Type1diabetesNCT03474393
A Evaluation of Systematic Intensive Therapy Using CGM/FGM in Clinical Diabetes Care
A study testing systematic intensive therapy in people with Type1diabetes, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- systematic intensive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Trial of Evaluating a Systematic Intensive Therapy Using Continuous Glucose Monitoring (CGM) and Flash Glucose Monitoring (FGM) in Clinical Diabetes Care
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.
Read more
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.
- Conditions
- Type1diabetes
- Being tested
- systematic intensive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic intensive therapyOther
intensive telephone och internet Contact with diabetes nurse for coaching and guidance over 4 months and 4 Control visits
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: systematic intensive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change in HbA1c from baseline to week 18
Measured: from baseline to 18 weeks
Secondary outcomes (5)
Time in Range
Change in Time in Range (4-10mmol/l) and from Baseline to week 18
Measured: from baseline to 18 weeks
Mean glucose levels
Change in mean glucose levels from baseline to 18
Measured: from baseline to 18 weeks
Time above range
Change in time above range (glucose values above 10mmol/L) from baseline to 18 weeks
Measured: from baseline to 18 weeks
HbA1c at week 32
Change in HbA1c from baseline to week 32
Measured: From baseline to 18 weeks
HbA1c at week 52
Change in HbA1c from baseline to week 52
Measured: From baseline to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Nov 2018
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474393
- Sponsor's protocol ID
- SIT-CGM/FGM
- Status last verified
- Feb 2024
- First submitted
- 1 Mar 2018
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41142656Olafsdottir 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.
PubMed 37920192
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of Evaluating a Systematic Intensive Therapy Using Continuous Glucose Monitoring (CGM) and Flash Glucose Monitoring (FGM) in Clinical Diabetes Care
- ClinicalTrials.gov ID
- NCT03474393
- Acronym / sponsor ID
- SIT-CGM/FGM
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal diabetes care | No intervention | –Continue with their normal diabetes care. Come in for control visits |
| Systematic intensive therapy | Experimental | Other: systematic intensive therapyIntensive Internet and telephone contact for 4 months and Control visits |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systematic intensive therapyintensive telephone och internet Contact with diabetes nurse for coaching and guidance over 4 months and 4 Control visits | Other | Systematic intensive therapy |
Primary outcome
Change in HbA1c
Time frame: from baseline to 18 weeks
Change in HbA1c from baseline to week 18
5 secondary outcomes
Time in Range
Time frame: from baseline to 18 weeks
Mean glucose levels
Time frame: from baseline to 18 weeks
Time above range
Time frame: from baseline to 18 weeks
HbA1c at week 32
Time frame: From baseline to 18 weeks
HbA1c at week 52
Time frame: From baseline to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Derived from this study: PubMed 41142656Olafsdottir 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.
- Derived from this study: PubMed 37920192Olafsdottir 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.
Related trials for Type1diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Type 1 Diabetes, Type1diabetes
RecruitingObservational study
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Type1diabetes
Active, not recruitingPhase 2
Reducing Innate Inflammation in New Onset Type 1 Diabetes
Type 1 Diabetes, type1diabetes
Recruiting
Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)
Non-Nutritive Sweetener, Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing systematic intensive therapy in people with Type1diabetes, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: from baseline to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03474393, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.