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
% 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