Pregnant Women With Type 1 DiabetesROKSANANCT04292509
Risk for Ketonaemia in Type 1 Diabetes Pregnancies With Sensor-augmented Pump Therapy
A study testing SAP with stop before low and SAP with stop on low in people with Pregnant Women With Type 1 Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnant Women With Type 1 Diabetes
- What is being tested?
- SAP with stop before low and SAP with stop on low
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Feb 2020to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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%.
Who cannot join
- a physical or psychological disease likely to interfere with the conduct of the study
- medications known to interfere with glucose metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Pregnant Women With Type 1 Diabetes
- Being tested
- SAP with stop before low, SAP with stop on low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAP with stop before lowDevice
cross-over comparison from stop on low to stop before low
SAP with stop on lowDevice
cross-over comparison from stop before low to stop on low
| Study group | Role | What they receive |
|---|---|---|
| SAP with predictive stop before low | Experimental | Sensor-augmented pump therapy with the use of the predictive stop before low mode of action Receives: Device: SAP with stop before low |
| SAP with stop on low | Active comparator | Sensor-augmented pump therapy with the use of the predictive stop on low mode of action Receives: Device: SAP with stop on low |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood ketones > 0.6mmol/l.
ketonaemia
Measured: 4 weeks
Secondary outcomes (16)
mean concentration of blood ketones
Measured: 4 weeks
mean time of suspension of insulin delivery
Measured: 4 weeks
frequency of hospitalization due to ketonaemia
Measured: 4 weeks
mean glucose based on CGM
Measured: 4 weeks
time >140 mg/dl
Measured: 4 weeks
time >180 mg/dl
Measured: 4 weeks
time <63 mg/dl
Measured: 4 weeks
time <50mg/dl
Measured: 4 weeks
coefficient of variation of glycaemic measurements
Measured: 4 weeks
standard deviation of glycaemic measurements
Measured: 4 weeks
mean amplitude of glucose excursions
Measured: 4 weeks
HbA1c
Measured: 4 weeks
time 70-180 mg/dL
Measured: 4 weeks
frequency of CGM use >80% of time
CGM compliance
Measured: 4 weeks
total insulin dose
Measured: 4 weeks
severe hypoglycemic episodes
defined as requiring third-party assistance and/or capillary glucose <50 mg/dL associated with clinical symptoms
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start15 Feb 2020
- Primary completion15 Jun 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant Women With Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- open-label cross-over RCT
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katrien Benhalima, MD PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292509
- Sponsor's protocol ID
- ROKSANA study
- Acronym
- ROKSANA
- Status last verified
- Sep 2021
- First submitted
- 25 Feb 2020
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34647140
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04292509
- Acronym / sponsor ID
- ROKSANA / ROKSANA study
- Conditions
- Pregnant Women With Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label cross-over RCT
| Arm | Type | Receives |
|---|---|---|
| SAP with predictive stop before low | Experimental | Device: SAP with stop before lowSensor-augmented pump therapy with the use of the predictive stop before low mode of action |
| SAP with stop on low | Active comparator | Device: SAP with stop on lowSensor-augmented pump therapy with the use of the predictive stop on low mode of action |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (2 listed)
- a physical or psychological disease likely to interfere with the conduct of the study
- medications known to interfere with glucose metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAP with stop before lowcross-over comparison from stop on low to stop before low | Device | SAP with predictive stop before low |
| SAP with stop on lowcross-over comparison from stop before low to stop on low | Device | SAP with stop on low |
Primary outcome
blood ketones > 0.6mmol/l.
Time frame: 4 weeks
ketonaemia
16 secondary outcomes
mean concentration of blood ketones
Time frame: 4 weeks
mean time of suspension of insulin delivery
Time frame: 4 weeks
frequency of hospitalization due to ketonaemia
Time frame: 4 weeks
mean glucose based on CGM
Time frame: 4 weeks
time >140 mg/dl
Time frame: 4 weeks
time >180 mg/dl
Time frame: 4 weeks
time <63 mg/dl
Time frame: 4 weeks
time <50mg/dl
Time frame: 4 weeks
coefficient of variation of glycaemic measurements
Time frame: 4 weeks
standard deviation of glycaemic measurements
Time frame: 4 weeks
mean amplitude of glucose excursions
Time frame: 4 weeks
HbA1c
Time frame: 4 weeks
time 70-180 mg/dL
Time frame: 4 weeks
frequency of CGM use >80% of time
Time frame: 4 weeks
total insulin dose
Time frame: 4 weeks
severe hypoglycemic episodes
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Derived from this study: PubMed 34647140Benhalima 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrien Benhalima, MD PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAP with stop before low and SAP with stop on low in people with Pregnant Women With Type 1 Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood ketones > 0.6mmol/l. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.