Type1 Diabetes
Conditions
Keywords
closed-loop insulin delivery
Brief summary
Multi-centric open-label randomized controlled trial (RCT) with 11 Belgian centers and one Dutch center in pregnant women with type 1 diabetes to assess safety, efficacy, feasibility and cost-effectiveness of 780 MiniMed Medtronic hybrid closed-loop insulin system (intervention group) compared to standard of care therapy (control group).
Detailed description
Women will be recruited with a singleton pregnancy up to 12 weeks gestation. Participants will be randomized 1/1 to 780 pump or standard of care (continue with current treatment of insulin pump without closed-loop or multiple daily insulin injections). Participants will be stratified according to study center, baseline Hba1c, and method of insulin delivery (pump or injections). Participants will be followed-up till delivery. To account for differences in the type of continuous glucose monitoring (CGM) used between the intervention group and the control group, the same CGM system as in the 780 insulin pump group (Guardian™ Sensor 3 and once available the Guardian 4 sensor) will be used in a blinded manner in the control group to collect CGM data during at least four different time points in pregnancy: at 14-17 weeks, 20-23 weeks, 26-29 weeks and 33-36 weeks.
Interventions
DEVICE780G
780G closed-loop insulin delivery system (Medtronic)
DEVICEstandard of care
continue with standard of care treatment (pump without closed-loop or MDI)
Sponsors
University Hospital, Ghent
Universitair Ziekenhuis Brussel
University Hospital, Antwerp
Imelda Hospital, Bonheiden
AZ Sint-Jan AV
AZ Delta
Onze Lieve Vrouw Hospital
General Hospital Groeninge
AZ Nikolaas
AZ Turnhout
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Amsterdam UMC
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1/1 randomization to 780G or continue with standard of care
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women with type 1 diabetes (T1DM), diagnosed with T1DM at least 1 year before pregnancy * Age 18-45 years * A singleton pregnancy confirmed by b-HCG in blood and/or ultrasound-confirmed gestational age up to 11 weeks and 6 days. * Treated with intensive insulin treatment (either MDI or insulin pump). A closed-loop system can only be used in manual mode. * Have a booking HbA1c (measurement taken at the first antenatal clinic visit after confirmed pregnancy) level ≤10%. * Participants need to speak and understand Flemish, French or English and have e-mail access.
Exclusion criteria
* The use of a closed-loop insulin delivery system in auto mode. * A twin (multiple) pregnancy * A physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician) * Medications known to interfere with glucose metabolism * An insulin dose of ≥1.5 units/kg * Known allergy to adhesives due to infusion set and/or CGM
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time in range | from 14 weeks to 36 weeks | time between 63-140mg/dl (pregnancy glycemic target range) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| birth weight | delivery | birth weight (Kg and g) |
| rate of hyperbilirubinaemia | delivery | hyperbilirubinaemia with need of treatment with phototherapy |
| rate of macrosomia | delivery | birth weight \>4 Kg |
| rate with high birth weight | delivery | birth weight \>4.5 Kg |
| rate of shoulder dystocia | delivery | one or both of a baby's shoulders get stuck inside the mother's pelvis during labor. |
| rate of birth trauma | delivery | fracture, damage to nerves... |
| rate of respiratory distress | delivery | respiratory failure or distress |
| rate of eclampsia | from 20 weeks to delivery | generalized convulsions and/or coma |
| rate of HELLP syndrome | from 20 weeks to delivery | hemolysis, elevated liver enzymes and a low platelet count |
| rate of IUGR (intra-uterine growth restriction) | from 20 weeks to delivery | intra-uterine growth restriction |
| rate of fetal malformation | up to 24 weeks | congenital malformation |
| rate of miscarriage | <20 weeks | fetal loss \<20 weeks gestations |
| time in range during the night | from 14 weeks to 36 weeks | time in range (63-140mg/dl) from midnight till 6am |
| time below low day and night | from 14 weeks to 36 weeks | time \<63mg/dl day and night |
| overnight time low | from 14 weeks to 36 weeks | time \<63mg/dl from midnight till 6am |
| time in range during the day | from 14 weeks to 36 weeks | time in range (63-140mg/dl) during the day |
| time in range early pregnancy | from 9 weeks to 12 weeks | time in range (63-140mg/dl) 9-12 weeks |
| time in range during each trimester | from 9 weeks to 36 weeks | time in range (63-140mg/dl) during each trimester |
| HbA1c during each trimester | from 9 weeks to 36 weeks | HbA1c (% and mmol/mol) during each trimester |
| mean glucose | from 14 weeks to 36 weeks | mean glucose based on CGM |
| time above target (140mg/dl) | from 14 weeks to 36 weeks | time \>140mg/dl |
| time above target (180mg/dl) | from 14 weeks to 36 weeks | time \>180mg/dl |
| time below target (50mg/dl) | from 14 weeks to 36 weeks | time \<50mg/dl |
| time below target (54mg/dl) | from 14 weeks to 36 weeks | time \<54mg/dl |
| duration of hypoglycemia | from 14 weeks to 36 weeks | low blood glucose index |
| time in nonpregnant target range | from 14 weeks to 36 weeks | time 70-180mg/dl |
| CGM compliance | from 14 weeks to 36 weeks | % of time use of CGM |
| insulin dose | from 14 weeks to 36 weeks | total insulin dose |
| glycemic variability | from 14 weeks to 36 weeks | standard deviation glucose values based on CGM |
| variation glucose values | from 14 weeks to 36 weeks | coefficient of variation based on CGM |
| MAGE (mean amplitude of glycemic excursions) | from 14 weeks to 36 weeks | mean amplitude of glucose variations based on CGM |
| nocturnal hypoglycemia | from 9 weeks to 36 weeks | glucose \<50mg/dl from 23-07hour |
| severe hypoglycemia | from 9 weeks to 36 weeks | hypoglycemia requiring third-part assistance |
| rate of diabetic keto-acidosis | from 9 weeks to 36 weeks | metabolic keto-acidosis with decreased ph and/or decreased bicarbonate in blood |
| gestational duration | delivery | duration of pregnancy (weeks) |
| duration hospitalization delivery | delivery | length of hospital stay (days) |
| type of labor | delivery | spontaneous, induced or cesarean section before labor |
| rate of termination of pregnancy | up to 24 weeks | induced abortion |
| rate of stillbirth | >20 weeks | mors in utero \>20 weeks |
| rate of neonatal death | 1 month after delivery | death \<1 months after delivery |
| type of delivery | delivery | vaginal, forceps or vacuum, cesarean section during labor or planned cesarean section |
| rate of preterm delivery | delivery | delivery \<37 weeks |
| rate of gestational hypertension | from 20 weeks to delivery | blood pressure of 140/90 mmHg or higher starting after 20 weeks of gestation |
| rate of worsening of chronic hypertension | from 9 weeks to delivery | blood pressure of 140/90 mmHg or higher start is present before 20 weeks of gestation |
| rate of preeclampsia | from 20 weeks to delivery | onset of new hypertension and proteinuria and/or end-organ dysfunction after 20 weeks of gestation |
| rate of LGA infant (large for gestational age) | delivery | gestational age adjusted birth weight \>90th percentile according to the standardized Flemish birth charts adjusted for parity and sex |
| rate of SGA infant (small for gestational age) | delivery | gestational age adjusted birth weight \<10th percentile according to the standardized Flemish birth charts adjusted for parity and sex |
| number with very large gestational age infants | delivery | gestational age adjusted birth weight \>97th percentile according to the standardized Flemish birth charts adjusted for parity and sex |
| cord blood ph | delivery | cord blood gas ph |
| sex of infant | delivery | boy or girl |
| rate of NICU admission | up to 30 days after delivery | Neonatal intensive care unit (NICU) admission defined as requiring a duration of at least 24 h |
| duration NICU admission | up to 30 days after delivery | duration of NICU admission (days or weeks) |
| rate of fetal hyperinsulinemia | delivery | cord blood c-peptide |
| skinfolds newborn | up to 3 days after delivery | sum of skinfolds (triceps, scapula and flank) |
| neonatal fat mass | up to 3 days after delivery | fat mass calculated by the formula of Catalano et al. |
| number with composite neonatal outcome | delivery | pregnancy loss (miscarriage, still birth or neonatal death), LGA (large for gestational age), respiratory distress syndrome, birth trauma, shoulder dystocia, neonatal hypoglycemia and NICU admission |
| rate of neonatal hypoglycemia | up to 5 days after delivery | neonatal hypoglycemia requiring intravenous dextrose |
Countries
Belgium, Netherlands
Outcome results
None listed