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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04902378
Registration number
NCT04902378
Ethics application status
Date submitted
28/04/2021
Date registered
26/05/2021
Date last updated
13/02/2024
Titles & IDs
Public title
Closed-loop Insulin Delivery In Type 1 Diabetes Pregnancies (CIRCUIT)
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Scientific title
Closed-loop Insulin Delivery by Glucose Responsive Computer Algorithms In Type 1 Diabetes Pregnancies (CIRCUIT)
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Secondary ID [1]
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REB20-1266
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Universal Trial Number (UTN)
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Trial acronym
CIRCUIT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus
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Pregnancy Related
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Glucose Metabolism Disorders
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Metabolic Disease
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Endocrine System Diseases
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Metabolic and Endocrine
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Metabolic disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Glycemic control as reflected by percent glucose time-in-range
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Assessment method [1]
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Time in range (3.5 to 7.8 mmol/L) per day assessed by CGM glucose measurement
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Timepoint [1]
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16 weeks until 34 weeks gestation
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Secondary outcome [1]
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Percent time spent above target range per day (+/-SD)
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Assessment method [1]
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Glucose above target range defined as glucose >7.8 mmol/L; Blood glucose will be assessed using CGM data
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Timepoint [1]
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16 weeks gestation until delivery of neonate
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Secondary outcome [2]
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Percent time spent below target range per day (+/-SD)
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Assessment method [2]
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Glucose below target range defined as glucose < 3.5 mmol/L; Blood glucose will be assessed using CGM data
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Timepoint [2]
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16 weeks gestation until delivery of neonate
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Secondary outcome [3]
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Mean blood glucose measurement at 24 and 34 weeks (+/-SD)
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Assessment method [3]
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Blood glucose measured in mmol/L and assessed using CGM data
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Timepoint [3]
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24 and 34 weeks gestation
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Secondary outcome [4]
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Proportion of participants who experience maternal hypoglycemic events
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Assessment method [4]
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Maternal hypoglycemic events defined as =15 minutes with CGM glucose <3.5 mmol/L [level 1] or <2.8 mmol/L [level 2]; Blood glucose will be assessed using CGM data
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Timepoint [4]
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16 weeks gestation until delivery of neonate
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Secondary outcome [5]
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Glycemic variability reflected by the coefficients of variation and standard deviations of CGM data
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Assessment method [5]
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Blood glucose measured in mmol/L and assessed using CGM data
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Timepoint [5]
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16 weeks gestation until delivery of neonate
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Secondary outcome [6]
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Diabetes-related distress to the participant
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Assessment method [6]
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Diabetes-related distress will be assessed four times during the study using the Diabetes Distress Screening Scale (DDSS17)
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Timepoint [6]
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7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
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Secondary outcome [7]
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Fear of hypoglycemia
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Assessment method [7]
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Fear of hypoglycemia will be assessed four times during the study using the Hypoglycemia Fear Survey Questionnaire II (HFSQ II)
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Timepoint [7]
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7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
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Secondary outcome [8]
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Fear of hyperglycemia
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Assessment method [8]
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Fear of hyperglycemia will be assessed four times during the study using the g. Hyperglycemia Fear in Pregnancy Survey
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Timepoint [8]
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7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
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Secondary outcome [9]
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Sleep quality
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Assessment method [9]
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Sleep quality will be assessed at four times during the study using the Modified Pittsburgh Sleep Quality Index (PSQI)
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Timepoint [9]
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7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
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Secondary outcome [10]
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Health-related quality of life
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Assessment method [10]
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Health-related quality of life will be assessed four times during the study using the Euro Quality of life questionnaire (EQ-5D-5L)
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Timepoint [10]
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7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
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Secondary outcome [11]
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Work productivity
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Assessment method [11]
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Work productivity will be assessed four times during the study using the Work Productivity and Activity Impairment survey
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Timepoint [11]
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7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
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Secondary outcome [12]
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Diabetes-related distress to the partners
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Assessment method [12]
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Diabetes-related distress to the partners will be assessed four times during the study using the Partner Diabetes Distress Scale
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Timepoint [12]
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7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
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Secondary outcome [13]
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Proportion of participants who experience preeclampsia events
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Assessment method [13]
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Preeclampsia is defined as pregnancy =20 wks gestation with SBP =140mmHg and/or DBP =90 mmHg on =2 occasions a minimum of 6 hrs apart and new-onset of proteinuria (defined as urinary excretion =0.3g protein on a 24-hr urine specimen, or = 2+ by urinary dipstick, or =30mg protein/mmol of urinary creatinine by spot testing) OR =1 of the following adverse conditions:
Eclampsia (Seizures in pregnancy)
Elevated liver function tests (Increased AST and/or ALT >70 IU/L)
Decreased platelet count <100 x 109/L
Elevated serum creatinine (>80 µmol/L)
Small for gestational age infant (birth weight <10th percentile)
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Timepoint [13]
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16 weeks gestation until delivery of neonate
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Secondary outcome [14]
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Proportion of participants who experience gestational hypertension events
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Assessment method [14]
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Gestational hypertension is defined as a woman =20 weeks gestation with a systolic blood pressure of =140 mm Hg and/or a diastolic blood pressure =90 mm Hg on =2 occasions a minimum of 6 hours apart without proteinuria
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Timepoint [14]
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16 weeks gestation until delivery of neonate
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Secondary outcome [15]
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Proportion of participants who experience worsening chronic hypertension events
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Assessment method [15]
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Chronic hypertension is defined as hypertension that is present at <20 weeks gestation or pre-pregnancy
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Timepoint [15]
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16 weeks gestation until delivery of neonate
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Secondary outcome [16]
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Proportion of participants who have caesarean deliveries
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Assessment method [16]
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Timepoint [16]
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16 weeks gestation until delivery of neonate
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Secondary outcome [17]
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Proportion of participants who experience preterm births
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Assessment method [17]
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Preterm birth defined as birth occurring <37 weeks gestation
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Timepoint [17]
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Delivery of neonate to 6 weeks postpartum
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Secondary outcome [18]
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Proportion of babies born large for gestational age (>90th percentile)
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Assessment method [18]
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Timepoint [18]
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Delivery of neonate
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Secondary outcome [19]
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Proportion of babies born small for gestational age (<10th percentile)
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Assessment method [19]
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Timepoint [19]
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Delivery of neonate
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Secondary outcome [20]
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Mean neonatal birthweight (+/-SD)
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Assessment method [20]
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Birthweight measured in kilograms
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Timepoint [20]
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Delivery of neonate
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Secondary outcome [21]
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Comparison of birthweight z-score
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Assessment method [21]
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Timepoint [21]
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Delivery of neonate
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Secondary outcome [22]
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Proportion of babies born with neonatal hypoglycemia
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Assessment method [22]
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Timepoint [22]
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Delivery of neonate
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Secondary outcome [23]
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Proportion of neonates admitted to intensive care unit admission
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Assessment method [23]
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Admission to neonatal intensive care unit admission defined as admission of 24 hours or more
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Timepoint [23]
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Delivery of neonate to 6 weeks postpartum
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Secondary outcome [24]
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Proportion of participants who experienced pregnancy loss or miscarriage (< 20 weeks, stillbirth =20 weeks, neonatal loss up to 28 days)
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Assessment method [24]
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Timepoint [24]
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7-13 weeks until delivery of neonate + up to 28 days
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Secondary outcome [25]
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Proportion of participants who experience episodes of severe hypoglycemia
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Assessment method [25]
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Severe hypoglycemia defined as a hypoglycemic episode requiring assistance from another person.
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Timepoint [25]
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7-13 weeks + 6 days gestation until delivery of neonate
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Secondary outcome [26]
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Proportion of participants who experience episodes of diabetic ketoacidosis
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Assessment method [26]
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Diabetic ketoacidosis (DKA) is defined as an episode with elevated plasma ketones which can be categorized as possible DKA (mild/ self- treated [plasma ketones 0.6 - 1.5mmol/L], moderate/self-treated (plasma ketones > 1.5mmol/L which resolves without hospital admission), or capillary blood ketones >3.0 mol/L without an anion gap of > 15 with admission to hospital for another reason [i.e. prevention of DKA]) or confirmed DKA (severe, with either plasma ketones > 3.0mmol/L or positive serum ketones with an anion gap (Na -(CI+HC03) > 15 and requiring hospital admission for IV fluids and IV insulin to correct the abnormal metabolic state).
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Timepoint [26]
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7-13 weeks + 6 days gestation until delivery of neonate
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Secondary outcome [27]
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Proportion of participants who experience device-related adverse events
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Assessment method [27]
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Device-related adverse events include skin reactions and insulin delivery failures.
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Timepoint [27]
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7-13 weeks + 6 days gestation until delivery of neonate
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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 = 6.5% and <10% measured any time during pregnancy prior to enrollment
- Able to provide informed consent
- Have access to email
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2026
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]
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Canberra Hospital - Garran
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Recruitment hospital [4]
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Royal Women's Hospital - Parkville
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Recruitment hospital [5]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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2560 - Campbelltown
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Recruitment postcode(s) [2]
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- Camperdown
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Recruitment postcode(s) [3]
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- Garran
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Recruitment postcode(s) [4]
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- Parkville
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Recruitment postcode(s) [5]
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- Westmead
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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British Columbia
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Country [3]
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Canada
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State/province [3]
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Manitoba
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Country [4]
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Canada
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State/province [4]
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Ontario
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Country [5]
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Canada
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State/province [5]
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Calgary
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04902378
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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.
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.
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Public notes
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Contacts
Principal investigator
Name
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Lois Donovan, MD
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Address
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University of Calgary
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lois Donovan, MD
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Address
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Country
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Phone
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1-403-955-8358
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04902378
Download to PDF