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OpenTrials
Completed

NCT Number: NCT02898428

Continuous Glucose Monitoring 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.

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Key information

Conditions

Hypoglycemia Behavior Breast Feeding Breastfeeding Feeding Behavior Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous glucose monitoring (CGM)

Device

Primary outcomes

  1. Hypoglycemia

    Time frame: Night-time 8 hours

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Official study title

Continuous Glucose Monitoring During Breastfeeding or Formula Feeding in New Mothers With Type 1 Diabetes

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2016
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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