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DESIGNER INSULINS IN GESTATIONAL DIABETES . DR.T.RAMANI DEVI MD DGO FICS FICOG RAMAKRISHNA NURSING HOME TRICHY. Maternal Diabetes Two lives.. Twice as special An oppurtunity for primary prevention. -Maternal health -Child health. Definition.

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DESIGNER INSULINS IN GESTATIONAL DIABETES


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designer insulins in gestational diabetes

DESIGNER INSULINS IN GESTATIONAL DIABETES

DR.T.RAMANI DEVI MD DGO FICS FICOG

RAMAKRISHNA NURSING HOME

TRICHY

slide2

Maternal Diabetes

Two lives.. Twice as special

An oppurtunity for primary prevention

-Maternal health

-Child health

definition
Definition

GDM is defined as carbohydrate in tolerance of variable severity with onset or first recognition during pregnancy.

The definition is applicable regardless of whether insulin is used to treat the disease or if the condition persists after pregnancy.

It does not exclude the possibility that unrecognized glucose intolerance may have antedated the pregnancy

introduction
Introduction
  • Incidence of GDM is variable from 17% to 29% of all pregnancies
  • Associated with maternal and perinatal complications.
  • 90% of all Diabetics are GDM and 10% are due to pregestational diabetes.
  • 4 million pregnancies in India are complicated by GDM
  • This may contribute a part of MMR in India
gdm prevalence linked to background igt rates

IGT

GDM

GDM prevalence linked to background IGT rates

2%

Agarwal S, Gupta AN. Gestational Diabetes. J Assoc Physicians India 1982;30:203

2%

Ramachandran A, et .al., High prevalence of diabetes in an urban population in south India. BMJ 1988;3; 297(6648):587-90

1980s

7.6%

Narendra J, Munichoodappa C, et al, Prevalence of glucose intolerance during pregnancy. Int J Diab Dev Countries 1991;11:2-4

8.2%

Ramachandran A, Snehalatha c, Dharmaraj D, Viswanathan M. Prevalence of glucose intolerance in Asian Indians. Diabetes Care 1992; 15:1348-55

1990s

14.5%

Ramachandran A, Snehalatha C, Kapur A, Vijay V, Mohan V,Das AK, Rao PV, Yajnik CS, Prasanna Kumar KM, Nair JD.For the Diabetes Epidemiology Study Group in India (DESI).Diabetologia 2001;44:1094-1101.

16.6%

V Seshiah, V Balaji, Madhuri S Balaji, CB Sanjeevi, A. Green. Gestational Diabetes Mellitus in India. J Assoc Physicians India 2004;52:707

2000s

significance of diabetes and pregnancy
Significance of Diabetes and Pregnancy
  • Malformation rate in 94/1000 Vs 9.7/1000 in general population
  • Still birth is 15 times higher 25/1000 Vs 5/1000
  • PNM is 3 times higher 19.9/1000 Vs 6.8/1000
  • Recent concept of adult diseases having their origin inutero insults has been established.
  • 1989 WHO/IDF discussed the problem of hyperglycemia in pregnant women. They wanted to achieve pregnancy outcome in diabetic women same as in non diabetic women.
freinkel hypothesis
FREINKEL HYPOTHESIS

Uterine

At Birth

After Birth

placenta

Macrosomia

Obesity

Hypoglycemia

Maternal DM

Metabolic syndrome

IGT/DM

A Insulin

Fetus

A.A

Fat

CHO

CVD

diabetes and pregnancy why it is relevant

Hyperglycaemia during pregnancy is associated with high risk of maternal and perinatal morbidity and mortality and poor pregnancy outcome

Maternal hyperglycaemia is associated with development of metabolic problems including type 2 diabetes in the offspring

Diagnosis of GDM identifies women at high risk of future diabetes, offers opportunity of primary prevention

Diabetes and Pregnancy – Why it is relevant?
iugr macrosomia
IUGR & Macrosomia

SolutionOptimal nutrition+ Optimal glycemic control=Optimal birth weight 3000 – 3500 g.

slide18

Comparison of the Foetal Outcome in a NGT & GDM

Foetal outcome

Normal

Abortions

Still birth

Died after birth

Congenital anomalies

Premature deliveries

Sick babies

Big baby ( 3.5 kg)

NGT (n = 851)

804

6

3

1

8

9 / 831

22

78

GDM (n =211)

122

0

5

5

5

11 / 148

10

90

P value

< 0.0001

--

0.07

0.01

0.23

0.002

0.157

< 0.0001

how to reduce this
How to reduce this
  • Early screening for GDM
  • Monitoring frequently
  • Proper uses of diet plan , exercise and insulin.
  • Future concepts of CSII, CGMS, telemedicine,

e-health, will revolutionize the management of GDM

how to treat
How to treat?

MNT

Exercise

Insulin

Glyburide

Metformin

Acarbose?

Insulin pump

calorie allotment
Calorie allotment

30 kcal per kg current weight per day in pregnant women who are BMI 22 to 25.

24 kcal per kg current weight per day in overweight pregnant women (BMI 26 to 29).

12 to 15 kcal per kg current weight per day for severely obese pregnant women (BMI >30).

40 kcal per kg current weight per day in pregnant women who are less than BMI 22.

Jovanovic-Peterson L, Peterson, CM. Nutritional management of the obese gestational diabetic woman. J Am CollNutr 1992; 11:246.

how long mnt
How long MNT?

Consensus and hard data are lacking regarding how long diet therapy should be maintained before initiating pharmacologic treatment.

70% of the subjects with initial fasting plasma glucose less than 95 mg/dL achieved targeted levels of glycemia within 2 weeks of dietary management, but no significant improvement occurred thereafter

McFarland et al obstet gynecol 1999

exercise prescription
Exercise Prescription
  • Can continue prepregnancy activity
  • Keeping physically active is essential for good glycemic control
  • Upperbodyergometric exercise useful
  • Do not start new vigorous exercise for glucose control
  • Uterine contractions,fetaltachy, maternal heart rate to be monitored
oral agents in pregnancy

ORAL AGENTS IN PREGNANCY

Glyburide study:

Randomized trial glyburidevs insulin

404 GDMs FPG >95 but <140 mg/dl or 2- hr pp >120 on diet

Similar success of glucose control in both groups

Langer et al: NEJM 200:343:1134

animal insulin insulin analogues
Animal insulin  Insulin Analogues
  • 1920- Introduction of insulin revolutionized Diabetes Management
  • 1920- Introduced insulin had impurities and batch to batch variation
  • 1980- higher quality insulin from bovine and porcine sources . Then came recombinant Insulin
ideal agent should fulfill
IDEAL AGENT SHOULD FULFILL
  • Mimic physiological control
  • No adverse effect upon maternal and fetal outcome.
  • Should not interfere with antenatal , perinatal and post natal care
  • Insulin Analogues fulfills all the criteria when given in right doses in right manner.
advantages
ADVANTAGES
  • Batch to Batch consistency
  • No allergy, antibody formation
  • No immune mediated lipoatrophy
  • Glucose control is similar in endogenous insulin production
  • Preprandial hypoglycemia and postprandial hyperglycemia are well controlled.
  • Mealtime flexibility is possible with analogues.
safety issues with insulin analogues
Safety issues with Insulin Analogues
  • Ideal insulin
  • Mimic physiological insulin secretion
  • Does not cross placenta
  • No mitogenic potential
  • Since IgG bound insulin can cross placenta, therapeutic agent should not induce antibody generation
hapo hyperglycemia and adverse pregnancy outcome
HAPO: Hyperglycemia And Adverse Pregnancy Outcome

9 countries, 25 centers, 23,325 patients

7 year study

Women were screened between 24-32weeks with fasting glucose, 1 hour and 2 hour post 75 gm glucose .

Medical caregivers were blinded to results except that exceeded pre defined cut offs[ 5.8 fasting, 11.1 post 75 gm glucose] and were then removed from the study.

Birth weight, maternal complications, operative delivery, insulin levels in newborn were studied.

Int J,Gynecology & Obstetrics. 2002,78, (1);69-77

glycemic status in gdm
GLYCEMIC STATUS IN GDM

FASTING HYPOGLYCEMIA

POSTPRANDIAL HYPERGLYCEMIA

Normalisation of this is possible by Insulin Analogues.

insulin aspart qualifies for use in gdm
Insulin aspart qualifies for use in GDM
  • Insulin analogues does not cross the placenta but placental concentration is higher than in maternal blood.
insulin aspart in pregnancy status compared with human insulin
Insulin Aspart in pregnancy status compared with Human Insulin

Moshe Hod et al.,

Studied insulin aspart in Type I diabetic patient

Randomized parallel group open label

Multinational study

  • Decreased hypoglycemic spells
  • Increased fetal outcome
insulin aspart in pregnancy status compared with human insulin39
Insulin Aspart in pregnancy status compared with Human Insulin

Primary objective – Hypoglycemic attacks

Secondary objective – Analyze maternal/fetal outcome

- HbA1c

- 8 point glucose profile

- Number of mild hypoglycemia

- cord blood insulin AB

insulin tactics twice daily split mixed regimens
INSULIN TACTICS Twice-daily Split-mixed Regimens

Regular

NPH

Insulin Effect

B

L

S

HS

B

6-23

continuous subcutaneous insulin infusion csii
Continuous Subcutaneous Insulin Infusion (CSII)
  • Blood glucose levels monitored continuously
  • Pre specified insulin dose is subcutaneously delivered by pump
  • This minimized timing and dosing errors.
continuous glucose monitoring system cgms
Continuous Glucose Monitoring System (CGMS)
  • Blood glucose is assessed periodically
  • Insulin dose is calculated
  • CGMS integrated monitoring system with a delivery device
  • Hence round the clock blood glucose is controlled.
e health system
e-health system
  • Patient has her data in USB device which can be analyzed and seek guidance from internet.
csii cgms
CSII & CGMS
  • Paradigm device connects CGMS and delivery device through bluetooth. This early trial is about to be started in USA.