Trial_T2 Department

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    Enrolling By Invitation
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Updated on 7 September 2022
See if I qualify

Summary

Department

Description


Details
Condition Acne
Age 100years or below
Clinical Study IdentifierTX13182
Last Modified on7 September 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Between 18 and 45 years of age (inclusive)
A diagnosis of type 1 diabetes (T1D), as defined by WHO for at least 12 months
A viable pregnancy confirmed by ultrasound, up to 13 weeks and 6 days gestation
Currently on intensive insulin therapy (≥3 injections or CSII)
Willingness to use the study devices throughout the trial
HbA1c level ≥48 mmol/mol (≥6.5%) at booking (first antenatal contact) and ≤86 mmol/mol (≤10%) at point of randomization
Able to provide informed consent
Have access to email

Exclusion Criteria

Non-type 1 diabetes
Any other physical or psychological disease which, in the opinion of the investigator, is likely to interfere with the normal conduct and interpretation of the study results e.g. untreated coeliac disease or untreated hypothyroidism
Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids, non-selective beta-blockers and MAO inhibitors
Known or suspected allergy against insulin
Women with advanced nephropathy (eGFR <45), severe autonomic neuropathy, uncontrolled gastroparesis or severe proliferative retinopathy, as judged by the investigator, that is likely to interfere with the normal conduct of the study and interpretation of study results
Very good or very poor glycaemic control i.e. first antenatal HbA1c <48 mmol/mol (<6.5%) and current HbA1c >10% (>86 mmol/mol). Women who enter pregnancy with HbA1c >10% (>86 mmol/mol) may participate if they achieve HbA1c ≤10% (≤86 mmol/mol) before randomization
Total daily insulin dose 1.5 IU/kg
Severe visual or hearing impairment
Unable to speak and understand English
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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