An interventional study of systematic intensive therapy in Type1diabetes, sponsored by Vastra Gotaland Region. Completed at 1 site in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-18.
Sponsored by Vastra Gotaland Region · Not applicable, Interventional, and Treatment
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Among 11 studies in Diabetes Mellitus, Type 1 by Vastra Gotaland Region — 2 open to participants now, 3 under way, none of them phase 3. Diabetes Mellitus, Type 1 · Vastra Gotaland Region.
Among the 11 studies in Diabetes Mellitus, Type 1 by Vastra Gotaland Region, this one is the 4th largest by enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2018, is one of 10 with no phase, and was the 7th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →2 of the 11 studies in Diabetes Mellitus, Type 1 by Vastra Gotaland Region are open now, in 1 country. Recruiting first, the newest first:
Vastra Gotaland Region · Sites in Sweden
Ages 18+
Vastra Gotaland Region · Sites in Sweden
Ages 18–100
By country, each count listing its studies:
Of the 412 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 258 (63%) stop at 75 or younger; 185 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2018.
This study's enrollment of 117 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 78 across the 10 interventional studies, 84 across the 1 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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Vastra Gotaland Region is the lead sponsor of 276 studies on the registry; 110 are open to participants now.
1 of the studies in Diabetes Mellitus, Type 1 by Vastra Gotaland Region that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05132179Vastra Gotaland RegionTreating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan | 2026-12-31 |
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Among the 11 studies in Diabetes Mellitus, Type 1 by Vastra Gotaland Region, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Continue with their normal diabetes care. Come in for control visits
Intensive Internet and telephone contact for 4 months and Control visits
Other: systematic intensive therapy
intensive telephone och internet Contact with diabetes nurse for coaching and guidance over 4 months and 4 Control visits
Change in HbA1c
Change in HbA1c from baseline to week 18
Time frame: from baseline to 18 weeks
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
Mean Glucose at week 32 and 52
Change in mean glucose from baseline to week 32 and 52
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline to weeks 18, 32 and 52
Ran from Nov 2018 to primary completion in Dec 2023, 61 months.
Of 845 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 61 months is above that.
Counting every sponsor, half of 950 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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