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Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes (DiP GlucoMo)

Primary Purpose

Gestational Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Dexcom G System
Self monitoring blood glucose
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Bern, InselspitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dexcom G System

Standard care of gestational diabetes with self monitoring blood glucose (SMBG)

Arm Description

The Dexcom G6 or current version intended use is for the management of diabetes. It is a small flexible device that records interstitial glucose levels every 5 min and is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 or current version System results should be based on the glucose trends and several sequential readings over time. The system consists of a sensor, transmitter, receiver and mobile app.

SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily.

Outcomes

Primary Outcome Measures

Composite adverse pregnancy and neonatal outcome
The primary endpoint is composite adverse pregnancy and neonatal outcome; the proportion of large for gestation age (LGA) newborns (birth weight >90th centile); fetal macrosomia (estimated fetal weight over the 95th centile); incidence of polyhydramnios (maximal vertical pocket ≥ 8 cm); rate of neonatal hypoglycaemia; occurrence of stillbirth. Every each and one of these variables contributes to a better neonatal outcome and are associated. This composite endpoint includes factors influencing decisive the neonatal outcome.

Secondary Outcome Measures

Initiated Therapy
Need for antiglycemic therapy in example Insulin yes/no
Glycemic Outcomes 1
Glycemic variability including number and duration of hypoglycemic and hyperglycemic events, mean interstitial glucose in mmol/L and its standard deviation (SD) A hypoglycemic event was defined for two separate analyses as excursions of at least 15 min below the target range (<3.5 mmol/L), and a hyperglycemic event was defined for two separate analyses as excursions of at least 15 min above the target range (>7.8 mmol/L).
Glycemic Outcomes 2
Time in glucose target in %
Glycemic Outcomes 3
Duration and frequency postprandial hyperglycaemic excursions
Glycemic Outcomes 4
Hemoglobin A1c (HbA1c) values (at inclusion, birth and postpartum) in %
Pregnancy complications
Pregnancy Complications such as Placenta insufficiency (Estimated fetal weight < 10th centile and blood flow changes), Gestational hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mg Hg on two occasions at least 4 hours apart) Preeclampsia (international Society for the Study of Hypertension in Pregnancy (ISSHP) definition)
Mode of Delivery
Mode of delivery including cesarean delivery, induction of labor, need for operative vaginal delivery (forceps or vacuum-assisted vaginal delivery)
Need for induction of labor
Induction of labor yes/no
Obstetrical outcome
Obstetric injury yes/no
Maternal outcomes
Body mass index (BMI) (pre-pregnancy and at the time of delivery) weight and height will be combined to report BMI in kg/m^2
Maternal weight gain
Weight gain after GDM diagnosis in kg
Maternal Compliance
Adherence to therapy yes/no
Maternal satisfaction questionnaire
Patient satisfaction after pregnancy evaluated through a questionnaire
Postpartum disorder
8 weeks postpartum oral glucose test values in mmol/L
Birth age
Gestational age at delivery in weeks
Preterm
Preterm delivery (delivery < 37 weeks gestational age) yes/no
Neonatal weight
Birth weight in grams
Neonatal outcome
Small for gestational age (birth weight < 10%) yes/no
Neonatal condition
Poor condition at birth (Apgar score at 5 minutes <7, Arterial pH of <7.0) yes/no
Neonatal Morbidity
Perinatal morbidity prior to hospital discharge.
Neonatal birth trauma
Birth trauma (brachial plexus injury, or clavicular, humeral, or skull fracture)
Resuscitation
Need for resuscitation yes/no
Neonatal Care
Admission to neonatal intensive care unit (NICU) with length of stay in days
Respiratory distress syndrome
Respiratory distress syndrome (need for supplemental oxygen > 4 hours after birth) yes/no

Full Information

First Posted
July 29, 2021
Last Updated
September 28, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT05037526
Brief Title
Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes
Acronym
DiP GlucoMo
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 24, 2021 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
302 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexcom G System
Arm Type
Active Comparator
Arm Description
The Dexcom G6 or current version intended use is for the management of diabetes. It is a small flexible device that records interstitial glucose levels every 5 min and is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 or current version System results should be based on the glucose trends and several sequential readings over time. The system consists of a sensor, transmitter, receiver and mobile app.
Arm Title
Standard care of gestational diabetes with self monitoring blood glucose (SMBG)
Arm Type
Active Comparator
Arm Description
SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily.
Intervention Type
Device
Intervention Name(s)
Dexcom G System
Intervention Description
Continuous glucose monitoring system
Intervention Type
Device
Intervention Name(s)
Self monitoring blood glucose
Intervention Description
Standard Care
Primary Outcome Measure Information:
Title
Composite adverse pregnancy and neonatal outcome
Description
The primary endpoint is composite adverse pregnancy and neonatal outcome; the proportion of large for gestation age (LGA) newborns (birth weight >90th centile); fetal macrosomia (estimated fetal weight over the 95th centile); incidence of polyhydramnios (maximal vertical pocket ≥ 8 cm); rate of neonatal hypoglycaemia; occurrence of stillbirth. Every each and one of these variables contributes to a better neonatal outcome and are associated. This composite endpoint includes factors influencing decisive the neonatal outcome.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Initiated Therapy
Description
Need for antiglycemic therapy in example Insulin yes/no
Time Frame
10-14 weeks
Title
Glycemic Outcomes 1
Description
Glycemic variability including number and duration of hypoglycemic and hyperglycemic events, mean interstitial glucose in mmol/L and its standard deviation (SD) A hypoglycemic event was defined for two separate analyses as excursions of at least 15 min below the target range (<3.5 mmol/L), and a hyperglycemic event was defined for two separate analyses as excursions of at least 15 min above the target range (>7.8 mmol/L).
Time Frame
10-14 weeks
Title
Glycemic Outcomes 2
Description
Time in glucose target in %
Time Frame
10-14 weeks
Title
Glycemic Outcomes 3
Description
Duration and frequency postprandial hyperglycaemic excursions
Time Frame
10-14 weeks
Title
Glycemic Outcomes 4
Description
Hemoglobin A1c (HbA1c) values (at inclusion, birth and postpartum) in %
Time Frame
10-14 weeks
Title
Pregnancy complications
Description
Pregnancy Complications such as Placenta insufficiency (Estimated fetal weight < 10th centile and blood flow changes), Gestational hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mg Hg on two occasions at least 4 hours apart) Preeclampsia (international Society for the Study of Hypertension in Pregnancy (ISSHP) definition)
Time Frame
10-14 weeks
Title
Mode of Delivery
Description
Mode of delivery including cesarean delivery, induction of labor, need for operative vaginal delivery (forceps or vacuum-assisted vaginal delivery)
Time Frame
10-14 weeks
Title
Need for induction of labor
Description
Induction of labor yes/no
Time Frame
10-14 weeks
Title
Obstetrical outcome
Description
Obstetric injury yes/no
Time Frame
10-14 weeks
Title
Maternal outcomes
Description
Body mass index (BMI) (pre-pregnancy and at the time of delivery) weight and height will be combined to report BMI in kg/m^2
Time Frame
10-14 weeks
Title
Maternal weight gain
Description
Weight gain after GDM diagnosis in kg
Time Frame
10-14 weeks
Title
Maternal Compliance
Description
Adherence to therapy yes/no
Time Frame
10-14 weeks
Title
Maternal satisfaction questionnaire
Description
Patient satisfaction after pregnancy evaluated through a questionnaire
Time Frame
10-14 weeks
Title
Postpartum disorder
Description
8 weeks postpartum oral glucose test values in mmol/L
Time Frame
10-14 weeks
Title
Birth age
Description
Gestational age at delivery in weeks
Time Frame
10-14 weeks
Title
Preterm
Description
Preterm delivery (delivery < 37 weeks gestational age) yes/no
Time Frame
10-14 weeks
Title
Neonatal weight
Description
Birth weight in grams
Time Frame
10-14 weeks
Title
Neonatal outcome
Description
Small for gestational age (birth weight < 10%) yes/no
Time Frame
10-14 weeks
Title
Neonatal condition
Description
Poor condition at birth (Apgar score at 5 minutes <7, Arterial pH of <7.0) yes/no
Time Frame
10-14 weeks
Title
Neonatal Morbidity
Description
Perinatal morbidity prior to hospital discharge.
Time Frame
10-14 weeks
Title
Neonatal birth trauma
Description
Birth trauma (brachial plexus injury, or clavicular, humeral, or skull fracture)
Time Frame
10-14 weeks
Title
Resuscitation
Description
Need for resuscitation yes/no
Time Frame
10-14 weeks
Title
Neonatal Care
Description
Admission to neonatal intensive care unit (NICU) with length of stay in days
Time Frame
10-14 weeks
Title
Respiratory distress syndrome
Description
Respiratory distress syndrome (need for supplemental oxygen > 4 hours after birth) yes/no
Time Frame
10-14 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Amylidi-Mohr, MD
Phone
+41 31 632 1010
Email
sofia.mohr@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Amylidi-Mohr, MD
Organizational Affiliation
Uniuversity Hospital and University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Bern, Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Amylidi-Mohr, MD
Phone
+41 31 632 1010
Email
sofia.mohr@insel.ch
First Name & Middle Initial & Last Name & Degree
Daniel Surbek, Prof
First Name & Middle Initial & Last Name & Degree
Martin Müller, Prof
First Name & Middle Initial & Last Name & Degree
Markus Laimer, Prof

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32324061
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.
Results Reference
result
PubMed Identifier
28724718
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.
Results Reference
result
PubMed Identifier
28923465
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. Erratum In: Lancet. 2017 Nov 25;390(10110):2346.
Results Reference
result
PubMed Identifier
33501738
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.
Results Reference
result
PubMed Identifier
32298269
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.
Results Reference
result
PubMed Identifier
31177185
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.
Results Reference
result

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Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes

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