Clinical trial NCT05037526: Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes
Official title: Diabetes in Pregnancy Project Und Mobile Health in Gestational Diabetes: An Open Label Randomized Controlled Monocentric Trial on the Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 302
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Once a pregnant mother is diagnosed with gestational diabetes mellitus (GDM), she will be treated with either diet, medication (i.e., insulin), or both. The most important factor in GDM management is glycemic control to reduce adverse outcomes. Blood glucose levels have become the "key player" for monitoring and directing treatment during pregnancy. Large trials have confirmed that treatment of GDM to optimize glycemic control can decrease the incidence of many of these associated adverse maternal and neonatal outcomes. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. However, SMBG provides an incomplete picture of the daily glucose profile due to long intervals between finger pricking, and inaccurate self-reported measurements, which heavily rely on patients' compliance.

Detailed description: The incidence of obesity and diabetes is rising worldwide even in younger populations. With a rise in maternal obesity also gestational diabetes mellitus (GDM) becomes more prevalent with a prevalence of up to 18% of pregnancies. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. The main purpose of this study is to prove that real time continuous glucose monitoring (rt-CGM) can effectively reduce the risk for adverse pregnancy and neonatal outcome in GDM. It is further hypothesized that rt-CGM can optimize maternal glycaemic control, increase patients satisfaction and adherence to management strategies of GDM. This is a open label randomized controlled trial with two parallel groups.

Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* GDM diagnosis between 24 0/7- 28 0/7 weeks of pregnancy by a 75g oral glucose test (oGTT)
* Maternal age of 18 to 45 years,
* Singleton gestation
* Gestational age ≥ 24 0/7 weeks and \<32 0/7 weeks at enrollment.

Exclusion Criteria:

* Known hypersensitivity or allergy to the sensor
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders of the participant
* Participation in another study with investigational drug or product within the 30 days preceding and during the present study
* Maternal age \< 18 years,
* Multi-fetal gestations,
* Known fetal structural or chromosomal anomalies
* Chronic use of medications associated with hyperglycemia (steroids)
* Planned preterm delivery
* Overt diabetes mellitus type 1 or 2
* HbA1c by study entry \> 6.5%
* History of bariatric surgery or other surgeries that induce malabsorption
* Fetal growth restriction by study entry

Primary outcomes:
measure: Composite adverse pregnancy and neonatal outcome
timeFrame: 2 years
Secondary outcomes:
measure: Initiated Therapy
timeFrame: 10-14 weeks
measure: Glycemic Outcomes 1
timeFrame: 10-14 weeks
measure: Glycemic Outcomes 2
timeFrame: 10-14 weeks
measure: Glycemic Outcomes 3
timeFrame: 10-14 weeks
measure: Glycemic Outcomes 4
timeFrame: 10-14 weeks
measure: Pregnancy complications
timeFrame: 10-14 weeks
measure: Mode of Delivery
timeFrame: 10-14 weeks
measure: Need for induction of labor
timeFrame: 10-14 weeks
measure: Obstetrical outcome
timeFrame: 10-14 weeks
measure: Maternal outcomes
timeFrame: 10-14 weeks
measure: Maternal weight gain
timeFrame: 10-14 weeks
measure: Maternal Compliance
timeFrame: 10-14 weeks
measure: Maternal satisfaction questionnaire
timeFrame: 10-14 weeks
measure: Postpartum disorder
timeFrame: 10-14 weeks
measure: Birth age
timeFrame: 10-14 weeks
measure: Preterm
timeFrame: 10-14 weeks
measure: Neonatal weight
timeFrame: 10-14 weeks
measure: Neonatal outcome
timeFrame: 10-14 weeks
measure: Neonatal condition
timeFrame: 10-14 weeks
measure: Neonatal Morbidity
timeFrame: 10-14 weeks
measure: Neonatal birth trauma
timeFrame: 10-14 weeks
measure: Resuscitation
timeFrame: 10-14 weeks
measure: Neonatal Care
timeFrame: 10-14 weeks
measure: Respiratory distress syndrome
timeFrame: 10-14 weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital of Bern, Inselspital
Study officials:
affiliation: Uniuversity Hospital and University of Bern
name: Sofia Amylidi-Mohr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castorino K, Polsky S, O'Malley G, Levister C, Nelson K, Farfan C, Brackett S, Puhr S, Levy CJ. Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes Technol Ther. 2020 Dec;22(12):943-947. doi: 10.1089/dia.2020.0085.
citation: Cosson E, Baz B, Gary F, Pharisien I, Nguyen MT, Sandre-Banon D, Jaber Y, Cussac-Pillegand C, Banu I, Carbillon L, Valensi P. Poor Reliability and Poor Adherence to Self-Monitoring of Blood Glucose Are Common in Women With Gestational Diabetes Mellitus and May Be Associated With Poor Pregnancy Outcomes. Diabetes Care. 2017 Sep;40(9):1181-1186. doi: 10.2337/dc17-0369. Epub 2017 Jul 19.
citation: Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15.
citation: Inayama Y, Yamanoi K, Shitanaka S, Ogura J, Ohara T, Sakai M, Suzuki H, Kishimoto I, Tsunenari T, Suginami K. A novel classification of glucose profile in pregnancy based on continuous glucose monitoring data. J Obstet Gynaecol Res. 2021 Apr;47(4):1281-1291. doi: 10.1111/jog.14677. Epub 2021 Jan 27.
citation: Polsky S, Garcetti R, Pyle L, Joshee P, Demmitt JK, Snell-Bergeon JK. Continuous glucose monitor use with and without remote monitoring in pregnant women with type 1 diabetes: A pilot study. PLoS One. 2020 Apr 16;15(4):e0230476. doi: 10.1371/journal.pone.0230476. eCollection 2020.
citation: Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.