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Evaluation of steroid effects on glucose and ketone levels in women with diabetes mellitus in pregnancy using novel glucose monitoring devices.

Steroids With Examination and Evaluation of glucose sensing Technology and Ketones in women with diabetes mellitus in Pregnancy (SWEET KIP study)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000980235
Acronym
SWEET KIP
Enrollment
15
Registered
2018-06-12
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to assess the accuracy of continuous interstitial glucose monitoring using two different blood glucose monitoring systems and compare results to conventional methods (finger prick test) in women requiring betamethasone treatment for preterm birth. In usual practice only finger prick testing will occur. In this study the two devices are used on abdomen and upper arm, and an IV cannula is inserted for measurement of blood ketones.

Interventions

Participants will receive 2 doses of IM betamethasone 11.4mg 24 hours apart by the nurse in charge. Each participant will have a Flash glucose monitoring and a continuous glucose monitoring device inserted on the day of admission, prior to IM betamethasone administration. The glucose monitoring devices will be inserted by the study team member. The FGM device will be inserted into the upper outer aspect of the arm, while the CGM device will be inserted on the lower abdomen. This will be in addit

Participants will receive 2 doses of IM betamethasone 11.4mg 24 hours apart by the nurse in charge. Each participant will have a Flash glucose monitoring and a continuous glucose monitoring device inserted on the day of admission, prior to IM betamethasone administration. The glucose monitoring devices will be inserted by the study team member. The FGM device will be inserted into the upper outer aspect of the arm, while the CGM device will be inserted on the lower abdomen. This will be in addition to hourly capillary glucose monitoring which is part of routine care, which commences after betamethasone administration. On day 2 of admission, the participants will have hourly venous blood drawn for glucose and ketones levels. 4 hourly urine ketones will also be collected on this day. IV insulin infusion will be initiated during hospitalisation, as per standard protocol/ medical care, with the rates adjusted according to the hourly capillary blood glucose readings. The IV insulin infusion can be initiated from day 2 of admission or earlier if blood glucose levels are high prior to IM betamethasone administration. Participants will be monitored till day after the second dose of IM betamethasone or until delivery, depending on Obstetrics indication. Hourly blood draws/ urine tests for the study will only be for the 2nd day after steroid use. Participants are encouraged to contInue the use of FGM/ CGM devices while hospitalized and on discharge (or till delivery)- maximum wear of 6 days for CGM and 2 weeks for FGM. The accuracy of interstitial glucose levels as monitored by the flash glucose monitoring and continuous glucose monitoring devices will be compared against venous glucose retrospectively.

Sponsors

Mater Research Funding (Mater Mothers Hospital)
Lead SponsorHospital

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 40 Years
Healthy volunteers
No

Inclusion criteria

Pregnant women requiring IM betamethasone, between 24-36 weeks gestation.

Exclusion criteria

Patient who declined to participate in study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026