Intermittent glucose monitoring for the management of gestational diabetes mellitus

Not Applicable

• Conditions: Gestational diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN42125256
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37434220/ (added 12/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-07
• Last Update Posted: 4 March 2024
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Aged 16 - 55 years old
2. GDM diagnosed at any gestation >12 weeks per NICE guidelines: oral glucose tolerance test demonstrating a fasting plasma glucose level of 5.6 mmol/litre or above or a 2-hour plasma glucose level of 7.8 mmol/litre or above
3. Up to 32+0 weeks of gestation
4. Diagnosed within the last 14 days
5. Primiparous or multiparous
6. Singleton pregnancy
7. Not met NICE glucose targets with lifestyle modification of fasting glucose below 5.3mmol/litre, 1 hour after meals below 7.8mmol/l OR 2 hours after meals below 6.4mmol/litre
8. Commenced insulin and/or at least 500mg/day of metformin
9. Able to give informed consent to participate

Exclusion Criteria

1. Aged <16 or > 55 years old
2. Pre-existing overt diabetes (OGTT- fasting =7 mmol/L or 2 hour =11.1 mmol/Lor HbA1C >48)
3. >32+0 weeks gestation
4. Diagnosis of GDM >14 days
5. Chronic kidney disease
6. Psychiatric inpatient treatment
7. History of bariatric surgery or other surgeries that induce malabsorption
8. Long-term use(>2 weeks) of systemic steroids within 2 weeks prior to enrolment
9. Multiple pregnancies
10. Met NICE glucose targets with lifestyle modification
11. Not prescribed insulin or at least 500mg/day of metformin
12. Unable to give informed consent to participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility outcomes measured using data recorded in the study screening log at the end of the study:<br>1. Absolute number of recruits<br>2. Recruitment rate<br>3. Number of women invited to study<br>4. Number of women meeting eligibility criteria<br>5. Follow-up rate