A Evaluation of Systematic Intensive Therapy Using CGM/FGM in Clinical Diabetes Care

Vastra Gotaland Region

Status: Completed

Conditions: Type1diabetes

Treatments: Other: systematic intensive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03474393

SIT-CGM/FGM

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management)
• 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

• Type 2 diabetes
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

Normal diabetes care

No Intervention group

Description:

Continue with their normal diabetes care. Come in for control visits

Systematic intensive therapy

Experimental group

Description:

Intensive Internet and telephone contact for 4 months and Control visits

Treatment:

Other: systematic intensive therapy