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

December 4, 2024 updated by: Universitaire Ziekenhuizen KU Leuven

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda Bonheiden
      • Brugge, Belgium, 8000
        • AZ St Jan Brugge
      • Brussel, Belgium, 1090
        • UZ Brussel
      • Brussels, Belgium
        • UCLouvain
      • Gent, Belgium, 9000
        • UZ Gent
      • Kortrijk, Belgium, 8510
        • AZ Groeninge Kortrijk
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Roeselare, Belgium, 8800
        • AZ Roeselare
      • Sint-Niklaas, Belgium, 9100
        • AZ Nikolaas
      • Turnhout, Belgium
        • AZ Turnhout
    • Oost-Vlaanderen
      • Aalst, Oost-Vlaanderen, Belgium, 9300
        • OLV Aalst-Asse
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
time in range
Time Frame: from 14 weeks to 36 weeks
time between 63-140mg/dl (pregnancy glycemic target range)
from 14 weeks to 36 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
time in range during the night
Time Frame: from 14 weeks to 36 weeks
time in range (63-140mg/dl) from midnight till 6am
from 14 weeks to 36 weeks
time below low day and night
Time Frame: from 14 weeks to 36 weeks
time <63mg/dl day and night
from 14 weeks to 36 weeks
overnight time low
Time Frame: from 14 weeks to 36 weeks
time <63mg/dl from midnight till 6am
from 14 weeks to 36 weeks
time in range during the day
Time Frame: from 14 weeks to 36 weeks
time in range (63-140mg/dl) during the day
from 14 weeks to 36 weeks
time in range early pregnancy
Time Frame: from 9 weeks to 12 weeks
time in range (63-140mg/dl) 9-12 weeks
from 9 weeks to 12 weeks
time in range during each trimester
Time Frame: from 9 weeks to 36 weeks
time in range (63-140mg/dl) during each trimester
from 9 weeks to 36 weeks
HbA1c during each trimester
Time Frame: from 9 weeks to 36 weeks
HbA1c (% and mmol/mol) during each trimester
from 9 weeks to 36 weeks
mean glucose
Time Frame: from 14 weeks to 36 weeks
mean glucose based on CGM
from 14 weeks to 36 weeks
time above target (140mg/dl)
Time Frame: from 14 weeks to 36 weeks
time >140mg/dl
from 14 weeks to 36 weeks
time above target (180mg/dl)
Time Frame: from 14 weeks to 36 weeks
time >180mg/dl
from 14 weeks to 36 weeks
time below target (50mg/dl)
Time Frame: from 14 weeks to 36 weeks
time <50mg/dl
from 14 weeks to 36 weeks
time below target (54mg/dl)
Time Frame: from 14 weeks to 36 weeks
time <54mg/dl
from 14 weeks to 36 weeks
duration of hypoglycemia
Time Frame: from 14 weeks to 36 weeks
low blood glucose index
from 14 weeks to 36 weeks
time in nonpregnant target range
Time Frame: from 14 weeks to 36 weeks
time 70-180mg/dl
from 14 weeks to 36 weeks
CGM compliance
Time Frame: from 14 weeks to 36 weeks
% of time use of CGM
from 14 weeks to 36 weeks
insulin dose
Time Frame: from 14 weeks to 36 weeks
total insulin dose
from 14 weeks to 36 weeks
glycemic variability
Time Frame: from 14 weeks to 36 weeks
standard deviation glucose values based on CGM
from 14 weeks to 36 weeks
variation glucose values
Time Frame: from 14 weeks to 36 weeks
coefficient of variation based on CGM
from 14 weeks to 36 weeks
nocturnal hypoglycemia
Time Frame: from 9 weeks to 36 weeks
glucose <50mg/dl from 23-07hour
from 9 weeks to 36 weeks
severe hypoglycemia
Time Frame: from 9 weeks to 36 weeks
hypoglycemia requiring third-part assistance
from 9 weeks to 36 weeks
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
from 9 weeks to 36 weeks
gestational duration
Time Frame: delivery
duration of pregnancy (weeks)
delivery
duration hospitalization delivery
Time Frame: delivery
length of hospital stay (days)
delivery
type of labor
Time Frame: delivery
spontaneous, induced or cesarean section before labor
delivery
type of delivery
Time Frame: delivery
vaginal, forceps or vacuum, cesarean section during labor or planned cesarean section
delivery
rate of preterm delivery
Time Frame: delivery
delivery <37 weeks
delivery
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
from 20 weeks to delivery
rate of eclampsia
Time Frame: from 20 weeks to delivery
generalized convulsions and/or coma
from 20 weeks to delivery
rate of HELLP syndrome
Time Frame: from 20 weeks to delivery
hemolysis, elevated liver enzymes and a low platelet count
from 20 weeks to delivery
rate of fetal malformation
Time Frame: up to 24 weeks
congenital malformation
up to 24 weeks
rate of miscarriage
Time Frame: <20 weeks
fetal loss <20 weeks gestations
<20 weeks
rate of termination of pregnancy
Time Frame: up to 24 weeks
induced abortion
up to 24 weeks
rate of stillbirth
Time Frame: >20 weeks
mors in utero >20 weeks
>20 weeks
rate of neonatal death
Time Frame: 1 month after delivery
death <1 months after delivery
1 month after delivery
sex of infant
Time Frame: delivery
boy or girl
delivery
birth weight
Time Frame: delivery
birth weight (Kg and g)
delivery
rate of shoulder dystocia
Time Frame: delivery
one or both of a baby's shoulders get stuck inside the mother's pelvis during labor.
delivery
rate of birth trauma
Time Frame: delivery
fracture, damage to nerves...
delivery
rate of respiratory distress
Time Frame: delivery
respiratory failure or distress
delivery
rate of hyperbilirubinaemia
Time Frame: delivery
hyperbilirubinaemia with need of treatment with phototherapy
delivery
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
delivery
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
delivery
cord blood ph
Time Frame: delivery
cord blood gas ph
delivery
rate of neonatal hypoglycemia
Time Frame: up to 5 days after delivery
neonatal hypoglycemia requiring intravenous dextrose
up to 5 days after delivery
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
up to 30 days after delivery
duration NICU admission
Time Frame: up to 30 days after delivery
duration of NICU admission (days or weeks)
up to 30 days after delivery
rate of fetal hyperinsulinemia
Time Frame: delivery
cord blood c-peptide
delivery
skinfolds newborn
Time Frame: up to 3 days after delivery
sum of skinfolds (triceps, scapula and flank)
up to 3 days after delivery
MAGE (mean amplitude of glycemic excursions)
Time Frame: from 14 weeks to 36 weeks
mean amplitude of glucose variations based on CGM
from 14 weeks to 36 weeks
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
from 20 weeks to delivery
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
from 9 weeks to delivery
rate of IUGR (intra-uterine growth restriction)
Time Frame: from 20 weeks to delivery
intra-uterine growth restriction
from 20 weeks to delivery
rate of macrosomia
Time Frame: delivery
birth weight >4 Kg
delivery
rate with high birth weight
Time Frame: delivery
birth weight >4.5 Kg
delivery
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
delivery
neonatal fat mass
Time Frame: up to 3 days after delivery
fat mass calculated by the formula of Catalano et al.
up to 3 days after delivery
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
delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katrien Benhalima, MD PhD, UZ Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S64308

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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