DiabetesNCT00994357
The Effect of Real-time Continuous Glucose Monitoring on Severe Complications to Pregnancy in Women With Diabetes
A study testing Real-time CGM in people with Diabetes and Pregnancy, run by University of Copenhagen.
Trial summary
The purpose of the study is to investigate the effects of Real-time Continuous Glucose Monitoring on severe complications to pregnancy in women with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Real-time CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to May 2012
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregestational diabetes, type 1 or type 2
- Single intrauterine pregnancy
- At least 18 years old
- Informed consent
Who cannot join
- Past gestational week 14 at inclusion
- Mental disorders
- Language barriere
- Gemelli
- Diabetic nephropathy
About this study
Official title: The Effect of Real-time Continuous Glucose Monitoring on Severe Complications to Pregnancy in Women With Diabetes: a Randomised Controlled Study
The purpose of the study is to investigate the effects of Real-time Continuous Glucose Monitoring on severe complications to pregnancy in women with diabetes.
Read the detailed description
Pregnancy outcome in women with type 1 or type 2 diabetes is still significantly poorer than in the background population. The prevalence of large fat babies (LGA) is 50% in both types of diabetes, and perinatal death and preterm delivery is 4-7 times higher than in non-diabetic women. These complications are all closely related to non-optimal glycemic control in pregnancy, and improved metabolic control is crucial in our strive for improved pregnancy outcome in these patients.
In 2007, a new generation of "real-time" Continuous Glucose Monitoring (CGM) became available in Denmark. These sensors estimate tissue glucose values automatically and frequently with immediate display of the glucose level. In addition it is possible to set alarms for high and low glucose levels, and the patient can react immediately with changes in diet or insulin dose.
In this trial, 154 patients were randomized to either continuous glucose monitoring at five times in pregnancy in addition to standard care ot to unchanged standard care. The main aim is to evaluate if the use of CGM in pregnancy can reduce the prevalence of LGA from 50 to 30%, but other outcome measurements such as preterm delivery, neonatal disease, hypoglycemia, low grade inflammation and vascular dysfunction, quality of life and self- care are also recorded.
- Being tested
- Real-time CGM, Standard care
- Keywords
- Real-time Continuous Glucose Monitoring, Macrosomia
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time CGMDevice
See previous description.
Standard careOther
See text.
| Study group | Role | What they receive |
|---|---|---|
| Real-time Continuous Glucose Monitoring | Experimental | Real-time Continuous Glucose Monitoring at five times for up to 6 days during pregnancy, and during delivery, in addition to standard monitoring and treatment. Receives: Device: Real-time CGM |
| Control group | Active comparator | Standard monitoring and treatment of diabetic patients during pregnancy. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of LGA in children of diabetic women.
Measured: Obtained shortly after birth
Secondary outcomes (4)
Metabolic control in terms of HbA1c, blood sugar measurements and the occurence of severe hypoglycemia in pregnant diabetic patients.
Measured: During pregnancy
Quality of life, locus of control and anxiety and depression scores in pregnant diabetic patients.
Measured: During pregnancy
Neonatal disease such as neonatal hypoglycemia, respiratory distress and the occurrence of malformations in children of diabetic mothers.
Measured: Shortly after birth
The occurrence of low grade inflammation and endothelial dysfunction in pregnant women with diabetes.
Measured: During pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Lilja Secher, University of Copenhagen
- Investigators
- Elisabeth R Mathiesen, M.D., Study chair, Center for Pregnant Women with Diabetes, Copenhagen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994357
- Sponsor's protocol ID
- SENSOR-01
- Status last verified
- May 2012
- First submitted
- 13 Oct 2009
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Cordua S, Secher AL, Ringholm L, Damm P, Mathiesen ER. Real-time continuous glucose monitoring during labour and delivery in women with Type 1 diabetes - observations from a randomized controlled trial. Diabet Med. 2013 Nov;30(11):1374-81. doi: 10.1111/dme.12246. Epub 2013 Jul 26.
PubMed 23758126Secher AL, Ringholm L, Andersen HU, Damm P, Mathiesen ER. The effect of real-time continuous glucose monitoring in pregnant women with diabetes: a randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1877-83. doi: 10.2337/dc12-2360. Epub 2013 Jan 24.
PubMed 23349548
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Real-time Continuous Glucose Monitoring on Severe Complications to Pregnancy in Women With Diabetes: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT00994357
- Acronym / sponsor ID
- SENSOR-01
- Keywords
- Real-time Continuous Glucose Monitoring, Macrosomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Oct 2009 (estimated)
- 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 purpose of the study is to investigate the effects of Real-time Continuous Glucose Monitoring on severe complications to pregnancy in women with diabetes.
Detailed description
Pregnancy outcome in women with type 1 or type 2 diabetes is still significantly poorer than in the background population. The prevalence of large fat babies (LGA) is 50% in both types of diabetes, and perinatal death and preterm delivery is 4-7 times higher than in non-diabetic women. These complications are all closely related to non-optimal glycemic control in pregnancy, and improved metabolic control is crucial in our strive for improved pregnancy outcome in these patients.
In 2007, a new generation of "real-time" Continuous Glucose Monitoring (CGM) became available in Denmark. These sensors estimate tissue glucose values automatically and frequently with immediate display of the glucose level. In addition it is possible to set alarms for high and low glucose levels, and the patient can react immediately with changes in diet or insulin dose.
In this trial, 154 patients were randomized to either continuous glucose monitoring at five times in pregnancy in addition to standard care ot to unchanged standard care. The main aim is to evaluate if the use of CGM in pregnancy can reduce the prevalence of LGA from 50 to 30%, but other outcome measurements such as preterm delivery, neonatal disease, hypoglycemia, low grade inflammation and vascular dysfunction, quality of life and self- care are also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time Continuous Glucose Monitoring | Experimental | Device: Real-time CGMReal-time Continuous Glucose Monitoring at five times for up to 6 days during pregnancy, and during delivery, in addition to standard monitoring and treatment. |
| Control group | Active comparator | Other: Standard careStandard monitoring and treatment of diabetic patients during pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregestational diabetes, type 1 or type 2
- Single intrauterine pregnancy
- At least 18 years old
- Informed consent
Key exclusion criteria (5 listed)
- Past gestational week 14 at inclusion
- Mental disorders
- Language barriere
- Gemelli
- Diabetic nephropathy
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 |
|---|---|---|
| Real-time CGMSee previous description. | Device | Real-time Continuous Glucose Monitoring |
| Standard careSee text. | Other | Control group |
Primary outcome
Prevalence of LGA in children of diabetic women.
Time frame: Obtained shortly after birth
4 secondary outcomes
Metabolic control in terms of HbA1c, blood sugar measurements and the occurence of severe hypoglycemia in pregnant diabetic patients.
Time frame: During pregnancy
Quality of life, locus of control and anxiety and depression scores in pregnant diabetic patients.
Time frame: During pregnancy
Neonatal disease such as neonatal hypoglycemia, respiratory distress and the occurrence of malformations in children of diabetic mothers.
Time frame: Shortly after birth
The occurrence of low grade inflammation and endothelial dysfunction in pregnant women with diabetes.
Time frame: During pregnancy
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 9 May 2012.
- Derived from this study: PubMed 23758126Cordua S, Secher AL, Ringholm L, Damm P, Mathiesen ER. Real-time continuous glucose monitoring during labour and delivery in women with Type 1 diabetes - observations from a randomized controlled trial. Diabet Med. 2013 Nov;30(11):1374-81. doi: 10.1111/dme.12246. Epub 2013 Jul 26.
- Derived from this study: PubMed 23349548Secher AL, Ringholm L, Andersen HU, Damm P, Mathiesen ER. The effect of real-time continuous glucose monitoring in pregnant women with diabetes: a randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1877-83. doi: 10.2337/dc12-2360. Epub 2013 Jan 24.
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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.
Elisabeth R Mathiesen, M.D. study chair
Center for Pregnant Women with Diabetes, Copenhagen University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Real-time CGM in people with Diabetes and Pregnancy, run by University of Copenhagen.
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 5 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 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Prevalence of LGA in children of diabetic women. (time frame: Obtained shortly after birth). 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 NCT00994357, which also lists 2 linked publications.
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 9 May 2012.