Trials / Completed
CompletedNCT04902378
Closed-loop Insulin Delivery In Type 1 Diabetes Pregnancies (CIRCUIT)
Closed-loop Insulin Delivery by Glucose Responsive Computer Algorithms In Type 1 Diabetes Pregnancies (CIRCUIT)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 94 (actual)
- Sponsor
- University of Calgary · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Pregnant women with type 1 diabetes (T1D) require normal or near normal glucose in order to reduce the risks of birth defects, stillbirth, increased birthweight, neonatal hypoglycemia, neonatal death, preterm delivery and preeclampsia. Reducing maternal glucose is extremely difficult due to an increased risk of maternal hypoglycemia. Only 14% of T1D pregnancies achieve pregnancy guideline recommended glucose control, leading to complications related to high maternal glucose exposure in roughly half of newborns. Maintaining recommended maternal glucose levels during pregnancy reduces the risk of adverse neonatal outcomes to those similar in pregnancies unaffected by T1D. Most insulin pumps in use today are open-loop systems, which means that the user must program the pump to deliver a pre-set amount of insulin. These insulin delivery methods (MDI and open-loop pumps) are usually inadequate to achieve the optimal glucose control necessary for T1D pregnancies and they impart a large time, effort and emotional burden. Closed-loop systems have been found to be effective in improving glucose control outside of pregnancy when studied in children and adults. A new hybrid closed-loop system, the Tandem t:slim X2 insulin pump with Control IQ technology, recently became commercially available. Trials have demonstrated the efficacy of the Control IQ algorithm for non-pregnant adults and children. Pregnant women were not included in these trials. The investigators propose the first randomized controlled trial to evaluate the Tandem t:slim X2 insulin pump with Control IQ technology versus standard insulin delivery (MDI or pump) and CGM in pregnant women with T1D. In this trial, the investigators 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. We are grateful to Tandem Diabetes Care and Dexcom for in-kind donations to this investigator initiated study.
Conditions
- Type 1 Diabetes Mellitus
- Pregnancy Related
- Glucose Metabolism Disorders
- Metabolic Disease
- Endocrine System Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2021-06-15
- Primary completion
- 2025-05-23
- Completion
- 2025-05-23
- First posted
- 2021-05-26
- Last updated
- 2025-06-05
Locations
14 sites across 2 countries: Australia, Canada
Source: ClinicalTrials.gov record NCT04902378. Inclusion in this directory is not an endorsement.