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

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

Sponsors

Lead Sponsor: Universitaire Ziekenhuizen Leuven

Collaborator: University Hospital, Ghent
Universitair Ziekenhuis Brussel
University Hospital, Antwerp
Imelda Hospital, Bonheiden
AZ Sint-Jan AV
AZ Delta
OLV Aalst-Asse-Ninove
General Hospital Groeninge
AZ Nikolaas

Source 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).

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.

Overall Status Not yet recruiting
Start Date October 2020
Completion Date October 2023
Primary Completion Date June 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
time in range from 14 weeks to 36 weeks
Secondary Outcome
Measure Time Frame
time in range during the night from 14 weeks to 36 weeks
time below low day and night from 14 weeks to 36 weeks
overnight time low from 14 weeks to 36 weeks
time in range during the day from 14 weeks to 36 weeks
time in range early pregnancy from 9 weeks to 12 weeks
time in range during each trimester from 9 weeks to 36 weeks
HbA1c during each trimester from 9 weeks to 36 weeks
mean glucose from 14 weeks to 36 weeks
time above target (140mg/dl) from 14 weeks to 36 weeks
time above target (180mg/dl) from 14 weeks to 36 weeks
time below target (50mg/dl) from 14 weeks to 36 weeks
time below target (54mg/dl) from 14 weeks to 36 weeks
duration of hypoglycemia from 14 weeks to 36 weeks
time in nonpregnant target range from 14 weeks to 36 weeks
CGM compliance from 14 weeks to 36 weeks
insulin dose from 14 weeks to 36 weeks
glycemic variability from 14 weeks to 36 weeks
variation glucose values from 14 weeks to 36 weeks
MAGE from 14 weeks to 36 weeks
nocturnal hypoglycemia from 9 weeks to 36 weeks
severe hypoglycemia from 9 weeks to 36 weeks
rate of diabetic keto-acidosis from 9 weeks to 36 weeks
gestational duration delivery
duration hospitalization delivery delivery
type of labor delivery
type of delivery delivery
rate of preterm delivery delivery
rate of gestational hypertension from 20 weeks to delivery
rate of worsening of chronic hypertension from 9 weeks to delivery
rate of preeclampsia from 20 weeks to delivery
rate of eclampsia from 20 weeks to delivery
rate of HELLP syndrome from 20 weeks to delivery
rate of IUGR from 20 weeks to delivery
rate of fetal malformation up to 24 weeks
rate of miscarriage <20 weeks
rate of termination of pregnancy up to 24 weeks
rate of stillbirth >20 weeks
rate of neonatal death 1 month after delivery
sex of infant delivery
birth weight delivery
rate of shoulder dystocia delivery
rate of birth trauma delivery
rate of respiratory distress delivery
rate of hyperbilirubinaemia delivery
rate of macrosomia delivery
rate with high birth weight delivery
rate of LGA infant (lage for gestational age) delivery
rate of SGA infant (small for gestational age) delivery
number with very large gestational age infants delivery
cord blood ph delivery
rate of neonatal hypoglycemia up to 5 days after delivery
rate of NICU admission up to 30 days after delivery
duration NICU admission up to 30 days after delivery
rate of fetal hyperinsulinemia delivery
skinfolds newborn up to 3 days after delivery
neonatal fat mass up to 3 days after delivery
number with composite neonatal outcome delivery
Enrollment 92
Condition
Intervention

Intervention Type: Device

Intervention Name: 780G

Description: 780G closed-loop insulin delivery system (Medtronic)

Arm Group Label: 780G closed-loop

Intervention Type: Device

Intervention Name: standard of care

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

Arm Group Label: standard of care

Eligibility

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)

- 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

- 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

Gender: Female

Gender Based: Yes

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Katrien Benhalima, MD PhD Principal Investigator UZ Leuven
Overall Contact

Last Name: Katrien Benhalima, MD PhD

Phone: 003216340614

Email: [email protected]

Location
Facility: Contact:
OLV Aalst-Asse | Aalst, Oost-Vlaanderen, 9300, Belgium Frank Nobels, MD PhD
UZA | Antwerpen, 2560, Belgium
Imelda Bonheiden | Bonheiden, 2820, Belgium Da Hae Lee, MD
AZ St Jan Brugge | Brugge, 8000, Belgium
UZ Brussel | Brussel, 1090, Belgium
UZ Gent | Gent, 9000, Belgium Joke Marlier, MD
AZ Groeninge Kortrijk | Kortrijk, 8510, Belgium Gerd Vanhaverbeke, MD
UZ Leuven | Leuven, 3000, Belgium Katrien Benhalima, MD PhD
AZ Roeselare | Roeselare, 8800, Belgium Xavier Aers, MD
AZ Nikolaas | Sint-Niklaas, 9100, Belgium Dominique Ballaux, MD
Location Countries

Belgium

Verification Date

August 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 780G closed-loop

Type: Experimental

Description: 780 closed-loop insulin delivery system

Label: standard of care

Type: Active Comparator

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

Acronym CRISTAL
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: 1/1 randomization to 780G or continue with standard of care

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov