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Longitudinal Observations of a Large,

Collaborative Insulin Pump Therapy


Program for Children in Kazakhstan
Gulmira Abduakhassova1, Akmaral Nurbekova2,
Aigul Muratalina3, Meng Mao4, John B. Welsh4,
Larisa Yedigarova4, Francine R. Kaufman4
1.
2.
3.
4.

Medical University Astana, Department of Endocrinology, Astana, Kazakhstan


Kazakh National Medical University, Department of Endocrinology, Almaty, Kazakhstan
Medtronic, Inc., Astana, Kazakhstan
Medtronic, Inc.,, Northridge, United States

Presentation O20
Oral Session III: Diabetes Projects in Developing Countries
September 3, 2014, 15:00-16:30

Disclosures

Drs. Abduakhassova and Nurbekova have


received research support from Medtronic, Inc.

Drs. Mao, Welsh, Yedigarova, and Kaufman


are employees of Medtronic, Inc.

Background
Only a few post-Soviet countries, like Russia and Kazakhstan, have
full state coverage for insulin distribution to children with T1DM
Kazakhstan

Russia

Number of T1DM Children (5-15 y/o)

~1000

27, 000

Number of T1DM Children on Insulin


Pump Therapy Prior to Kazakh
Program

Limited to a
Handful

>1900

Insulin Coverage

100%
Government

Pump & Consumables Coverage

No Available
Program

100%
Government*
Federal
Regional
Charity*

Project Baiterek Insulin Pump Therapy for


Children with T1D in Kazakhstan
Objectives:

To develop a partnership between


the Kazakhstan Ministry of Health,
Industry (Medtronic), and the
Diabetes Association of the Republic
of Kazakhstan to advance diabetes
therapy for children with T1D
To give access to insulin pumps for
790 patients, ages 5 15 years of
age, with patients starting within 1
year
To develop a program to evaluate
outcomes

Challenges at Program Onset


Health Care System

Clinical Monitoring

Physicians
Only 4 trained on pump
therapy prior to program
start
65 additional
endocrinologists needed
training
Nurse involvement minimal
and mainly procedural

Questionable A1c test results

Patients
300 test strips per year
o Poor accuracy in
extreme values
Generally poor glucose
control
o HbA1c levels: 10-14

Expansive geography
16 regions
Sparsely populated
Travel difficult

CareLink not available in


clinics
Lack of computers
Lack of internet

1. Motivated physicians

Positives

2. Centralized, well-functioning government


3. Local Medtronic representation

The Partnership Ministry of Health,


Medtronic, and Physicians
Physicians

Offer Specialized Health Care, Initial


Visit and Follow Up
Determine Pump Settings & Treatment
Adjustments
Collect Data on Outcomes and Adverse
Events

Industry

Provide Pumps & Consumables


Physician & Patient Trainings
Project Monitoring
Publications/Presentations

Government
Funding for 790 insulin pumps
Leading the Project
Project Monitoring

Program Support
Initial training for patients and their parents was provided locally.
Educational brochures for patient education were developed in
Russian language
A1C levels were obtained at the initiation of pump therapy and at
3-month intervals
The industry partner (Medtronic) supplied computers and point-ofcare A1C testing equipment to sites
Ongoing remote monitoring and management were provided
through evaluation of CareLink reports

Patient Accrual and Provider Training


Providers Trained

350

90

300

80

250

70

Number with Training

New Pump Patients

Patient Accrual

200
150
100
50
0

Before Program Start

60

At Program Start

50
40
30

20
10

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan
2012
2013

Rapid recruitment into trial


Over 300 patients enrolled in March 2012

0
Doctors

Nurses

83 physicians, 29 nurses were trained

Status of Study
Currently, 731 children enrolled
607 completed 12 months of therapy
413 have both baseline and 12-month A1C data
294 (71.2%) had baseline A1C values >7.5%
Indicating a low prevalence of meeting age-specific
targets

119 had baseline A1C < 7.5%


due to honeymoon, good control, or erroneous value

Results: Change in A1C Among


Patients with Baseline A1C >7.5%
Asian
(N = 208)

Asian and Non-Asian


(N = 294)
11.5

= -1.13 2.50%

11.5

= -1.24 2.65%

11.0

11.0

10.5

10.5

10.5

10.0
9.5
9.0
8.5

10.45

9.32

10.0
9.5
9.0

10.77

9.53

8.5
8.0

8.0
Baseline

12-Month

71% of all patients (294 of 414)


had baseline A1C >7.5%

= -0.85 2.11%

10.0
9.5
9.0
8.5
8.0

7.5

7.5

Mean A1C (%)

11.0
Mean A1C (%)

Mean A1C (%)

11.5

Non-Asian
(N = 86)

9.69

8.82

Baseline

12-Month

7.5

Baseline

12-Month

74% of Asians
had baseline A1C >7.5%

65% of Non-Asians
had baseline A1C >7.5%

Of the patients with baseline A1C >7.5%,


The mean baseline A1C value was higher among Asians than among Non-Asians (p<0.001)
The mean decrease at 12 months was larger among Asians than among Non-Asians (p=0.001)
The reductions at 12 months were clinically and statistically significant, regardless of ancestry

Results: Rural vs. Urban Patients


with Baseline A1C >7.5%
Rural
(N = 66)

Urban
(N = 228)

11.5

11.5

= -1.10 2.63%
p = 0.001

10.5

10.0
9.5
9.0

9.92

11.02

8.5
8.0

11.0

Mean A1C (%)

Mean A1C (%)

11.0

= -1.13 2.47%
p < 0.001

10.5

10.0
9.5
9.0
8.5

10.28

9.15

8.0

7.5

7.5

Baseline

12-Month

83.5% of Rural patients


had baseline A1C >7.5%

Baseline

12-Month

68.3% of Urban patients


had baseline A1C >7.5%

The percentage of subjects with baseline A1C >7.5% was higher


among Rural patients than among Urban patients (p = 0.008)
Significant reductions in A1C were seen at 12 months in both Rural
and Urban patients

Results: Patients 10 or >10 Years of


Age with Baseline A1C >7.5%
10 years old
(N = 142)

> 10 years old


(N = 152)

11.5

11.5

= -1.43 2.25%
p = 0.001

10.5

10.0
9.5
9.0
8.5

10.06

8.0

8.63

7.5

11.0

Mean A1C (%)

Mean A1C (%)

11.0

= -0.85 2.70%
p < 0.001

10.5

10.0
9.5
9.0

10.81
9.97

8.5
8.0
7.5

Baseline

12-Month

63.4% of patients 10 years old


had baseline A1C >7.5%

Baseline

12-Month

80.4% of patients >10 years old


had baseline A1C >7.5%

The percentage of subjects with baseline A1C >7.5% was lower among
patients 10 years old than among patients >10 years old (p < 0.008)
The magnitude of the reduction was greater among younger patients
Significant reductions in A1C were seen at 12 months in age groups

Conclusions
Introduction of CSII therapy to Kazakh children and adolescents with
T1DM resulted in statistically and clinically significant decreases in A1C.
Among those with baseline A1C >7.5%,
A1C decreases were seen in Asian and Non-Asian populations, suggesting that ethnic
background is not a determinant of successful pump implementation
A1C decreases were seen in urban and rural populations, suggesting that proximity to
specialized care centers is not a requirement for successful pump implementation
Reduction in A1C occurred in patients older and younger than 10 years of age, but the
magnitude of reduction greater in younger children

This collaboration between industry, government, and healthcare


providers can serve as a model for rapid deployment of diabetes
technologies in ethnically and geographically diverse countries
At the present time the program is being expanded to include
children 1-5 and >15 years of age

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