Risk for ketonaemia in type 1 diabetes pregnancies with sensor-augmented pump therapy with predictive low glucose suspend compared to low glucose suspend: an open-label crossover RCT

Falco van Nes; Mathieu Chantal; Laenen Annouschka; Gillard Pieter; Benhalima Katrien

doi:10.1530/endoabs.79.018

Background: Little is known about the influence of the Predictive Low Glucose suspend (PLGS) function of Sensor Augmented Pump therapy on ketone production in patients with type 1 diabetes mellitus (T1DM), compared to the Low Glucose Suspend function. To evaluate the effect, we compared the frequency of elevated ketone levels, the duration of insulin infusion suspension, the glycaemic control and patient satisfaction between the two settings.

Methodology: We carried out an open-label crossover RCT in 10 women with T1DM, aged 18 to 45, using the Medtronic 640G insulin pump. Gestational age at inclusion was 12 to 30 weeks. Patients were randomly assigned between 2 groups. Group 1 used the PLGS function for 2 weeks, followed by LGS for 2 weeks. Group 2 followed the schedule in reverse order. Ketone concentrations were measured 3 times daily (Fasted, 11h-13h, 21h-23h) using the Freestyle Abbott meter. CGM-data were collected to calculate Time in Range (TIR), Time above range (TAR) and Time in hypoglycaemia. Patients also completed 7 questionnaires on treatment satisfaction at baseline and at each study visit.

Results: Median age at inclusion was 31.50 years (24.0-33.0), gestational week was 12.50 weeks (12.0-15.0), TIR was 64.65% (55.6-68.7), BMI was 26.65 kg/m2 (24.5-31.8) and HbA1c was 5.95% (5.8-6.1). 9 patients were Caucasian, 1 had a Northern-African background. 8 women were nulliparous, 1 patient had diabetic retinopathy and 1 had microalbuminuria.


	LGS	PLGS	p-value
Insulin suspension time per day (hours)	2.0 (1.3; 2.3)	3.5 (3.3; 5.0)	0.002
Insulin suspension time over 2 weeks (hours)	28.2 (17.9; 32.0)	48.8 (45.8; 70.0)	0.002
Total ketonaemia (mmol/l)	0.08 (0.06-0.1)	0.08 (0.07; 0.1)	0.084
Fasted ketonaemia (mmol/l)	0.08 (0.05; 0.10)	0.07 (0.06; 0.11)	0.432
Midday ketonaemia (mmol/l)	0.07 (0.04; 0.09)	0.09 (0.08; 0.10)	0.002
Evening ketonaemia (mmol/l)	0.08 (0.06; 0.11)	0.08 (0.06; 0.11)	1.000
Frequency of ketonaemia > 0.6mmol/l (%)	0	0.5 (2)	1.000
Frequency of ketonaemia > 1mmol/l (%)	0	0
TIR (%)	64.7 (58.0; 68.8))	61.1 (56.5; 67.5)	0.492
Time > 140mg/dl	30.1 (23.6; 35.2)	33.3 (28.6; 36.6)	0.193
Time > 180mg/dl	10.4 (6.7; 13.7)	14.4 (10.5; 16.6)	0.275
Time < 63mg/dl	7.5 (4.6; 8.3)	4.2 (2.4; 6.9)	0.014
Time < 50mg/dl	2.1 (1.4; 2.7)	1.1 (0.8; 3.1)	0.232
Low blood glucose index	2.8 (1.8; 3.5)	1.9 (1.4-2.6)	0.019
Coefficient of variation (%)	37.3 (35.3; 39.7)	35.2 (32.9; 39.0)	0.310
Mean amplitude of glycaemic excursions (mg/dl)	121.0 (107.4; 135.6)	123.5 (114.6; 137.6)	1.000
DTSQs	31.0 (26.0; 34.0)	32.0 (27.0; 33.0)	0.656
HFS-B	19.0 (17.0; 22.0)	22.0 (19.0; 23.0)	0.547
PAID-5	2.0 (1.0; 5.0)	3.0 (1.0; 5.0)	1.000

Conclusion: SAP therapy with PLGS mode is a safe alternative to LGS in pregnant T1DM patients, without increased risk for significant ketonaemia. Despite increased suspension time of insulin with PLGS, participants achieved similar glycaemic control, with less time in hypoglycaemia, and similar treatment satisfaction scores.

Endocrine Abstracts

018