Glycemic Objectives of Women With Gestational Diabetes Mellitus

Université de Sherbrooke

Status and phase: Terminated; Phase 3

Conditions: Gestational Diabetes Mellitus

Treatments: Procedure: Low glycemic control; Procedure: Normal glycemic control

Study type: Interventional

Funder types: Other

Identifiers

NCT02478762

14-160

Details and patient eligibility

About

In a previous study, the investigators established the dosage of foetal glycated hemoglobin (FGH). It represents the mean of blood sugar 4-6 before the delivery. The investigators also compared the FGH of newborn of women with and without gestational diabetes mellitus (GDM) and determined that newborn of women with GDM had significantly higher FGH that newborn of women without GDM.

In this study, the investigators want to compare the FGH of newborn of GDM women randomized to a group reaching the Canadian Diabetes Association recommended blood glucose objectives treatment (fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L) to a group reaching lower blood glucose objectives (fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L)

Enrollment: 5 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• gestational age between 15 and 32 weeks since last menstrual date,
• received education on gestational diabetes mellitus,
• able to read and understand French.

Exclusion criteria

• known type 1 or type 2 diabetes,
• treatment interfering woth glucose metabolism,
• deficit may hinder the understanding of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Normal glycemic control

Active Comparator group

Description:

GDM women in this group will reach glycemic objectives recommended by the Canadian Diabetes Association: fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L.

Treatment:

Procedure: Normal glycemic control

Low glycemic control

Experimental group

Description:

GDM women in this group will reach lower glycemic objectives than those recommended by the Canadian Diabetes Association: fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L.

Treatment:

Procedure: Low glycemic control