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The ROKSANA study is an open-label crossover RCT with the aim to evaluate whether sensor-augmented pump therapy (SAP) with predictive low glucose suspend technology is associated with an increased risk for ketonaemia during type 1 diabetes pregnancies.
10 pregnant women with type 1 diabetes will be included . Participants will be randomized 1/1 between 12-30 weeks of pregnancy to SAP with predictive stop before low during two weeks or predictive stop on low. Participants will be cross-over to the other group after two weeks (from stop before low to stop on low or vice versa). During the study, participants will be asked to measure blood ketones three times per day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAP with predictive stop before low | Experimental | Sensor-augmented pump therapy with the use of the predictive stop before low mode of action |
|
| SAP with stop on low | Active Comparator | Sensor-augmented pump therapy with the use of the predictive stop on low mode of action |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAP with stop before low | Device | cross-over comparison from stop on low to stop before low |
|
| Measure | Description | Time Frame |
|---|---|---|
| blood ketones > 0.6mmol/l. | ketonaemia | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| mean concentration of blood ketones | 4 weeks | |
| mean time of suspension of insulin delivery | 4 weeks | |
| frequency of hospitalization due to ketonaemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrien Benhalima, MD PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34647140 | Derived | Benhalima K, van Nes F, Laenen A, Gillard P, Mathieu C. Risk for ketonaemia in type 1 diabetes pregnancies with sensor-augmented pump therapy with predictive low glucose suspend compared with low glucose suspend: a crossover RCT. Diabetologia. 2021 Dec;64(12):2725-2730. doi: 10.1007/s00125-021-05589-y. Epub 2021 Oct 13. |
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open-label cross-over RCT
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| SAP with stop on low | Device | cross-over comparison from stop before low to stop on low |
|
| 4 weeks |
| mean glucose based on CGM | 4 weeks |
| time >140 mg/dl | 4 weeks |
| time >180 mg/dl | 4 weeks |
| time <63 mg/dl | 4 weeks |
| time <50mg/dl | 4 weeks |
| coefficient of variation of glycaemic measurements | 4 weeks |
| standard deviation of glycaemic measurements | 4 weeks |
| mean amplitude of glucose excursions | 4 weeks |
| HbA1c | 4 weeks |
| time 70-180 mg/dL | 4 weeks |
| frequency of CGM use >80% of time | CGM compliance | 4 weeks |
| total insulin dose | 4 weeks |
| severe hypoglycemic episodes | defined as requiring third-party assistance and/or capillary glucose <50 mg/dL associated with clinical symptoms | 4 weeks |