
• Must distinguish developmental opposition
and hypoglycemia
• Must not be too cautious and interfere
with child’s ability to try out new things
Preschoolers and Early School
Years (3-7)
• Child care providers become more
involved in child care
• Continue with variations in activity and
food intake, making hypoglycemia
avoidance a difficult issue
Blood Glucose Targets
Age 0-5
Glucose
Before
Meals
100-180
Glucose at
Bedtime overnight
110-200
A1c
7.5-8.5
Age 6-11
90-180
100-180
< 8%
Age 12-20
90-130
90-150
< 7%
Novolog Pre vs Post Meal
Danne, Diabetes Care 26:2639, 2003
Frucosamine Levels With Novolog
Pre or Post Meals
Danne, Diabetes Care 26:2639, 2003
Novolog Pharmacodynamics in Toddlers
12
Toddlers
Adults
10
GIR (mg/kg/min)
8
6
4
2
0
0
50
100
150
Time
200
250
300
350
INFANTS - Pump Concerns
•
•
•
•
•
There is little published experience in
this age group
It is often difficult to recognize lows
More difficult to find and train a babysitter
Where to wear the pump
There is less need for stringent (tight)
blood glucose control in this age group
TODDLERS - DM PROBLEMS
(18 months to 3 years)
•
•
•
•
•
•
Appetite and activity levels change daily
Have frequent intercurrent illnesses
Higher insulin sensitivity
Smaller insulin requirements
Longer overnight periods without food
Prone to ketosis within 3-4 hours of
insulin withdrawal (b-OH butyrate
increases at twice the rate of adults)
Preschool (3-5 yrs old)
Helpful Hints
•
•
•
Allow child to make choices (which
finger, where shot is given, CHO snack)
Let them know that diabetes is not a
punishment and they did nothing to
deserve it
Diabetic doll or medical play to work out
concerns
School Years (5-11)
Diabetic Concerns
•
•
•
•
Friends, school and diabetes tasks
need to be integrated
Parents may be overprotective
Food issues with peers and siblings
Some, but not too much, responsibility
is passed onto the child
Hypoglycemia and Children
• Children < 5year at diagnosis: Greater risk of
learning disabilities (1,2)
• Children intensively treated (v. conventional)
performed less accurately on spatial memory tasks
and slower on pattern recognition (3)
• Children with diabetes (v. control) performed less
well on tests of intelligence, attention, long-term
memory, executive function (4)
• History of seizure was associated with lower
verbal and full scale IQ scores (4)
1. Ryan C. Pediatrics 1985; 75:921-927.
2. Bjorgaas M. Paediatr 1997; 86:148-153.
3. Hershey T. Diabetes Care 1999; 22:1318-1324.
4. Northam E, Anderson P, Jacobs R, Hughes M, Warne G, Werther G. Diabetes Care 2001; 24:1541-1546.
Study Design: Timeline
0 Months
Clinic Visit 1
Sensor
1A
2 Months
4 Months
6 Months
Clinic Visit 2
Clinic Visit 3
Clinic Visit 4
Sensor
1B
Two
weeks
later
Sensor
2A
Sensor
2B
Two
weeks
later
Sensor
3A
Sensor
3B
Two
weeks
later
Third pair of runs
is optional
Subjects
Age
(year; mean, SD; range)
Male/Female
Pump/Injection
Duration of Diabetes
(year; mean, SD)
HbA1c (mean, SD)
History of seizure
4.8 ± 1.4
(1.6 to 6.8)
9/10
6/13
2.2 ± 1.4
8.0 ± 0.8%
1
Results
•
•
•
•
19 children enrolled between 12/02 and 7/03
102 runs, (99 were successful, >24 hours of data)
422 days and 319 nights of data collected
Each sensor worn for on average 75.1 ± 25 hours
and provided on average 916 ± 306 glucose values
per run
• Total of 88,865 glucose values collected, of
which 45,310 were between 8 pm and 8 am
CGMS: Function
Mean Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7
Rvalue
0.95
0.94
n=59
0.95
n=96
0.94
n=85
0.94
n=48
0.92
n=15
0.92
n=9
0.93
n=3
MRAD 11.4
12.4
n=97
11.0
n=97
10.4
n=91
8.8
n=85
11.8
n=22
10.4
n=11
8.6
n=6
n = number of days of data
2% of all days were considered non-optimal based on
CGMS software version 3.0 (MRAD >28%)
Glucose Trends: CT
Post-breakfast
excursion
Nocturnal lows
Hypoglycemia Detection: Meter v.
Sensor Episodes
350
Glucose
(mg/dL)
300
Meter glucose
250
Sensor glucose
311
200
150
100
136
130
50
5
0
Mild
Glucose <65 mg/dL
Severe
Glucose ≤ 40 mg/dL
All subjects had
sensor
hypoglycemia, 17
of 19 children had
severe sensor
hypoglycemia
Hypoglycemia: Duration
Duration: 42 ± 52 minutes
44 nights
(14%)
Duration:
30 ± 42
minutes
No Hypoglycemia
Mild Hypoglycemia
62 nights
(20%)
Severe Hypoglycemia
213 nights (67%)
319 nights total
Hypoglycemia Duration and
Frequency
• Duration of hypoglycemia did not differ based on
age (<5, ≥5yr), pump v. MDI, or HbA1c (<8,
≥8.0%)
• Frequency of mild hypoglycemia was higher in
children on the pump (1.1 v. 1.8 episodes per day of
monitoring, p<0.05)
• Frequency of severe hypoglycemia did not differ
based on insulin regimen
• Frequency of mild or severe hypoglycemia did not
differ based on age or HbA1c
Results: Timing of Hypoglycemia
100
90
80
70
60
No. of
50
Episodes
40
30
20
10
0
Severe
Mild
12a-4a 4a-8a 8a-12p 12p- 4p-8p 8p-12a
4p
Time of Day
Postprandial Hyperglycemia
Meal
Breakfast
n=214
Lunch
n=216
Dinner
n=240
1 hour premeal mean
glucose*
3-hour post- Post-meal
meal mean peak
glucose*
glucose*
168 ± 74
244 ± 72
315 ± 73
176 ± 81
197 ± 77
261 ± 87
180 ± 75
189 ± 72
265 ± 81
* mean±SD in mg/dL, calculated by CGMS software version 3.0
Post-breakfast Hyperglycemia
HbA1c < 8.0% HbA1c ≥ 8.0% P-value
(n=9)
(n=10)
Meal Glucose
163 ± 67
193 ± 79
<0.005
Peak Glucose
287 ± 67a
346 ± 60a
<0.0001
Delta glucose
(peak-meal)
Time to peak
(minutes)
123 ± 63
155 ± 83
<0.005
75 ± 41
76 ± 38
NS
a The mean peak glucose values are underestimated as 40 of 218 values were >400 mg/dL, the
upper limit of the sensor; (32 of 40 occurred in children with HbA1c ≥ 8%.)
Pro’s for Pump Use in Toddlers
Flexibility to accommodate unpredictable
food intake and activity
Basal needs can be easily adjusted for
activities, and illness (about 12-23/year)
Parents are in complete control
It is hard to be precise with small doses of
insulin given by syringe
Small doses of NPH insulin have a short
duration of action
Con’s for Pump Use in Toddlers
Toddlers can develop ketoacidosis quickly
Sites could get infected (dirty diapers)
Toddler could remove the pump
Toddler could deliver an insulin bolus
Increased cost of therapy
Inconvenience of wearing a device
Summary of Published Toddler
Pump Studies
Study
Year
n
6
Mean A1c Pre
Age
3 yrs
9.0%
A1c
Post
7.5%
Bougnères
1984
Litton
2002
9
1.5 yrs
9.5%
7.9%
DiMeglio
2004 42 3.8 yrs
8.9%
8.6%
Weinzimer
2005 65 4.5 yrs
7.4%
7.0%
8.1%
7.6%
Mack-Fogg 2005
9
3 yrs
Wilson
2005 19 3.6 yrs
7.9%
7.8%
Fox
2005 11 3.8 yrs
7.4%
7.2%
Insulin Pump Therapy in Toddlers
Litton J Peds 141:490, 2002
9 toddlers
Non-randomized, retrospective study
Compared control for about 1 year prior to
and 1 year following pump initiation
10 toddlers did not qualify
4 due to inadequate parental supervision
 5 had good control on MDI
 1 could not receive insurance coverage for a
pump

Change In A1c After A 12 Months Of Pump
Therapy In Toddlers
Litton, J. Peds 14:490, 2002
Frequency of Severe Hypoglycemia After 12
Months Of Pump Therapy In Toddlers
Litton, J. Peds 14:490, 2002
Benefit of Pump Rx in Toddlers
Weinzimer, Pediatrics 114:1601, 2004
Non-randomized, retrospective study
65 children started on pump therapy
before age 7
Compare values in the 3 months prior to
pump initiation to post pump values
Benefit of Pump Rx in Toddlers
Weinzimer, Pediatrics 114:1601, 2004
Effect of Mother working on A1c changes in
Toddlers
Weinzimer, Pediatrics 114:1601, 2004
Mother at
Home
38
Mother
working
26
A1c Before
7.3
7.5
A1c After
7.1
7.1
P
.02
.002
n
No children received daytime care
by their father
Problems with Non-randomized
Studies
Patient selection bias

Those in poor control
 Can
have a significant Hawthorne effect
 Receive significant teaching and help with pump
initiation
Select for patients who can afford a pump
 Select for those who want a pump

 High
initial motivation
Summary of Published Toddler
Pump Studies
Study
Mean A1c Pre
Age
Bougnères Non
1984
6
3 yrs Trial
9.0%
Randomized
Litton
DiMeglio
Year
n
2002
9 1.5 yrs Trial
9.5%
Non
Randomized
2004 42 3.8 yrs
A1c
Post
7.5%
7.9%
8.9%
8.6%
Weinzimer Non
2005
65 4.5 yrs Trial
7.4%
Randomized
7.0%
Mack-FoggNon
2005
9
3 yrs Trial
8.1%
Randomized
7.6%
Wilson
2005 19 3.6 yrs
7.9%
7.8%
Fox
2005 11 3.8 yrs
7.4%
7.2%
RANDOMIZED, CONTROLLED STUDY OF
INSULIN PUMP THERAPY IN PRESCHOOLERS
DiMeglio, J Pediatr 2004;145:380-4
6 month study
MDI
88% on two injections/d
 12% on three or more injections/d
 59% used NPH insulin
 12% Lente insulin
 6% Glargine

Average of 6 blood tests/day
Randomized Trial of Pump Rx in Toddlers
DiMeglio, J. Peds 145:380, 2004
RANDOMIZED, CONTROLLED STUDY OF
INSULIN PUMP THERAPY IN PRESCHOOLERS
DiMeglio, J Pediatr 2004;145:380-4
Meter Glucose
(mg/dl)
<100
<60
Seizures
DKA
Pump
19%
6%
1
0
MDI
14%
4%
1
0
p
<0.05
0.09
Randomized Prospective Trial
in Toddlers
Fox, Diabetes Care 28:1277, 2005
6 month study
26 subjects (22 completed)
Mean Age 3.8 years
MDI
2.3 injections/d
 100% used NPH insulin

Randomized Prospective Trial
in Toddlers
Fox, Diabetes Care 28:1277, 2005
Randomized Prospective Trial
in Toddlers
Fox, Diabetes Care 28:1277, 2005
Hypoglycemia (#)
before Breakfast Seizures
<80
<60
DKA
Pump
50
24
0
1
MDI
16
3
1
0
<0.01
0.001
p
Randomized Prospective Trial
in Toddlers
Fox, Diabetes Care 28:1277, 2005
No significant difference in the Quality of
Life scale for the parents of children
receiving MDI or Pump therapy
Two Center Randomized Trial
of Pump vs MDI in Toddlers
Wilson, Diabetes Care 2005
Prospective, Randomized Trial
Mean age 3.6 years
Mean Duration of Diabetes 1.4 years
1 year study
All home glucose measurements collected
CGMS at 0, 1, 6 and 12 months
Diabetes Quality of Life Questionnaire at
0, 6, and 12 months
Multiple Daily Insulin Group
Wilson, Diabetes Care 2005
3.4 injections/day
Total daily dose 0.7 u/kg/d
At baseline
3 using Glargine
 5 using Ultralente
 15 were using NPH insulin

At study end

12 using Glargine
Pump Group
Wilson, Diabetes Care 2005
Total Daily Dose = 0.54 units/kg/d
4.8 basal rates/day
Can Novolog be diluted with Novo NPH
buffer?
See Jorgensen. Abstract #416, Monday,
12-2 PM
Glucose Meter Data
Wilson, Diabetes Care 2005
Pump MDI
Glucose
0
4
12
20
28
36
44
52
week
wks
wks
wks
wks
wks
wks
wks
>200
45% 46% 46%
45% 42% 38% 43% 37%
>200
36% 38% 37%
41% 39% 39% 39% 42%
70-200
47% 44% 46%
47% 50% 53% 49% 52%
70-200
54% 53% 53%
50% 51% 53% 53% 57%
<70
8%
10%
9%
7%
8%
9%
8%
11%
<70
11%
9%
11%
9%
10%
7%
8%
7%
Hemoglobin A1c
Hemoglobin A1c (%)
Wilson, Diabetes Care 2005
10
Pump
MDI
9
Target
8
7
6
0
10
20
30
Weeks
40
50
Quality of Life
Wilson, Diabetes Care 2005
Quality of Life questionnaire - Questions scored 1 (very
satisfied) to 5 (very dissatisfied) – lower score denotes
improvement
4
lower is better
Quality of Life
5
Pump
MDI
3
2
1
0
10
20
30
Weeks
40
50
Con’s for Pump Use in Toddlers
Toddlers can develop ketoacidosis quickly
Sites could get infected (dirty diapers)
Toddler could remove the pump
Toddler could deliver an insulin bolus
Increased cost of therapy
Inconvenience of wearing a device
Considerations for
Pumps in Toddlers
• Strong parental motivation
• Consistent and continuous supervision
of toddler
• Frequent blood glucose monitoring
• Using an insulin to carb ratio and bg
correction factor
BDC Pump Process
•
•
•
•
•
•
Pump Evaluation
Pump Basics Class
Pump Initiation Class
Saline Start
Insulin Start
Advanced Pump Class
BDC Pumpers < 6 years
• Toddlers started on pump since
2000: 64
• Current toddlers on pump: 30
* Total patients < 6 years: 203
Kid’s Quotes
“I want to go on a pump because I got
really annoyed with shots because they
hurted sometimes and I had to do them at
places like school.” (6 years)
“”I want to go on a pump so I will be
healthier and live longer.” (4 years)
Parent’s Quotes
“We want to put her on a pump
because the shots are terrible,
she’s a picky eater, we want
better control and quality of
life.”
(Parents of a 4 year old)