Continuous Glucose Tracking in Pregnant Ladies with Type 1 Diabetes (CONCEPTT): a Multicentre International Randomised Controlled Trial

Background: Pregnant ladies with type 1 diabetes are a high-risk population who are suggested to pursue optimum glucose control, however neonatal outcomes credited to maternal hyperglycaemia remain suboptimal. Our goal was to take a look at the effectiveness of constant glucose tracking (CGM) on maternal glucose control and obstetric and neonatal health results. Techniques: In this multicentre, open-label, randomised controlled trial, we recruited ladies aged 18–40 years with type 1 diabetes for a minimum of 12 months who were getting intensive insulin treatment. Participants were pregnant (≤13 weeks and 6 days’ gestation) or preparing pregnancy from 31 health centers in Canada, England, Scotland, Spain, Italy, Ireland, and the U.S.A.. We ran 2 trials in parallel for pregnant individuals and for participants preparing pregnancy. In both trials, individuals were randomly appointed to either CGM in addition to capillary glucose monitoring or capillary glucose monitoring alone. Randomisation was stratified by insulin delivery (pump or injections) and baseline glycated haemoglobin (HbA1c ). The primary result was modification in HbA1c from randomisation to 34 weeks’ gestation in pregnant ladies and to 24 weeks or conception in women preparing pregnancy, and was evaluated in all randomised participants with standard evaluations. Secondary results included obstetric and neonatal health outcomes, evaluated with all offered data without imputation. This trial is registered withClinicalTrials.gov, numberNCT01788527 Findings: In Between March 25, 2013, and March 22, 2016, we randomly designated 325 females (215 pregnant, 110 planning pregnancy) to capillary glucose tracking with CGM (108 pregnant and 53 preparation pregnancy) or without (107 pregnant and 57 preparation pregnancy). We discovered a little difference in HbA1c in pregnant ladies using CGM (mean difference − 0 ·19%;95 %CI − 0 ·34to − 0 ·03; p= 0 ·0207). Pregnant CGM users invested more time in target (68% vs 61%; p= 0 ·0034) and less time hyperglycaemic(27% vs 32%; p= 0 ·0279) than did pregnant control participants, with similar serious hypoglycaemia episodes (18 CGM and21 control) and time spent hypoglycaemic( 3% vs 4%; p= 0 ·10). Neonatal health outcomes were substantially improved, with lower incidence of big for gestational age( chances ratio 0 ·51,95% CI 0 · 28 to 0 ·90; p= 0 ·0210), fewer neonatal intensive care admissions lasting more than24h( 0 ·48; 0 ·26to 0 ·86; p = 0 ·0157), less occurrences of neonatal hypoglycaemia( 0 ·45; 0 ·22 to 0 ·89; p= 0 ·0250), and 1-day much shorter length of medical facility stay ( p= 0 ·0091). We discovered no apparent benefit of CGM in females planning pregnancy. Negative events occurred in51(48%) of CGM individuals and 43(40% )of control participants in the pregnancy trial, and in 12(27%) of CGM participants and21(37 %) of control participants in the planning pregnancy trial. Severe unfavorable occasions occurred in13(6%) participants in the pregnancy trial( 8 [7%] CGM, five [5%] control) and in three( 3%) individuals in the planning pregnancy trial (2[4%] CGM and one [2%] control). The most typical adverse events were skin reactions occurring in49(48 %) of 103CGM individuals and 8( 8%) of104 control participants during pregnancy and in23(44% )of52 CGM individuals and five( 9%) of57control individuals in the planning pregnancy trial. The most common serious adverse events were intestinal( queasiness and vomiting in 4 participants during pregnancy and three individuals preparing pregnancy ). Interpretation: Usage of CGM throughout pregnancy in patients with type 1 diabetes is related to improved neonatal results, which are most likely to be attributed to reduced exposure to maternal hyperglycaemia. CGM should be offered to all pregnant women with type 1 diabetes utilizing extensive insulin treatment. This research study is the first to indicate possible for improvements in non-glycaemic health results from CGM use. Financing: Juvenile Diabetes Research Foundation, Canadian Scientific Trials Network, and National Institute for Health Research.

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