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

Vastra Gotaland Region117 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

117

Conditions

Type1diabetes

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in HbA1c

Change in HbA1c from baseline to week 18

Time frame: from baseline to 18 weeks

Secondary Outcomes

Time in Range

Change in Time in Range (4-10mmol/l) and from Baseline to week 18

Time frame: from baseline to 18 weeks

Mean glucose levels

Change in mean glucose levels from baseline to 18

Time frame: from baseline to 18 weeks

Time above range

Change in time above range (glucose values above 10mmol/L) from baseline to 18 weeks

Time frame: from baseline to 18 weeks

HbA1c at week 32

Change in HbA1c from baseline to week 32

Time frame: From baseline to 18 weeks

HbA1c at week 52

Change in HbA1c from baseline to week 52

Time frame: From baseline to 52 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes