Continuous Glucose Monitoring in New Mothers With Type 1 Diabetes

NCT ID: NCT02898428

Last Updated: 2018-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypoglycemia Breastfeeding

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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New mothers

New mothers with type 1 diabetes

Continuous glucose monitoring (CGM)

Intervention Type DEVICE

Control group

Non-pregnant, non-breastfeeding women with type 1 diabetes matched for age and BMI

Continuous glucose monitoring (CGM)

Intervention Type DEVICE

Interventions

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Continuous glucose monitoring (CGM)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* A diagnosis with severe mental or psychiatric barriers or a concurrent disease on the decision of the principal investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Steno Diabetes Center Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Lene Ringholm

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Steno Diabetes Center Copenhagen

Gentofte Municipality, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 30607466 (View on PubMed)

Other Identifiers

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SDC-2016-055

Identifier Type: -

Identifier Source: org_study_id

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