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NCT02898428 Clinical Trial

Continuous Glucose Monitoring in New Mothers With Type 1 Diabetes

Breastfeeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02898428
Other study ID # SDC-2016-055
Secondary ID
Status Completed
Phase
First received September 8, 2016
Last updated April 16, 2018
Start date April 2016
Est. completion date April 2018

Study information
Verified date April 2018
Source Steno Diabetes Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 diabetes control at Steno Diabetes Center.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date April 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Continuous glucose monitoring (CGM)

Locations
Country Name City State
Denmark Steno Diabetes Center Copenhagen Gentofte

Sponsors (1)
Lead Sponsor Collaborator
Steno Diabetes Center

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hypoglycemia Night-time 8 hours
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