A Evaluation of Systematic Intensive Therapy Using CGM/FGM in Clinical Diabetes Care
NCT ID: NCT03474393
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
117 participants
INTERVENTIONAL
2018-11-01
2023-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Normal diabetes care
Continue with their normal diabetes care. Come in for control visits
No interventions assigned to this group
Systematic intensive therapy
Intensive Internet and telephone contact for 4 months and Control visits
systematic intensive therapy
intensive telephone och internet Contact with diabetes nurse for coaching and guidance over 4 months and 4 Control visits
Interventions
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systematic intensive therapy
intensive telephone och internet Contact with diabetes nurse for coaching and guidance over 4 months and 4 Control visits
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of Type 1 diabetes
* Adult patients over 18 years of age
* HbA1c ≥ 58 mmol/mol
* Currently using CGM or FGM
* To have a possibility to download and share FGM/CGM data
Exclusion Criteria
* Diabetes duration \<1 year
* Long-term Systemic glucocorticoid treatment during the last 3 months
* Planned or changed treatment the last 3 months regarding MDI vs. Insulin pump or added or stopped CGM or FGM therapy
* Current or planned pregnancy or breastfeeding during the next 12 months
* Planned move during the next 12 months making it not possible to participate in study activities
* Other reason determined by the investigator not being appropriate for participation
18 Years
80 Years
ALL
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Locations
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NU-Hosptial Group
Uddevalla, , Sweden
Countries
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References
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Olafsdottir AF, Sveen KA, Wijkman M, Hallstrom S, Nilsson PH, Sterner Isaksson S, Holmer H, Ekstrom M, Imberg H, Lind M. Systematic intensive therapy in addition to continuous glucose monitoring in adults with type 1 diabetes: a multicentre, open-label, randomised controlled trial. Lancet Reg Health Eur. 2025 Oct 16;59:101485. doi: 10.1016/j.lanepe.2025.101485. eCollection 2025 Dec.
Olafsdottir AF, Lind M. Evaluating a systematic intensive therapy using continuous glucose monitoring and intermittent scanning glucose monitoring in clinical diabetes care: a protocol for a multi-center randomized clinical trial. Front Clin Diabetes Healthc. 2023 Oct 18;4:1247616. doi: 10.3389/fcdhc.2023.1247616. eCollection 2023.
Other Identifiers
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SIT-CGM/FGM
Identifier Type: -
Identifier Source: org_study_id
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