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Completed

NCT Number: NCT04520971

Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes

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).

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Key information

Conditions

Type1 Diabetes

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OLV Aalst-Asse, Aalst, Oost-Vlaanderen, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

780G

Device

780G closed-loop insulin delivery system (Medtronic)

Standard of care

Device

continue with standard of care treatment (pump without closed-loop or MDI)

Primary outcomes

  1. time in range

    Time frame: from 14 weeks to 36 weeks

    time between 63-140mg/dl (pregnancy glycemic target range)

Secondary outcomes

  1. time in range during the night

    Time frame: from 14 weeks to 36 weeks

    time in range (63-140mg/dl) from midnight till 6am

  2. time below low day and night

    Time frame: from 14 weeks to 36 weeks

    time <63mg/dl day and night

  3. overnight time low

    Time frame: from 14 weeks to 36 weeks

    time <63mg/dl from midnight till 6am

  4. time in range during the day

    Time frame: from 14 weeks to 36 weeks

    time in range (63-140mg/dl) during the day

  5. time in range early pregnancy

    Time frame: from 9 weeks to 12 weeks

    time in range (63-140mg/dl) 9-12 weeks

  6. time in range during each trimester

    Time frame: from 9 weeks to 36 weeks

    time in range (63-140mg/dl) during each trimester

  7. HbA1c during each trimester

    Time frame: from 9 weeks to 36 weeks

    HbA1c (% and mmol/mol) during each trimester

  8. mean glucose

    Time frame: from 14 weeks to 36 weeks

    mean glucose based on CGM

  9. time above target (140mg/dl)

    Time frame: from 14 weeks to 36 weeks

    time >140mg/dl

  10. time above target (180mg/dl)

    Time frame: from 14 weeks to 36 weeks

    time >180mg/dl

  11. time below target (50mg/dl)

    Time frame: from 14 weeks to 36 weeks

    time <50mg/dl

  12. time below target (54mg/dl)

    Time frame: from 14 weeks to 36 weeks

    time <54mg/dl

  13. duration of hypoglycemia

    Time frame: from 14 weeks to 36 weeks

    low blood glucose index

  14. time in nonpregnant target range

    Time frame: from 14 weeks to 36 weeks

    time 70-180mg/dl

  15. CGM compliance

    Time frame: from 14 weeks to 36 weeks

    % of time use of CGM

  16. insulin dose

    Time frame: from 14 weeks to 36 weeks

    total insulin dose

  17. glycemic variability

    Time frame: from 14 weeks to 36 weeks

    standard deviation glucose values based on CGM

  18. variation glucose values

    Time frame: from 14 weeks to 36 weeks

    coefficient of variation based on CGM

  19. MAGE (mean amplitude of glycemic excursions)

    Time frame: from 14 weeks to 36 weeks

    mean amplitude of glucose variations based on CGM

  20. nocturnal hypoglycemia

    Time frame: from 9 weeks to 36 weeks

    glucose <50mg/dl from 23-07hour

  21. severe hypoglycemia

    Time frame: from 9 weeks to 36 weeks

    hypoglycemia requiring third-part assistance

  22. rate of diabetic keto-acidosis

    Time frame: from 9 weeks to 36 weeks

    metabolic keto-acidosis with decreased ph and/or decreased bicarbonate in blood

  23. gestational duration

    Time frame: delivery

    duration of pregnancy (weeks)

  24. duration hospitalization delivery

    Time frame: delivery

    length of hospital stay (days)

  25. type of labor

    Time frame: delivery

    spontaneous, induced or cesarean section before labor

  26. type of delivery

    Time frame: delivery

    vaginal, forceps or vacuum, cesarean section during labor or planned cesarean section

  27. rate of preterm delivery

    Time frame: delivery

    delivery <37 weeks

  28. rate of gestational hypertension

    Time frame: from 20 weeks to delivery

    blood pressure of 140/90 mmHg or higher starting after 20 weeks of gestation

  29. rate of worsening of chronic hypertension

    Time frame: from 9 weeks to delivery

    blood pressure of 140/90 mmHg or higher start is present before 20 weeks of gestation

  30. rate of preeclampsia

    Time frame: from 20 weeks to delivery

    onset of new hypertension and proteinuria and/or end-organ dysfunction after 20 weeks of gestation

  31. rate of eclampsia

    Time frame: from 20 weeks to delivery

    generalized convulsions and/or coma

  32. rate of HELLP syndrome

    Time frame: from 20 weeks to delivery

    hemolysis, elevated liver enzymes and a low platelet count

  33. rate of IUGR (intra-uterine growth restriction)

    Time frame: from 20 weeks to delivery

    intra-uterine growth restriction

  34. rate of fetal malformation

    Time frame: up to 24 weeks

    congenital malformation

  35. rate of miscarriage

    Time frame: <20 weeks

    fetal loss <20 weeks gestations

  36. rate of termination of pregnancy

    Time frame: up to 24 weeks

    induced abortion

  37. rate of stillbirth

    Time frame: >20 weeks

    mors in utero >20 weeks

  38. rate of neonatal death

    Time frame: 1 month after delivery

    death <1 months after delivery

  39. sex of infant

    Time frame: delivery

    boy or girl

  40. birth weight

    Time frame: delivery

    birth weight (Kg and g)

  41. rate of shoulder dystocia

    Time frame: delivery

    one or both of a baby's shoulders get stuck inside the mother's pelvis during labor.

  42. rate of birth trauma

    Time frame: delivery

    fracture, damage to nerves...

  43. rate of respiratory distress

    Time frame: delivery

    respiratory failure or distress

  44. rate of hyperbilirubinaemia

    Time frame: delivery

    hyperbilirubinaemia with need of treatment with phototherapy

  45. rate of macrosomia

    Time frame: delivery

    birth weight >4 Kg

  46. rate with high birth weight

    Time frame: delivery

    birth weight >4.5 Kg

  47. rate of LGA infant (large for gestational age)

    Time frame: delivery

    gestational age adjusted birth weight >90th percentile according to the standardized Flemish birth charts adjusted for parity and sex

  48. rate of SGA infant (small for gestational age)

    Time frame: delivery

    gestational age adjusted birth weight <10th percentile according to the standardized Flemish birth charts adjusted for parity and sex

  49. number with very large gestational age infants

    Time frame: delivery

    gestational age adjusted birth weight >97th percentile according to the standardized Flemish birth charts adjusted for parity and sex

  50. cord blood ph

    Time frame: delivery

    cord blood gas ph

  51. rate of neonatal hypoglycemia

    Time frame: up to 5 days after delivery

    neonatal hypoglycemia requiring intravenous dextrose

  52. rate of NICU admission

    Time frame: up to 30 days after delivery

    Neonatal intensive care unit (NICU) admission defined as requiring a duration of at least 24 h

  53. duration NICU admission

    Time frame: up to 30 days after delivery

    duration of NICU admission (days or weeks)

  54. rate of fetal hyperinsulinemia

    Time frame: delivery

    cord blood c-peptide

  55. skinfolds newborn

    Time frame: up to 3 days after delivery

    sum of skinfolds (triceps, scapula and flank)

  56. neonatal fat mass

    Time frame: up to 3 days after delivery

    fat mass calculated by the formula of Catalano et al.

  57. number with composite neonatal outcome

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • AZ Delta
  • AZ Nikolaas
  • AZ Sint-Jan AV
  • AZ Turnhout
  • Amsterdam UMC
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • General Hospital Groeninge
  • Imelda Hospital, Bonheiden
  • Onze Lieve Vrouw Hospital
  • Universitair Ziekenhuis Brussel
  • University Hospital, Antwerp
  • University Hospital, Ghent

Registry information

Official study title

Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes: a Randomized Controlled Trial: the CRISTAL Study

Acronym: CRISTAL

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 20, 2020
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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