ISRCTN57579163

Individualised patient care and treatment for maternal diabetes

Understanding the glycaemic profile of maternal diabetes using continuous glucose monitoring: intensive glucose profiling to inform patient care and treatment (INFORMED)
University of Leeds·Not Applicable·ISRCTN Registry·device·Device trial
Study focus
Disease/Condition
Diabetes mellitus
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
University of Leeds
Funder
Wellcome Trust; Grant Codes: 217446/Z/19/Z
Location
United Kingdom
Timeline & enrollment
Phase
Not Applicable
Start date
Oct 12, 2020
End date
Feb 01, 2023
Enrollment
76 participants
Summary

A. Main research question: How do diet and personal factors influence glucose responses in pregnant women with pre-existing diabetes? 1. What role does diet play as a mediator of dysglycemia over the course of pregnancy? Hypothesis: Pregnant women with pre-existing diabetes consuming a well-balanced diet (e.g. low glycemic index, reduced saturated fat and high fibre intake) will have improved glycemic control and reduced dysglycemia over the course of pregnancy compared consuming to an unbalanced diet (e.g. high glycemic index, increased saturated fat and low in fibre intake). 2. Which personal characteristics drive differences in dysglycemia? Hypothesis: Personal characteristics such as younger age, lower body mass index and non-minority ethnic background will have a positive impact on (dys)glycemia in pregnant women with pre-existing diabetes. B. Nested study: How do diet and personal factors influence glucose responses after a meal in pregnant women with pre-existing diabetes? 1. What role does diet play as a mediator of post-prandial glucose response over the course of pregnancy? Hypothesis: Pregnant women with pre-existing diabetes consuming a standardised breakfast meal replacement with a low glycemic index will have improved glycemic control after the meal over the course of pregnancy compared to consuming a standardised breakfast meal replacement with a high glycemic index. 2. Which personal characteristics drive differences in dysglycemia after a meal? Hypothesis: Personal characteristics such as younger age, lower body mass index and non-minority ethnic background will have a positive impact on (dys)glycemia after a meal in pregnant women with pre-existing diabetes.

ICD-10 classifications
Diabetes mellitusUnspecified diabetes mellitusOther specified diabetes mellitusUnspecified diabetes mellitus without complicationsUnspecified diabetes mellitus with unspecified complications
Data source
Registry
ISRCTN Registry
Trial ID
ISRCTN57579163
Type
Device Trial
About this record

Access comprehensive clinical trial information for ISRCTN57579163 through Pure Global AI's free database. This Not Applicable trial is sponsored by University of Leeds and is currently status unknown. The study focuses on Diabetes mellitus. Target enrollment is 76 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ISRCTN Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.