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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04902378




Registration number
NCT04902378
Ethics application status
Date submitted
28/04/2021
Date registered
26/05/2021

Titles & IDs
Public title
Closed-loop Insulin Delivery In Type 1 Diabetes Pregnancies (CIRCUIT)
Scientific title
Closed-loop Insulin Delivery by Glucose Responsive Computer Algorithms In Type 1 Diabetes Pregnancies (CIRCUIT)
Secondary ID [1] 0 0
REB20-1266
Universal Trial Number (UTN)
Trial acronym
CIRCUIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 0 0
Pregnancy Related 0 0
Glucose Metabolism Disorders 0 0
Metabolic Disease 0 0
Endocrine System Diseases 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Tandem t:slim X2 insulin pump with Control IQ technology

Experimental: Tandem t:slim X2 insulin pump with Control IQ technology plus CGM - Participants randomized to the intervention group will be fitted with the Tandem t:slim X2 insulin pump with Control IQ technology and Dexcom G6 Continuous Glucose Monitor.

No intervention: Standard insulin delivery (multiple daily injections (MDI) or pump) and CGM - Participants randomized to the control group will be fitted with the Dexcom G6 Continuous Glucose Monitor. They will continue to use standard insulin delivery (MDI or pump) and CGM.


Treatment: Devices: Tandem t:slim X2 insulin pump with Control IQ technology
The intervention group will be fitted with the Tandem t:slim X2 insulin pump with Control IQ technology during pregnancy.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glycemic control as reflected by percent glucose time-in-range
Timepoint [1] 0 0
16 weeks until 34 weeks gestation
Secondary outcome [1] 0 0
Percent time spent above target range per day (+/-SD)
Timepoint [1] 0 0
16 weeks gestation until delivery of neonate
Secondary outcome [2] 0 0
Percent time spent below target range per day (+/-SD)
Timepoint [2] 0 0
16 weeks gestation until delivery of neonate
Secondary outcome [3] 0 0
Mean blood glucose measurement at 24 and 34 weeks (+/-SD)
Timepoint [3] 0 0
24 and 34 weeks gestation
Secondary outcome [4] 0 0
Proportion of participants who experience maternal hypoglycemic events
Timepoint [4] 0 0
16 weeks gestation until delivery of neonate
Secondary outcome [5] 0 0
Glycemic variability reflected by the coefficients of variation and standard deviations of CGM data
Timepoint [5] 0 0
16 weeks gestation until delivery of neonate
Secondary outcome [6] 0 0
Diabetes-related distress to the participant
Timepoint [6] 0 0
7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
Secondary outcome [7] 0 0
Fear of hypoglycemia
Timepoint [7] 0 0
7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
Secondary outcome [8] 0 0
Fear of hyperglycemia
Timepoint [8] 0 0
7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
Secondary outcome [9] 0 0
Sleep quality
Timepoint [9] 0 0
7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
Secondary outcome [10] 0 0
Health-related quality of life
Timepoint [10] 0 0
7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
Secondary outcome [11] 0 0
Work productivity
Timepoint [11] 0 0
7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
Secondary outcome [12] 0 0
Diabetes-related distress to the partners
Timepoint [12] 0 0
7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
Secondary outcome [13] 0 0
Proportion of participants who experience preeclampsia events
Timepoint [13] 0 0
16 weeks gestation until delivery of neonate
Secondary outcome [14] 0 0
Proportion of participants who experience gestational hypertension events
Timepoint [14] 0 0
16 weeks gestation until delivery of neonate
Secondary outcome [15] 0 0
Proportion of participants who experience worsening chronic hypertension events
Timepoint [15] 0 0
16 weeks gestation until delivery of neonate
Secondary outcome [16] 0 0
Proportion of participants who have caesarean deliveries
Timepoint [16] 0 0
16 weeks gestation until delivery of neonate
Secondary outcome [17] 0 0
Proportion of participants who experience preterm births
Timepoint [17] 0 0
Delivery of neonate to 6 weeks postpartum
Secondary outcome [18] 0 0
Proportion of babies born large for gestational age (>90th percentile)
Timepoint [18] 0 0
Delivery of neonate
Secondary outcome [19] 0 0
Proportion of babies born small for gestational age (<10th percentile)
Timepoint [19] 0 0
Delivery of neonate
Secondary outcome [20] 0 0
Mean neonatal birthweight (+/-SD)
Timepoint [20] 0 0
Delivery of neonate
Secondary outcome [21] 0 0
Comparison of birthweight z-score
Timepoint [21] 0 0
Delivery of neonate
Secondary outcome [22] 0 0
Proportion of babies born with neonatal hypoglycemia
Timepoint [22] 0 0
Delivery of neonate
Secondary outcome [23] 0 0
Proportion of neonates admitted to intensive care unit admission
Timepoint [23] 0 0
Delivery of neonate to 6 weeks postpartum
Secondary outcome [24] 0 0
Proportion of participants who experienced pregnancy loss or miscarriage (< 20 weeks, stillbirth =20 weeks, neonatal loss up to 28 days)
Timepoint [24] 0 0
7-13 weeks until delivery of neonate + up to 28 days
Secondary outcome [25] 0 0
Proportion of participants who experience episodes of severe hypoglycemia
Timepoint [25] 0 0
7-13 weeks + 6 days gestation until delivery of neonate
Secondary outcome [26] 0 0
Proportion of participants who experience episodes of diabetic ketoacidosis
Timepoint [26] 0 0
7-13 weeks + 6 days gestation until delivery of neonate
Secondary outcome [27] 0 0
Proportion of participants who experience device-related adverse events
Timepoint [27] 0 0
7-13 weeks + 6 days gestation until delivery of neonate

Eligibility
Key inclusion criteria
* Between 18 and 45 years of age (inclusive)
* A diagnosis of type 1 diabetes, as defined by Diabetes Canada, for at least 12 months
* A viable singleton pregnancy confirmed by ultrasound, less than 14 weeks gestation
* Currently on intensive insulin therapy (= 3 injections, or Continuous subcutaneous insulin infusion (CSII)
* Willingness to use the study devices throughout the trial
* A1c = 6.2% and <10% measured any time during pregnancy prior to enrollment
* Able to provide informed consent
* Have access to email
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Non-type 1 diabetes
* Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
* Known or suspected allergy to insulin
* Women with nephropathy (estimated glomerular filtration rate [eGFR] <45), severe autonomic neuropathy, uncontrolled gastroparesis or severe proliferative retinopathy, as judged by the investigator, that is likely to interfere with the normal conduct of the study and interpretation of study results
* Total daily insulin dose <8 or >250 units/day at screening
* Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance
* Unable to communicate effectively in English or French as judged by the investigator
* Current use of Tandem Control IQ, DIY looping system, 670G in Auto Mode, or alternate closed-loop system as judged by the investigator
* Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/03/2025
Actual
Sample size
Target
Accrual to date
Final
94
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Canberra Hospital - Garran
Recruitment hospital [4] 0 0
Royal Women's Hospital - Parkville
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Garran
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment postcode(s) [5] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
Nova Scotia
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
University of Calgary
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lois Donovan, MD
Address 0 0
University of Calgary
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lois Donovan, MD
Address 0 0
Country 0 0
Phone 0 0
1-403-955-8358
Fax 0 0
Email 0 0
lois.donovan@ahs.ca
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04902378