NCT02898428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

September 8, 2016

Last Update Submit

April 16, 2018

Conditions

HypoglycemiaBreastfeeding

Outcome Measures

Primary Outcomes (1)

  • Hypoglycemia

    Night-time 8 hours

Study Arms (2)

New mothers

New mothers with type 1 diabetes

Device: Continuous glucose monitoring (CGM)

Control group

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

Device: Continuous glucose monitoring (CGM)

Interventions

Continuous glucose monitoring (CGM)DEVICE
Control groupNew mothers

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

New mothers with type 1 diabetes

You may qualify if:

  • 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.

You may not qualify if:

  • A diagnosis with severe mental or psychiatric barriers or a concurrent disease on the decision of the principal investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 30607466DERIVED

MeSH Terms

Conditions

HypoglycemiaBreast Feeding

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 13, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

DK(1)