ISRCTN56898625已完成未知
Evaluation of the biomedical and psychosocial impact of closed-loop (artificial pancreas) insulin delivery in women with type 1 diabetes during pregnancy
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 124
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35382796/ (added 07/04/2022) 2023 Results article in https://doi.org/10.1056/nejmoa2303911 (added 06/10/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 16/02/2022:
- •1. Between 18 and 45 years of age (inclusive)
- •2. A diagnosis of type 1 diabetes (T1D), as defined by WHO (a chronic condition in which the pancreas produces little or no insulin by itself, characterized by deficient insulin production and a requirement for daily administration of insulin), for at least 12 months
- •3. A viable pregnancy confirmed by ultrasound, up to 13 weeks and 6 days gestation
- •4. Currently on intensive insulin therapy (=3 injections or CSII). This includes women using sensor augmented pumps and/or hybrid closed-loop systems other than CamAPS FX.
- •5. Willingness to use the study devices throughout the trial
- •6. HbA1c level =48 mmol/mol (=6.5%) at booking (first antenatal contact) and =86 mmol/mol (=10%) at point of randomization. A CGM or Libre GMI (glucose management indicator) =48 mmol/mol (=6.5%) or =86 mmol/mol (=10%) may also be used.
- •7. Able to provide informed consent
- •8. Have access to email
- •Previous inclusion criteria:
- •1. Between 18 and 45 years of age (inclusive)
- •2. A diagnosis of type 1 diabetes (T1D), as defined by WHO for at least 12 months
- •3. A viable pregnancy confirmed by ultrasound, at gestational age between 8 weeks and 13 weeks and 6 days
- •4. Currently on intensive insulin therapy (=3 injections or CSII)
- •5. Willingness to use the study devices and complete the CGM assessments
- •6. HbA1c level =48mmol/mol (= 6.5%) at booking (first antenatal contact) and <86 mmol/mol (<10%) at point of randomisation
- •7. Able to provide informed consent
- •8. Have access to email
排除标准
- •Current exclusion criteria as of 16/02/2022:
- •1. Non-type 1 diabetes
- •2. 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
- •3. 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
- •4. Known or suspected allergy against insulin
- •5. 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
- •6. Very good or very poor glycaemic control i.e. first antenatal HbA1c <48mmol/mol (<6.5%) and current HbA1c >86mmol/mol (>10%). A CGM or Libre GMI (glucose management indicator) <48 mmol/mol (<6.5%) or >86 mmol/mol (>10%) may also be used. Women who enter pregnancy with HbA1c or GMI >86 mmol/mol (>10%) may participate if they achieve HbA1c or GMI =86 mmol/mol (=10%) before randomization.
- •7. Total daily insulin dose =1.5 IU/kg at recruitment.
- •8. Severe visual or hearing impairment.
- •9. Unable to speak and understand English.
- •Previous exclusion criteria:
- •1. Non-type 1 diabetes
- •2. 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
- •3. Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids, non-elective beta-blockers and MAO inhibitors
- •4. Known or suspected allergy against insulin
- •5. 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
- •6. Very good or very poor glycaemic control i.e. first antenatal HbA1c < = 48mmol/mol (< = 6.5%) and current HbA1c > 86mmol/mol (10%) . Women who enter pregnancy with HbA1c > 86mmol/mol (10%) may participate if they achieve HbA1c < 86mmol/mol (10%) before randomisation
- •7. Total daily insulin dose more than or equal to 1.5 IU/kg at booking
- •8. Severe visual or hearing impairment
- •9. Unable to speak and understand English
研究者
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