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Type1 DiabetesCRISTALNCT04520971

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

A study testing 780G in people with Type1 Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Type1 Diabetes
What is being tested?
780G
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
12 sitesin 2 countries
Study dates
15 Jan 2021to 10 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Belgium11 sites

  • OLV Aalst-Asse

    Aalst, Oost-Vlaanderen, 9300

  • Imelda Bonheiden

    Bonheiden, 2820

  • AZ St Jan Brugge

    Bruges, 8000

  • UZ Brussel

    Brussels, 1090

  • UCLouvain

    Brussels

  • UZ Gent

    Ghent, 9000

  • AZ Groeninge Kortrijk

    Kortrijk, 8510

  • UZ Leuven

    Leuven, 3000

  • AZ Roeselare

    Roeselare, 8800

  • AZ Nikolaas

    Sint-Niklaas, 9100

  • AZ Turnhout

    Turnhout

Other trials in Belgium

Netherlands1 site

  • Amsterdam UMC

    Amsterdam

Other trials in Netherlands

About this study

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

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).

Read the 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.

Conditions
Type1 Diabetes
Being tested
780G, standard of care
Keywords
closed-loop insulin delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 780GDevice

    780G closed-loop insulin delivery system (Medtronic)

  • standard of careDevice

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

Study groups in NCT04520971
Study groupRoleWhat they receive
780G closed-loopExperimental780 closed-loop insulin delivery system
Receives: Device: 780G
standard of careActive comparatorstandard of care treatment (continue with current treatment of insulin pump without closed-loop or multiple daily insulin injections).
Receives: Device: standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time in range

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

    Measured: from 14 weeks to 36 weeks

Secondary outcomes (57)

  1. time in range during the night

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

    Measured: from 14 weeks to 36 weeks

  2. time below low day and night

    time <63mg/dl day and night

    Measured: from 14 weeks to 36 weeks

  3. overnight time low

    time <63mg/dl from midnight till 6am

    Measured: from 14 weeks to 36 weeks

  4. time in range during the day

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

    Measured: from 14 weeks to 36 weeks

  5. time in range early pregnancy

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

    Measured: from 9 weeks to 12 weeks

  6. time in range during each trimester

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

    Measured: from 9 weeks to 36 weeks

  7. HbA1c during each trimester

    HbA1c (% and mmol/mol) during each trimester

    Measured: from 9 weeks to 36 weeks

  8. mean glucose

    mean glucose based on CGM

    Measured: from 14 weeks to 36 weeks

  9. time above target (140mg/dl)

    time >140mg/dl

    Measured: from 14 weeks to 36 weeks

  10. time above target (180mg/dl)

    time >180mg/dl

    Measured: from 14 weeks to 36 weeks

  11. time below target (50mg/dl)

    time <50mg/dl

    Measured: from 14 weeks to 36 weeks

  12. time below target (54mg/dl)

    time <54mg/dl

    Measured: from 14 weeks to 36 weeks

  13. duration of hypoglycemia

    low blood glucose index

    Measured: from 14 weeks to 36 weeks

  14. time in nonpregnant target range

    time 70-180mg/dl

    Measured: from 14 weeks to 36 weeks

  15. CGM compliance

    % of time use of CGM

    Measured: from 14 weeks to 36 weeks

  16. insulin dose

    total insulin dose

    Measured: from 14 weeks to 36 weeks

  17. glycemic variability

    standard deviation glucose values based on CGM

    Measured: from 14 weeks to 36 weeks

  18. variation glucose values

    coefficient of variation based on CGM

    Measured: from 14 weeks to 36 weeks

  19. MAGE (mean amplitude of glycemic excursions)

    mean amplitude of glucose variations based on CGM

    Measured: from 14 weeks to 36 weeks

  20. nocturnal hypoglycemia

    glucose <50mg/dl from 23-07hour

    Measured: from 9 weeks to 36 weeks

  21. severe hypoglycemia

    hypoglycemia requiring third-part assistance

    Measured: from 9 weeks to 36 weeks

  22. rate of diabetic keto-acidosis

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

    Measured: from 9 weeks to 36 weeks

  23. gestational duration

    duration of pregnancy (weeks)

    Measured: delivery

  24. duration hospitalization delivery

    length of hospital stay (days)

    Measured: delivery

  25. type of labor

    spontaneous, induced or cesarean section before labor

    Measured: delivery

  26. type of delivery

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

    Measured: delivery

  27. rate of preterm delivery

    delivery <37 weeks

    Measured: delivery

  28. rate of gestational hypertension

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

    Measured: from 20 weeks to delivery

  29. rate of worsening of chronic hypertension

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

    Measured: from 9 weeks to delivery

  30. rate of preeclampsia

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

    Measured: from 20 weeks to delivery

  31. rate of eclampsia

    generalized convulsions and/or coma

    Measured: from 20 weeks to delivery

  32. rate of HELLP syndrome

    hemolysis, elevated liver enzymes and a low platelet count

    Measured: from 20 weeks to delivery

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

    intra-uterine growth restriction

    Measured: from 20 weeks to delivery

  34. rate of fetal malformation

    congenital malformation

    Measured: up to 24 weeks

  35. rate of miscarriage

    fetal loss <20 weeks gestations

    Measured: <20 weeks

  36. rate of termination of pregnancy

    induced abortion

    Measured: up to 24 weeks

  37. rate of stillbirth

    mors in utero >20 weeks

    Measured: >20 weeks

  38. rate of neonatal death

    death <1 months after delivery

    Measured: 1 month after delivery

  39. sex of infant

    boy or girl

    Measured: delivery

  40. birth weight

    birth weight (Kg and g)

    Measured: delivery

  41. rate of shoulder dystocia

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

    Measured: delivery

  42. rate of birth trauma

    fracture, damage to nerves...

    Measured: delivery

  43. rate of respiratory distress

    respiratory failure or distress

    Measured: delivery

  44. rate of hyperbilirubinaemia

    hyperbilirubinaemia with need of treatment with phototherapy

    Measured: delivery

  45. rate of macrosomia

    birth weight >4 Kg

    Measured: delivery

  46. rate with high birth weight

    birth weight >4.5 Kg

    Measured: delivery

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

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

    Measured: delivery

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

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

    Measured: delivery

  49. number with very large gestational age infants

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

    Measured: delivery

  50. cord blood ph

    cord blood gas ph

    Measured: delivery

  51. rate of neonatal hypoglycemia

    neonatal hypoglycemia requiring intravenous dextrose

    Measured: up to 5 days after delivery

  52. rate of NICU admission

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

    Measured: up to 30 days after delivery

  53. duration NICU admission

    duration of NICU admission (days or weeks)

    Measured: up to 30 days after delivery

  54. rate of fetal hyperinsulinemia

    cord blood c-peptide

    Measured: delivery

  55. skinfolds newborn

    sum of skinfolds (triceps, scapula and flank)

    Measured: up to 3 days after delivery

  56. neonatal fat mass

    fat mass calculated by the formula of Catalano et al.

    Measured: up to 3 days after delivery

  57. number with composite neonatal outcome

    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

    Measured: delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2020
  2. Study start15 Jan 2021
  3. Primary completion30 Apr 2023
  4. Study completion10 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1/1 randomization to 780G or continue with standard of care
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04520971
Sponsor's protocol ID
S64308
Acronym
CRISTAL
Status last verified
Dec 2024
First submitted
12 Aug 2020
Last updated
10 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Beunen K, Van Wilder N, Ballaux D, Vanhaverbeke G, Taes Y, Aers XP, Nobels F, Marlier J, Lee D, Cuypers J, Preumont V, Siegelaar SE, Painter RC, Laenen A, Gillard P, Mathieu C, Benhalima K. Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial - study protocol. BMC Pregnancy Childbirth. 2023 Mar 16;23(1):180. doi: 10.1186/s12884-023-05481-0.

    PubMed 36927458

  • Benhalima K, Beunen K, Van Wilder N, Ballaux D, Vanhaverbeke G, Taes Y, Aers XP, Nobels F, Marlier J, Lee D, Cuypers J, Preumont V, Siegelaar SE, Painter RC, Laenen A, Gillard P, Mathieu C. Comparing advanced hybrid closed loop therapy and standard insulin therapy in pregnant women with type 1 diabetes (CRISTAL): a parallel-group, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2024 Jun;12(6):390-403. doi: 10.1016/S2213-8587(24)00089-5. Epub 2024 Apr 30.

    PubMed 38697182

Questions about this trial

What is this clinical trial studying?

A study testing 780G in people with Type1 Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time in range (time frame: from 14 weeks to 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04520971, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.

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