CONTINUOUS GLUCOSE MONITORING AND PREGNANCY

Andrea Tumminia

Department of Clinical and Experimental MedicineUniversity of Catania

Garibaldi-Nesima Hospital

April 20th 2018

Achieve pregnancy outcome in the diabetic woman that approximatesthat of the non-diabetic woman

American Diabetes Association, Standard of Medical Care in Diabetes, 2018

GLYCEMIC GOALS FOR PREGNANT WOMEN WITH DIABETES

28 Sett.38 Sett.

Parretti E., Diabetes Care, 24:1319-23, 2001

GLYCEMIC PROFILES DURING PREGNANCY (women without diabetes)

Grafico9

883.44.2

996.44.3

10105.87.1

12124.95.4

13136.33.7

14144.24.5

16164.65.6

18183.84.3

202043.9

21215.53.4

22226.14.1

24244.75.2

223.14.6

443.92.9

664.13.1

883.44.2

26 sett.

38 sett.

Ore

mg/dl

56.2

60.8

90.8

103.9

76.9

90.7

65.4

65.8

91.5

106.5

83.8

97.5

71.8

68.5

62.5

67.4

61.1

66.3

90.7

105.7

78.4

98.5

62.9

67.4

60.8

63.8

60.1

64.7

57.6

61

56.2

60.8

Foglio1

BASELINE (SETT. 12.2 2.4)

ORA8910121314161820212224246824H

CSII

MEDIA102.6116.7114.788.5131.2137.495.8115.593.4128.3125.9110.798.4100.2104.5102.6110.92

DS38.640.740.542.334.540.847.237.344.142.839.345.843.944.542.738.641.475

MDI

MEDIA100.2118.7111.7104.3123.5128.599.7105.8103.2119.9121.4100.2100.397.898.5100.2108.9133333333

DS24.221.528.424.325.722.324.624.127.421.826.222.828.429.727.524.225.26

pNSNSNS

GLUCOSE MONITORING DURING PREGNANCY

- Self Monitoring of Blood Glucose (SMBG)

- Retrospective (Blinded) Continuous Glucose Monitoring

- RT-CGM, Sensor Augmented Insulin Pump (SAP) Therapy

- The Smart Pumps (LGS, PLGS)

- Flash Glucose Monitoring (FGM)

Different study designs Different populations Different primary outcomes Evolving technology2008 2013 2018

RETROSPECTIVE (BLINDED)CONTINUOUS GLUCOSE MONITORING

Murphy et al, BMJ 2008

MACROSOMIA: 35% (intervention arm) P=0.0560% (control arm)

2008 2013 2018

Secher AL et al, Diabetes Care 2013

REAL-TIME (INTERMITTENT)CONTINUOUS GLUCOSE MONITORING

COMPARABLE GLUCOSE CONTROL

COMPARABLE OUTCOMES

INTERVENTION:6 DAYS RT-CGM

(8, 12, 21, 27, 33)

2008 2013 2018

2008 2013 2018

FOUR YEARS LATER

Cochrane Database Syst Rev. 2017 Jun 11;6

> 60-70%

New England Journal of Medicine, 2010

Many studies during pregnancy, even with RT-CGM, have an average sensor use < 15 - 20% of the total time

1

Primary Objective: determine if RT-CGM can improve glycemic control inwomen with T1D who are pregnant or planning pregnancy

Results: 325 women (215 pregnant 110 planning) Real-Time + SMBG vs. SMBG Lower HbA1c in pregnant women using CGM (mean difference

0.19%; p=0.02) CGM users spent more time in target (68% vs 61%; P=0.003) and less

time hyperglycaemic (27% vs 32%; P=0.0279) Perinatal outcomes: lower incidence of: large for gestational age,

neonatal intensive care admissions lasting more than 24h, neonatalhypoglycaemia. Shorter length of hospital stay

1

Lancet. 2017, published online September 15, 2017

(>6 days per week)

1

2008 2013 2018

In diabetic pregnancy, intermittent retrospective CGM use did notreduce the risk of macrosomia. CGM use provides detailedinformation about glycaemic fluctuations but as a treatmentstrategy does not translate into improved pregnancy outcome

The incidence of macrosomia was 31.0% in the CGM group and28.4% in the standard treatment group (RR 1.06, 95%CI 0.83- 1.37).HbA1c levels were similar between treatment groups

2

2008 2013 2018

The detailed information provided by CGM is improving ourunderstanding of various aspects of glucose control and insome cases deepening our understanding of the complexrelationship between glucose and pregnancy outcomes

WOMEN WITH TYPE 1DIABETES SHOWED AHIGHER GLYCEMICVARIABILITY

2-FOLD HIGHER RISK OFHYPERGLYCEMIC SPIKES

HbA1c VALUES DID NOTCORRELATE WITHGLYCEMIC VARIABILITYINDICATORS IN TYPE 1DIABETES PREGNANCIES

2

LOW GLUCOSE SUSPEND (LGS)

PREDICTIVE LOW GLUCOSE SUSPEND (PLGS)

GETTING CLOSER TO THE CLOSED LOOP: THE SMART PUMPS

3

BASAL INTERRUPTION

HYPOGLYCEMIA

HOW DOES IT WORK LGS3

PLGSHOW DOES IT WORK

THE RISK OF DEVELOPMENT OF KETOSIS AND DKA USING THESE SYSTEMS TO SUSPEND INSULIN DELIVERY

IS NOT INCREASED

3

GLUCOSE MONITORING DURING PREGNANCY

- Self Monitoring of Blood Glucose (SMBG)

- Retrospective (Blinded) Continuous Glucose Monitoring

- RT-CGM, Sensor Augmented Insulin Pump (SAP) Therapy

- The Smart Pumps (LGS, PLGS)

- Flash Glucose Monitoring (FGM)

4

T1DM on MDI

17 G.W.

BB AB BL AL BD AD

16/02/2017 112 48 67 59 79 118

17/02/2017 87 132 65 134

18/02/2017 64 70 49 132 89 98

19/02/2017 70 54 80 76 133

20/02/2017 88 111 43 140

21/02/2017 81 146 68 109

22/02/2017 51 137 115 71 122

PLANNED PREGNANCY (HbA1c 6.4%) SECOND PREGNANCY

BREASTFEEDING OF THE FIRST BABY

Self Monitoring of Blood Glucose

4

BREASTFEEDING

T1DM on MDI

18 G.W.

7:30

10:00 13:00

THREE WEEKS LATER

BREASTFEEDING

7:30

10:00 13:00

MEALS

T1DM on MDI

21 G.W.

FGM DURING PREGNANCY2008 2013 2018

Evidences on FGM Efficacy during pregnancy?

women withpre-gest. DM

(N=90)

PREGNANCY POST-PARTUM

RAN

DOM

IZAT

ION

PREGNANCY POST-PARTUM

45 women

45 women

4-8 wks 24-27 wks 36-39 wks 4 wks post

4-8 wks 24-27 wks 36-39 wks 4 wks post

Gluc variab

Risk hypoRisk hyper

Time in range

HbA1c

Gluc variab

Risk hypoRisk hyper

Time in range

HbA1c

Gluc variab

Risk hypoRisk hyper

Time in range

HbA1c

Pregnancy outcomes

Efficacy of Flash Glucose Monitoring in pregnant women with poorly controlled diabetes: a randomized controlled trial

(GRUPPO DI STUDIO SID-AMD DIABETE E GRAVIDANZA)

HbA1c HbA1c HbA1c HbA1c HbA1c

HbA1c HbA1c HbA1c HbA1c HbA1c

+

INTERVENTIONFLASH + 2 SMBG

per day

CONTROL6 SMBG per day

7-9 months 1 month

Gluc variab

Risk hypoRisk hyper

Time in range

HbA1c

andreatumminia@libero.it

% of Time (intermittent vs. continuous)

1

2 3

4

Pathophysiologyinsight

Smart functionsLGS, PLGS

CONTINUOUS EDUCATION

2008 2013 2018

THANKS FOR YOUR ATTENTION

CONTINUOUS Glucose monitoring AND PREGNANCYDiapositiva numero 2GLYCEMIC GOALS FOR PREGNANT WOMEN WITH DIABETESDiapositiva numero 4GLUCOSE MONITORING DURING PREGNANCYRETROSPECTIVE (BLINDED)CONTINUOUS GLUCOSE MONITORINGREAL-TIME (INTERMITTENT)CONTINUOUS GLUCOSE MONITORINGDiapositiva numero 8Diapositiva numero 9Diapositiva numero 10Diapositiva numero 11Diapositiva numero 12Diapositiva numero 13Diapositiva numero 14GETTING CLOSER TO THE CLOSED LOOP: THE SMART PUMPSDiapositiva numero 16Diapositiva numero 17GLUCOSE MONITORING DURING PREGNANCYDiapositiva numero 19Diapositiva numero 20THREE WEEKS LATERDiapositiva numero 22Diapositiva numero 23Diapositiva numero 24Diapositiva numero 25THANKS FOR YOUR ATTENTION