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

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ClinicalTrials.gov Identifier: NCT04520971
Recruitment Status : Not yet recruiting
First Posted : August 20, 2020
Last Update Posted : December 23, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
Multi-centric open-label randomized controlled trial (RCT) with 10 Belgian centers 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).

Condition or disease Intervention/treatment Phase
Type1 Diabetes Device: 780G Device: standard of care Not Applicable

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) 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1/1 randomization to 780G or continue with standard of care
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes: a Randomized Controlled Trial: the CRISTAL Study
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: 780G closed-loop
780 closed-loop insulin delivery system
Device: 780G
780G closed-loop insulin delivery system (Medtronic)

Active Comparator: standard of care
standard of care treatment (continue with current treatment of insulin pump without closed-loop or multiple daily insulin injections).
Device: standard of care
continue with standard of care treatment (pump without closed-loop or MDI)




Primary Outcome Measures :
  1. time in range [ Time Frame: from 14 weeks to 36 weeks ]
    time between 63-140mg/dl (pregnancy glycemic target range)


Secondary Outcome Measures :
  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 [ 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 140/90mmHg 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 140/90mmHg 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 [ 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 >4Kg

  46. rate with high birth weight [ Time Frame: delivery ]
    birth weight >4.5Kg

  47. rate of LGA infant (lage 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

  57. number with composite neonatal outcome [ Time Frame: delivery ]
    pregnancy loss (miscarriage, still birth or neonatal death), LGA, respiratory distress syndrome, birth trauma, shoulder dystocia, neonatal hypoglycemia and NICU admission



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04520971


Contacts
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Contact: Katrien Benhalima, MD PhD 003216340614 katrien.benhalima@uzleuven.be
Contact: Kaat Beunen, master kaat.beunen@student.kuleuven.be

Locations
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Belgium
OLV Aalst-Asse
Aalst, Oost-Vlaanderen, Belgium, 9300
Contact: Frank Nobels, MD PhD         
UZA
Antwerpen, Belgium, 2560
Imelda Bonheiden
Bonheiden, Belgium, 2820
Contact: Da Hae Lee, MD         
AZ St Jan Brugge
Brugge, Belgium, 8000
UZ Brussel
Brussel, Belgium, 1090
UZ Gent
Gent, Belgium, 9000
Contact: Joke Marlier, MD         
AZ Groeninge Kortrijk
Kortrijk, Belgium, 8510
Contact: Gerd Vanhaverbeke, MD         
UZ Leuven
Leuven, Belgium, 3000
Contact: Katrien Benhalima, MD PhD         
AZ Roeselare
Roeselare, Belgium, 8800
Contact: Xavier Aers, MD         
AZ Nikolaas
Sint-Niklaas, Belgium, 9100
Contact: Dominique Ballaux, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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
Investigators
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Principal Investigator: Katrien Benhalima, MD PhD UZ Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04520971    
Other Study ID Numbers: S64308
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
closed-loop insulin delivery
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases