Continuous Glucose Monitoring in New Mothers With Type 1 Diabetes

Completed

• Conditions: Breastfeeding; Hypoglycemia
• Interventions: Device: Continuous glucose monitoring (CGM)

• Registration Number: NCT02898428
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-13
• Primary Completion: 2018-03
• Status Verified: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
New mothers	Continuous glucose monitoring (CGM)	New mothers with type 1 diabetes
Control group	Continuous glucose monitoring (CGM)	Non-pregnant, non-breastfeeding women with type 1 diabetes matched for age and BMI

Primary Outcome Measures

Name	Time	Method
Hypoglycemia	Night-time 8 hours

Trial Locations

Locations (1)

Steno Diabetes Center Copenhagen; 🇩🇰 Gentofte, Denmark