Type 1 diabetes pregnancy Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus
Conditions
Interventions
Current intervention as of 16/02/2022:
The trialists are aiming to recruit 124 pregnant women between 18 and 45 years of age with Type 1 Diabetes of at least 12 months’ duration. Participants will be
Sponsors
Norfolk and Norwich University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 86mmol/mol (>10%). A CGM or Libre GMI (glucose management indicator) 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 16/02/2022: Percentage of time spent with glucose levels between 3.5-7.8 mmol/L based on CGM levels between 16 weeks gestation and delivery. Data for the intervention group will be collected as part of the data collection from the AiD closed-loop system. Data for the control group will be collected using software provided by the CGM manufacturer. _____ Previous primary outcome measure: The percentage of time spent with glucose levels between 3.9-7.8 mmol/L based on CGM levels at 24 and 34 weeks gestation. Data for the intervention group will be collected as part of the data collection from the AiD closed-loop system. The control group and those who have withdrawn from the intervention group will have a subcutaneous glucose sensor inserted by the clinical research team and will be instructed to wear it at home for 7-10 days. They will be asked to calibrate the CGM according to manufacturer instructions and to return for CGM sensor downloading within 14 days; Timepoint(s): End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 16/02/2022: The following will be measured using CGM measures: 1. The time spent with CGM glucose levels above and below target range (TAR>7.8mmol/L, TBR70% (16hr 48 min), TAR >7.8mmol/L 24 h 4. Infant feeding at hospital discharge, 8-12 weeks postpartum, and 24 weeks postpartum (breast, bottle, both) 5. Hospital length of stay (from delivery until hospital discharge), including re-admissions >24 h within the first 7 days from birth The following safety measures will be recorded on occurrence during the trial (from hospital records): 1. The frequency and severity of diabetic ketoacidosis during the period of inclusion in the trial 2. The number and severity of episodes of severe hypoglycaemia during the period of inclusion in the trial 3. The number and severity of episodes of adverse device effect Psychosocial outcomes: 1. Questionnaires completed at baseline and 34-36 weeks 2. Qualitative interviews: 25 women randomized to the AiD arm will be interviewed post-randomization and again at 34-36 weeks; up to 25 staff from the trial sites will be interviewed 3. Postpartum: self-reported diabetes and treatment-related experience as described through descriptive writing using free text Health economic outcomes 1. Cost of the closed-loop (study pump, CGM, and CamAPSCamAPS® FX) and control-arm (CGM and insulin delivery) glucose monitoring and insulin delivery systems including device training costs for intervention and control arm participants 2. Maternity health care use including NHS antenatal clinic visits, and between visit contacts which will be grouped as questions around 2.1. Diabetes management 2.2. Technical device issues 2.3.. Both diabetes and device issues 3. Antenatal hospital admissions (number and total length of hospital stay) including the delivery admission length of hospital stay 4. Neonatal health care use including costs of delivery, costs associated with any complications of delivery, and neonatal complica | — |
Countries
England, Northern Ireland, Scotland, United Kingdom
Contacts
Public ContactCorinne Collett
Outcome results
None listed