Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes (CRISTAL)
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ClinicalTrials.gov Identifier: NCT04520971 |
Recruitment Status :
Completed
First Posted : August 20, 2020
Last Update Posted : September 15, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type1 Diabetes | Device: 780G Device: standard of care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 95 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 |
Actual Study Start Date : | January 15, 2021 |
Actual Primary Completion Date : | April 30, 2023 |
Actual Study Completion Date : | May 10, 2023 |
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) |
- time in range [ Time Frame: from 14 weeks to 36 weeks ]time between 63-140mg/dl (pregnancy glycemic target range)
- time in range during the night [ Time Frame: from 14 weeks to 36 weeks ]time in range (63-140mg/dl) from midnight till 6am
- time below low day and night [ Time Frame: from 14 weeks to 36 weeks ]time <63mg/dl day and night
- overnight time low [ Time Frame: from 14 weeks to 36 weeks ]time <63mg/dl from midnight till 6am
- time in range during the day [ Time Frame: from 14 weeks to 36 weeks ]time in range (63-140mg/dl) during the day
- time in range early pregnancy [ Time Frame: from 9 weeks to 12 weeks ]time in range (63-140mg/dl) 9-12 weeks
- time in range during each trimester [ Time Frame: from 9 weeks to 36 weeks ]time in range (63-140mg/dl) during each trimester
- HbA1c during each trimester [ Time Frame: from 9 weeks to 36 weeks ]HbA1c (% and mmol/mol) during each trimester
- mean glucose [ Time Frame: from 14 weeks to 36 weeks ]mean glucose based on CGM
- time above target (140mg/dl) [ Time Frame: from 14 weeks to 36 weeks ]time >140mg/dl
- time above target (180mg/dl) [ Time Frame: from 14 weeks to 36 weeks ]time >180mg/dl
- time below target (50mg/dl) [ Time Frame: from 14 weeks to 36 weeks ]time <50mg/dl
- time below target (54mg/dl) [ Time Frame: from 14 weeks to 36 weeks ]time <54mg/dl
- duration of hypoglycemia [ Time Frame: from 14 weeks to 36 weeks ]low blood glucose index
- time in nonpregnant target range [ Time Frame: from 14 weeks to 36 weeks ]time 70-180mg/dl
- CGM compliance [ Time Frame: from 14 weeks to 36 weeks ]% of time use of CGM
- insulin dose [ Time Frame: from 14 weeks to 36 weeks ]total insulin dose
- glycemic variability [ Time Frame: from 14 weeks to 36 weeks ]standard deviation glucose values based on CGM
- variation glucose values [ Time Frame: from 14 weeks to 36 weeks ]coefficient of variation based on CGM
- MAGE [ Time Frame: from 14 weeks to 36 weeks ]mean amplitude of glucose variations based on CGM
- nocturnal hypoglycemia [ Time Frame: from 9 weeks to 36 weeks ]glucose <50mg/dl from 23-07hour
- severe hypoglycemia [ Time Frame: from 9 weeks to 36 weeks ]hypoglycemia requiring third-part assistance
- 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
- gestational duration [ Time Frame: delivery ]duration of pregnancy (weeks)
- duration hospitalization delivery [ Time Frame: delivery ]length of hospital stay (days)
- type of labor [ Time Frame: delivery ]spontaneous, induced or cesarean section before labor
- type of delivery [ Time Frame: delivery ]vaginal, forceps or vacuum, cesarean section during labor or planned cesarean section
- rate of preterm delivery [ Time Frame: delivery ]delivery <37 weeks
- rate of gestational hypertension [ Time Frame: from 20 weeks to delivery ]blood pressure of 140/90mmHg or higher starting after 20 weeks of gestation
- 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
- 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
- rate of eclampsia [ Time Frame: from 20 weeks to delivery ]generalized convulsions and/or coma
- rate of HELLP syndrome [ Time Frame: from 20 weeks to delivery ]hemolysis, elevated liver enzymes and a low platelet count
- rate of IUGR [ Time Frame: from 20 weeks to delivery ]intra-uterine growth restriction
- rate of fetal malformation [ Time Frame: up to 24 weeks ]congenital malformation
- rate of miscarriage [ Time Frame: <20 weeks ]fetal loss <20 weeks gestations
- rate of termination of pregnancy [ Time Frame: up to 24 weeks ]induced abortion
- rate of stillbirth [ Time Frame: >20 weeks ]mors in utero >20 weeks
- rate of neonatal death [ Time Frame: 1 month after delivery ]death <1 months after delivery
- sex of infant [ Time Frame: delivery ]boy or girl
- birth weight [ Time Frame: delivery ]birth weight (Kg and g)
- rate of shoulder dystocia [ Time Frame: delivery ]one or both of a baby's shoulders get stuck inside the mother's pelvis during labor.
- rate of birth trauma [ Time Frame: delivery ]fracture, damage to nerves...
- rate of respiratory distress [ Time Frame: delivery ]respiratory failure or distress
- rate of hyperbilirubinaemia [ Time Frame: delivery ]hyperbilirubinaemia with need of treatment with phototherapy
- rate of macrosomia [ Time Frame: delivery ]birth weight >4Kg
- rate with high birth weight [ Time Frame: delivery ]birth weight >4.5Kg
- 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
- 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
- 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
- cord blood ph [ Time Frame: delivery ]cord blood gas ph
- rate of neonatal hypoglycemia [ Time Frame: up to 5 days after delivery ]neonatal hypoglycemia requiring intravenous dextrose
- 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
- duration NICU admission [ Time Frame: up to 30 days after delivery ]duration of NICU admission (days or weeks)
- rate of fetal hyperinsulinemia [ Time Frame: delivery ]cord blood c-peptide
- skinfolds newborn [ Time Frame: up to 3 days after delivery ]sum of skinfolds (triceps, scapula and flank)
- neonatal fat mass [ Time Frame: up to 3 days after delivery ]fat mass calculated by the formula of Catalano
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts 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
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
Belgium | |
OLV Aalst-Asse | |
Aalst, Oost-Vlaanderen, Belgium, 9300 | |
Imelda Bonheiden | |
Bonheiden, Belgium, 2820 | |
AZ St Jan Brugge | |
Brugge, Belgium, 8000 | |
UCLouvain | |
Brussels, Belgium | |
UZ Brussel | |
Brussel, Belgium, 1090 | |
UZ Gent | |
Gent, Belgium, 9000 | |
AZ Groeninge Kortrijk | |
Kortrijk, Belgium, 8510 | |
UZ Leuven | |
Leuven, Belgium, 3000 | |
AZ Roeselare | |
Roeselare, Belgium, 8800 | |
AZ Nikolaas | |
Sint-Niklaas, Belgium, 9100 | |
AZ Turnhout | |
Turnhout, Belgium | |
Netherlands | |
Amsterdam UMC | |
Amsterdam, Netherlands |
Principal Investigator: | Katrien Benhalima, MD PhD | UZ Leuven |
Responsible Party: | Universitaire Ziekenhuizen KU Leuven |
ClinicalTrials.gov Identifier: | NCT04520971 |
Other Study ID Numbers: |
S64308 |
First Posted: | August 20, 2020 Key Record Dates |
Last Update Posted: | September 15, 2023 |
Last Verified: | September 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
closed-loop insulin delivery |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |