Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
14/08/2024

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
Not applicable
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
This trial will assess the efficacy of the Tandem t:slim X2 insulin pump with Control IQ technology compared with standard insulin delivery plus CGM in pregnant women with type 1 diabetes.
Trial website
https://clinicaltrials.gov/study/NCT04902378
Trial related presentations / publications
Persson M, Norman M, Hanson U. Obstetric and perinatal outcomes in type 1 diabetic pregnancies: A large, population-based study. Diabetes Care. 2009 Nov;32(11):2005-9. doi: 10.2337/dc09-0656. Epub 2009 Aug 12.
Feig DS, Hwee J, Shah BR, Booth GL, Bierman AS, Lipscombe LL. Trends in incidence of diabetes in pregnancy and serious perinatal outcomes: a large, population-based study in Ontario, Canada, 1996-2010. Diabetes Care. 2014 Jun;37(6):1590-6. doi: 10.2337/dc13-2717. Epub 2014 Apr 4.
Evers IM, de Valk HW, Visser GH. Risk of complications of pregnancy in women with type 1 diabetes: nationwide prospective study in the Netherlands. BMJ. 2004 Apr 17;328(7445):915. doi: 10.1136/bmj.38043.583160.EE. Epub 2004 Apr 5.
Murphy HR, Roland JM, Skinner TC, Simmons D, Gurnell E, Morrish NJ, Soo SC, Kelly S, Lim B, Randall J, Thompsett S, Temple RC. Effectiveness of a regional prepregnancy care program in women with type 1 and type 2 diabetes: benefits beyond glycemic control. Diabetes Care. 2010 Dec;33(12):2514-20. doi: 10.2337/dc10-1113.
Maresh MJ, Holmes VA, Patterson CC, Young IS, Pearson DW, Walker JD, McCance DR; Diabetes and Pre-eclampsia Intervention Trial Study Group. Glycemic targets in the second and third trimester of pregnancy for women with type 1 diabetes. Diabetes Care. 2015 Jan;38(1):34-42. doi: 10.2337/dc14-1755. Epub 2014 Nov 3.
Murphy HR, Bell R, Cartwright C, Curnow P, Maresh M, Morgan M, Sylvester C, Young B, Lewis-Barned N. Improved pregnancy outcomes in women with type 1 and type 2 diabetes but substantial clinic-to-clinic variations: a prospective nationwide study. Diabetologia. 2017 Sep;60(9):1668-1677. doi: 10.1007/s00125-017-4314-3. Epub 2017 Jun 8.
Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15. Erratum In: Lancet. 2017 Nov 25;390(10110):2346. doi: 10.1016/S0140-6736(17)32712-5.
Tennant PW, Glinianaia SV, Bilous RW, Rankin J, Bell R. Pre-existing diabetes, maternal glycated haemoglobin, and the risks of fetal and infant death: a population-based study. Diabetologia. 2014 Feb;57(2):285-94. doi: 10.1007/s00125-013-3108-5. Epub 2013 Nov 29.
Singh H, Murphy HR, Hendrieckx C, Ritterband L, Speight J. The challenges and future considerations regarding pregnancy-related outcomes in women with pre-existing diabetes. Curr Diab Rep. 2013 Dec;13(6):869-76. doi: 10.1007/s11892-013-0417-5.
Singh H, Ingersoll K, Gonder-Frederick L, Ritterband L. "Diabetes Just Tends to Take Over Everything": Experiences of Support and Barriers to Diabetes Management for Pregnancy in Women With Type 1 Diabetes. Diabetes Spectr. 2019 May;32(2):118-124. doi: 10.2337/ds18-0035.
Langer N, Langer O. Pre-existing diabetics: relationship between glycemic control and emotional status in pregnancy. J Matern Fetal Med. 1998 Nov-Dec;7(6):257-63. doi: 10.1002/(SICI)1520-6661(199811/12)7:63.0.CO;2-H.
Berg M. Pregnancy and diabetes: how women handle the challenges. J Perinat Educ. 2005 Summer;14(3):23-32. doi: 10.1624/105812405X57552.
Berg M, Honkasalo ML. Pregnancy and diabetes--a hermeneutic phenomenological study of women's experiences. J Psychosom Obstet Gynaecol. 2000 Mar;21(1):39-48. doi: 10.3109/01674820009075607.
Gupton A, Heaman M, Cheung LW. Complicated and uncomplicated pregnancies: women's perception of risk. J Obstet Gynecol Neonatal Nurs. 2001 Mar-Apr;30(2):192-201. doi: 10.1111/j.1552-6909.2001.tb01535.x.
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04902378