HypoglycemiaNCT02898428
Continuous Glucose Monitoring in New Mothers With Type 1 Diabetes
An observational study of Hypoglycemia and Breastfeeding, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
With appropriate day-time carbohydrate intake and insulin dose, the 24 hour glucose levels and prevalence of night-time hypoglycaemia are comparable in breastfeeding new mothers and formula feeding new mothers with type 1 diabetes at the second after delivery diabetes control compared with the first after delivery… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypoglycemia, Breastfeeding
- What is being tested?
- Continuous glucose monitoring (CGM)
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2016to Apr 2018
- Phase
- Observational
- 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
Study population: New mothers with type 1 diabetes
Who may be able to join
- Age between 18 and 45 years.
- Delivery of a single infant.
- Proficiency in Danish to read and understand the patient information sheet, questionnaires and to converse with the diabetes caregivers.
Who cannot join
- A diagnosis with severe mental or psychiatric barriers or a concurrent disease on the decision of the principal investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Glucose Monitoring During Breastfeeding or Formula Feeding in New Mothers With Type 1 Diabetes
With appropriate day-time carbohydrate intake and insulin dose, the 24 hour glucose levels and prevalence of night-time hypoglycaemia are comparable in breastfeeding new mothers and formula feeding new mothers with type 1 diabetes at the second after delivery diabetes control compared with the first after delivery diabetes control at Steno Diabetes Center.
- Conditions
- Hypoglycemia, Breastfeeding
- Being tested
- Continuous glucose monitoring (CGM)
- Medical subject headings
- Hypoglycemia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoring (CGM)Device
| Study group | Role | What they receive |
|---|---|---|
| New mothers | New mothers with type 1 diabetes Receives: Device: Continuous glucose monitoring (CGM) | |
| Control group | Non-pregnant, non-breastfeeding women with type 1 diabetes matched for age and BMI Receives: Device: Continuous glucose monitoring (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia
Measured: Night-time 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2018
- Study completionApr 2018
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 HypoglycemiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene Ringholm, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898428
- Sponsor's protocol ID
- SDC-2016-055
- Status last verified
- Apr 2018
- First submitted
- 8 Sep 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
Publications
Ringholm L, Roskjaer AB, Engberg S, Andersen HU, Secher AL, Damm P, Mathiesen ER. Breastfeeding at night is rarely followed by hypoglycaemia in women with type 1 diabetes using carbohydrate counting and flexible insulin therapy. Diabetologia. 2019 Mar;62(3):387-398. doi: 10.1007/s00125-018-4794-9. Epub 2019 Jan 3.
PubMed 30607466
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring During Breastfeeding or Formula Feeding in New Mothers With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02898428
- Acronym / sponsor ID
- SDC-2016-055
- Conditions
- Hypoglycemia, Breastfeeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 13 Sep 2016 (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.
With appropriate day-time carbohydrate intake and insulin dose, the 24 hour glucose levels and prevalence of night-time hypoglycaemia are comparable in breastfeeding new mothers and formula feeding new mothers with type 1 diabetes at the second after delivery diabetes control compared with the first after delivery diabetes control at Steno Diabetes Center.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New mothers | – | Device: Continuous glucose monitoring (CGM)New mothers with type 1 diabetes |
| Control group | – | Device: Continuous glucose monitoring (CGM)Non-pregnant, non-breastfeeding women with type 1 diabetes matched for age and BMI |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- New mothers with type 1 diabetes
Key inclusion criteria (3 listed)
- Age between 18 and 45 years.
- Delivery of a single infant.
- Proficiency in Danish to read and understand the patient information sheet, questionnaires and to converse with the diabetes caregivers.
Key exclusion criteria (1 listed)
- A diagnosis with severe mental or psychiatric barriers or a concurrent disease on the decision of the principal investigator
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 |
|---|---|---|
| Continuous glucose monitoring (CGM) | Device | Control group, New mothers |
Primary outcome
Hypoglycemia
Time frame: Night-time 8 hours
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 18 Apr 2018.
- Derived from this study: PubMed 30607466Ringholm L, Roskjaer AB, Engberg S, Andersen HU, Secher AL, Damm P, Mathiesen ER. Breastfeeding at night is rarely followed by hypoglycaemia in women with type 1 diabetes using carbohydrate counting and flexible insulin therapy. Diabetologia. 2019 Mar;62(3):387-398. doi: 10.1007/s00125-018-4794-9. Epub 2019 Jan 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoglycemia and Breastfeeding, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
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 3 inclusion and 1 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 18 Apr 2018. 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 Denmark. 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?
Hypoglycemia (time frame: Night-time 8 hours). 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 NCT02898428, 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 18 Apr 2018.