Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-26 @ 1:13 PM
Study NCT ID:
NCT03474393
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2018-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Evaluation of Systematic Intensive Therapy Using CGM/FGM in Clinical Diabetes Care
Sponsor:
Vastra Gotaland Region
Organization:
Study Overview
Official Title:
A Randomised Trial of Evaluating a Systematic Intensive Therapy Using Continuous Glucose Monitoring (CGM) and Flash Glucose Monitoring (FGM) in Clinical Diabetes Care
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to analyse if intensive systematic treatment via internet and telephone during 4 months improved HbA1c for persons with type 1 diabetes which are already treated with CGM or FGM, and if the effect continuous for 1-2 years after the intervention stops. Time in Hypoglycaemia, treatment satisfaction, Diabetes distress and hypoglycaemia fear will even be analysed.
A randomised, non-blinded, multi-centre, clinical study for persons with type 1 diabetes and hbA1c ≥ 58mmol/mol and treated with CGM or FGM.
The control group continuous its normal diabetes care with study visits at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.
The intervention group will have contact with the study team on a weekly basis, when mean blood glucose levels the previous week are elevated. They will receive help with analysing data and advice on how to improve their glucose values. They will even meet the study team at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.
A randomised, non-blinded, multi-centre, clinical study for persons with type 1 diabetes and hbA1c ≥ 58mmol/mol and treated with CGM or FGM.
The control group continuous its normal diabetes care with study visits at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.
The intervention group will have contact with the study team on a weekly basis, when mean blood glucose levels the previous week are elevated. They will receive help with analysing data and advice on how to improve their glucose values. They will even meet the study team at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: