Type1diabetes
Conditions
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.
Interventions
OTHERsystematic intensive therapy
intensive telephone och internet Contact with diabetes nurse for coaching and guidance over 4 months and 4 Control visits
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | from baseline to 18 weeks | Change in HbA1c from baseline to week 18 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range | from baseline to 18 weeks | Change in Time in Range (4-10mmol/l) and from Baseline to week 18 |
| Mean glucose levels | from baseline to 18 weeks | Change in mean glucose levels from baseline to 18 |
| Time above range | from baseline to 18 weeks | Change in time above range (glucose values above 10mmol/L) from baseline to 18 weeks |
| HbA1c at week 32 | From baseline to 18 weeks | Change in HbA1c from baseline to week 32 |
| HbA1c at week 52 | From baseline to 52 weeks | Change in HbA1c from baseline to week 52 |
Other
| Measure | Time frame | Description |
|---|---|---|
| DTSQ | From baseline to weeks 18, 32 and 52 | Change in Diabetes Treatment and satisfaction (DTSQ) score from baseline to 18, 32 and 52 weeks. DDS is a 6 pt Lickert scale with 28 questions |
| Mean Glucose at week 32 and 52 | From baseline to 32 and 52 weeks | Change in mean glucose from baseline to week 32 and 52 |
| Diabetes distress scale | From baseline to weeks 18, 32 and 52 | Change in Diabetes distress score (DDS) score from baseline to 18 and 52 weeks. DDS is a 6 pt Lickert scale with 28 questions |
| Hypoglycaemic confidence | From baseline to weeks 18, 32 and 52 | Change in Hypoglycaemic confidence score from baseline to 18 and 52 weeks. The hypoglycemic confidence scale is a 4pt Lickert scale with 9 questions |
| Time below range week 18, 32 and 52 | From baseline to 18, 32 and 52 weeks | Change in time below range (glucose values below 4.0mmol/l) from baseline to week 18, 32 and 52 |
| Time above range weeks 32 and 52 | From baseline to weeks 32 and 52 | Change in time above range from baseline to 32 and 52 weeks |
| Glycaemic variability - Standard deviation | From baseline to weeks 18, 32 and 52 | Change in glycaemic variability from baseline to 18, 32 and 52 weeks using Standard deviation |
| Glycaemic variability - Coefficient of variation | From baseline to weeks 18, 32 and 52 | Change in glycaemic variability from baseline to 18, 32 and 52 weeks using Coefficient of variation |
| Glycaemic variability - Mage | From baseline to weeks 18, 32 and 52 | Change in glycaemic variability from baseline to 18, 32 and 52 weeks using MAGE |
Countries
Sweden
Outcome results
None listed