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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised Trial of Evaluating a Systematic Intensive Therapy Using Continuous Glucose Monitoring (CGM) and Flash Glucose Monitoring (FGM) in Clinical Diabetes Care

Conditions
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Type1diabetes

Intervention / Treatment
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* Other: systematic intensive therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Normal diabetes care<br>Continue with their normal diabetes care. Come in for control visits | |
| Experimental: Systematic intensive therapy<br>Intensive Internet and telephone contact for 4 months and Control visits | Other: systematic intensive therapy<br>* intensive telephone och internet Contact with diabetes nurse for coaching and guidance over 4 months and 4 Control visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | Change in HbA1c from baseline to week 18 and week 52 | from baseline to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Time in Range and Time in Target | Change in Time in Range (4-10mmol/l) and Time in Target (4-8mmol/l) from Baseline to week 18 and week 52 | from baseline to 52 weeks | 
| Mean glucose levels | Change in mean glucose levels from baseline to 18 and 52 weeks | from baseline to 52 weeks | 
| Glycaemic variability | Change in glycaemic variability from baseline to 18 and 52 weeks using Standard deviation, Coefficient of variation and MAGE | from baseline to 52 weeks | 
| Hypoglycaemia | Change in time in hypoglycaemia from baseline to 18 and 52 weeks | from baseline to 52 weeks | 
| Hyperglycaemia | Change in time in hyperglycaemia from baseline to 18 and 52 weeks | from baseline to 52 weeks | 
| Hypoglycaemic confidence | Change in Hypoglycaemic confidence score from baseline to 18 and 52 weeks. The hypoglycemic confidence scale is a 4pt Lickert scale with 9 questions | from baseline to 52 weeks | 
| DDS | Change in DDS score from baseline to 18 and 52 weeks. DDS is a 6 pt Lickert scale with 28 questions | from baseline to 52 weeks | 
| DTSQ | Change in DTSQs score from baseline to 18, and 52 weeks and DTSQc at 18 and 52 weeks. the DTSQ is a 7 pt Lickert scale with 8 questions. | from baseline to 52 weeks |