Study of the impact of insulin pump therapy, augmented with continuous glucose monitoring, on outcomes for mother and baby, in pregnant women with Type 1 diabetes when compared to conventional treatment with insulin pump therapy alone or multiple daily insulin injections.

Not Applicable

Recruiting

• Conditions: TYpe 1 Diabetes Mellitus; Pregnancy; Metabolic and Endocrine - Diabetes; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12617000359336
• Lead Sponsor: Dr Sophie Poulter

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-08
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

1. Women with Type 1 diabetes who are preconception (planning pregnancy but not yet pregnant) or in early pregnancy (less than 12 weeks gestation) who currently administer insulin.

2. Criteria for intervention:
i. Inability to achieve target HbA1c (<6.5%) or having significant hypoglycaemia using conventional treatment with multiple daily injections;
ii. Women who can demonstrate willingness and ability to carbohydrate count and undertake the required education to use insulin pump therapy;
iii. Women who are willing to enter into an agreement/contract outlining: a) that they will be responsible for the insulin pump consumables (cannulae, infusion sets and reservoirs) for the duration of the pump loan (approx. $30/month); b) that there will be a 3 month trial period where they will need to meet criteria (including appropriate education, ability to use the pump, improvement in predefined glycaemic parameters) for ongoing use of a loan pump; c) that the pump will be loaned until up to 4 weeks postdelivery, after which the pump will be returned to the department.

Exclusion Criteria

1. Women not planning pregnancy.

2. Women presenting after 12 weeks gestation.

3. Exclusion from intervention includes women not demonstrating willingness to undertake appropriate education or accept conditions of loan of pump.

Study & Design

• Study Type: Interventional
• Study Design: Not specified