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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal diabetes care | No Intervention | Continue with their normal diabetes care. Come in for control visits | |
| Systematic intensive therapy | Experimental | Intensive Internet and telephone contact for 4 months and Control visits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| systematic intensive therapy | Other | intensive telephone och internet Contact with diabetes nurse for coaching and guidance over 4 months and 4 Control visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c from baseline to week 18 | from baseline to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range | Change in Time in Range (4-10mmol/l) and from Baseline to week 18 | from baseline to 18 weeks |
| Mean glucose levels | Change in mean glucose levels from baseline to 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Glucose at week 32 and 52 | Change in mean glucose from baseline to week 32 and 52 | From baseline to 32 and 52 weeks |
| Time below range week 18, 32 and 52 | Change in time below range (glucose values below 4.0mmol/l) from baseline to week 18, 32 and 52 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NU-Hosptial Group | Uddevalla | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41142656 | Derived | 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. | |
| 37920192 |
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| from baseline to 18 weeks |
| Time above range | Change in time above range (glucose values above 10mmol/L) from baseline to 18 weeks | from baseline to 18 weeks |
| HbA1c at week 32 | Change in HbA1c from baseline to week 32 | From baseline to 18 weeks |
| HbA1c at week 52 | Change in HbA1c from baseline to week 52 | From baseline to 52 weeks |
| From baseline to 18, 32 and 52 weeks |
| Time above range weeks 32 and 52 | Change in time above range from baseline to 32 and 52 weeks | From baseline to weeks 32 and 52 |
| Glycaemic variability - Standard deviation | Change in glycaemic variability from baseline to 18, 32 and 52 weeks using Standard deviation | From baseline to weeks 18, 32 and 52 |
| Glycaemic variability - Coefficient of variation | Change in glycaemic variability from baseline to 18, 32 and 52 weeks using Coefficient of variation | From baseline to weeks 18, 32 and 52 |
| Glycaemic variability - Mage | Change in glycaemic variability from baseline to 18, 32 and 52 weeks using MAGE | From baseline to weeks 18, 32 and 52 |
| DTSQ | 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 | From baseline to weeks 18, 32 and 52 |
| 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 weeks 18, 32 and 52 |
| Diabetes distress scale | Change in Diabetes distress score (DDS) score from baseline to 18 and 52 weeks. DDS is a 6 pt Lickert scale with 28 questions | From baseline to weeks 18, 32 and 52 |
| Derived |
| 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. |