None listed
Conditions
Brief summary
Updated criteria for the diagnosis of gestational diabetes (GDM) mean that larger numbers (approximately 18%) of women screened meet diagnostic criteria placing an increasing burden upon limited healthcare professional (HCP) resources. We hypothesise that while the 75g OGTT provides the standard for the diagnosis of GDM, continuous glucose monitoring (CGM) technology could provide a useful adjunct increasing efficiencies in patient care by more effectively triaging patients according to CGM profiles to identify those most likely to require intervention and expediting therapeutic decision-making by the health professional with the provision of more detailed data. All women with GDM diagnosed on OGTT between 24 to 28 weeks gestation will be offered retrospective CGM for a week, in addition to routine fingerprick glucose monitoring. They will also keep a record of HCP visits and time spent for the duration of the pregnancy. GDM management and maternal-fetal outcome data will be collected from medical records. Both OGTT (glucose levels) and CGM profiles (glucose levels and glycaemic variability) will be compared with subsequent therapeutic interventions, healthcare resource utilization and clinical outcomes to determine whether a set of criteria based on the glucose data obtained prior to 31 weeks can be employed to triage patients to either routine or more intensive follow up.
Interventions
Women with gestational diabetes (GDM) diagnosed on 75g- oral glucose tolerance testing (OGTT) performed between 24 to 28 weeks will be offered blinded continuous glucose monitoring (CGM) (iPro) insertion for a week in addition to routine fingerprick testing. They will also record length of time of health care professional visits for the duration of the pregnancy.
The aim of this study is to:
(a) To determine if data provided by a blinded CGM trace of 7 days duration performed during the two w
Women with gestational diabetes (GDM) diagnosed on 75g- oral glucose tolerance testing (OGTT) performed between 24 to 28 weeks will be offered blinded continuous glucose monitoring (CGM) (iPro) insertion for a week in addition to routine fingerprick testing. They will also record length of time of health care professional visits for the duration of the pregnancy. The aim of this study is to: (a) To determine if data provided by a blinded CGM trace of 7 days duration performed during the two week interval following the 24-28 week OGTT in pregnancy can be used for the triage of GDM patients into groups that are either likely or unlikely to require intensification of their clinical care during the remainder of their pregnancy (primary objective). (b) To compare glycaemic profiles provided by the 24-28 week OGTT, fingerprick glucose readings performed in the week post-OGTT and CGM traces as predictors of utilisation of health care resources. (c) To propose a set of CGM parameters as therapeutic targets for patients with GDM. (d) To provide data informing a model of care incorporating CGM technology as part of standard practice.
Sponsors
Mercy Health (Werribee Mercy Hospital)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Pregnant -GDM diagnosed at 24-28 week gestation based on routine 75g-OGTT -Willing to wear CGM -Willing to perform 4 self-monitored blood glucose (SMBG) readings each day
Exclusion criteria
-Pre-existing diabetes (type 1 or type 2 diabetes) -Early GDM diagnosed prior to 24 weeks gestation -Multiple pregnancy -Known major congenital abnormality for current pregnancy -Maternal age <18 years -Allergic reaction to adhesive dressing -Other major maternal medical co-morbidities requiring intensive clinical follow-up -Already on treatment (metformin or insulin) for GDM management
Outcome results
None listed