Risk for Ketonaemia in Type 1 Diabetes Pregnancies With Sensor-augmented Pump Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Risk for Ketonaemia in Type 1 Diabetes Pregnancies With Sensor-augmented Pump Therapy With Predictive Stop Before Low Compared to Stop on Low: an Open-label Crossover RCT

Conditions
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Pregnant Women With Type 1 Diabetes

Intervention / Treatment
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* Device: SAP with stop before low
* Device: SAP with stop on low


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 1 diabetes age 18-45 years a singleton pregnancy with ultrasound-confirmed gestational age between 12- 30 weeks. treated with 640 insulin pump and have a baseline HbA1c level ≤10%. Exclusion Criteria: a physical or psychological disease likely to interfere with the conduct of the study medications known to interfere with glucose metabolism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: open-label cross-over RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAP with predictive stop before low<br>Sensor-augmented pump therapy with the use of the predictive stop before low mode of action | Device: SAP with stop before low<br>* cross-over comparison from stop on low to stop before low<br>|
| Active Comparator: SAP with stop on low<br>Sensor-augmented pump therapy with the use of the predictive stop on low mode of action | Device: SAP with stop on low<br>* cross-over comparison from stop before low to stop on low<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood ketones > 0.6mmol/l. | ketonaemia | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |