Type 2 DiabetesNCT05633628
Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes
A study testing Periodic CGM group with data analysis report- Intervention group in people with Type 2 Diabetes, run by Sophiahemmet University at 1 site in Sweden.
Trial summary
The aim of this randomised controlled trial is to investigate the effectiveness of periodic CGM (continuous glucose monitoring) to support a person-centered approach versus self-monitoring of blood glucose (SMBG) in adults with type 2 diabetes on glucose control and patient reported outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Periodic CGM group with data analysis report- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 18-80 years
- Type 2 diabetes with a duration of > 6 months
- HbA1c 45-70 mmol/mol
- Have a smartphone
- Experience of self-monitoring of blood glucose prior to the study start
Who cannot join
- Prandial insulin
- Pregnancy or planning pregnancy during the study
- Breastfeeding
- Renal disease with estimated glomerular filtration rate (eGFR) <45 mL/ min/1.73 m2
- Active malignancy or under investigation for malignancy
- Severe visual impairment
Show all 12Show fewer
- Severe skin allergy that inhibits the use of a continuous glucose monitoring device
- Glucocorticoids (systemic)
- Planned or currently using weight reduction medications, programs, or surgery
- Cognitively or psychologically unable to participate and read instructions
- Enrolled in other clinical trials
- Eating disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sophiahemmet University
Stockholm
Unn-Britt Johansson, PhD
About this study
Official title: Periodic Continuous Glucose Monitoring to Support a Person-centered Approach During Diabetes Consultations in Patients With Type 2 Diabetes- A Randomised Controlled Study
The aim of this randomised controlled trial is to investigate the effectiveness of periodic CGM (continuous glucose monitoring) to support a person-centered approach versus self-monitoring of blood glucose (SMBG) in adults with type 2 diabetes on glucose control and patient reported outcomes.
Read the detailed description
This is a 16-week prospective, multicenter, randomised, open-labelled, two-armed study in adults with type 2 diabetes conducted at primary care practices in Sweden.
Periodic CGM group- Intervention group:
The participants in the intervention group will be provided with FreeStyle Libre (Abbott Diabetes Care). Participants wear the sensor and check their glucose level for a period of 28 days (14 days X 2) during week 0-4 and week 10-13.Patient's measurement data from the FreeStyle Libre system 2 will be transferred to the OneTwo Analytics (DDA) analysis tool for an automated analysis and this Insight report will be presented to the participants at visit week 4 (digital) and at visit week 16 (clinical). The diabetes nurse and the patient reviews and discuss trends, patterns, and challenges to support the person's self-care management of their type 2 diabetes. This approach is intended to facilitate communication and patient participation and create the conditions for shared informed decisions and health planning.
Self-monitoring of blood glucose, SMBG and usual care - Control Group The participants in the control group perform SMBG testing as usual including fasting, pre- or post-prandial measurements. They also receive usual care which comprises consultation with physician diabetes specialist or diabetes nurse depending on individual health care needs.
- Conditions
- Type 2 Diabetes
- Being tested
- Periodic CGM group with data analysis report- Intervention group
- Keywords
- CGM, Personcentered care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodic CGM group with data analysis report- Intervention groupBehavioural
The patients are also instructed to continue to perform SMBG by finger prick if they experience symptoms of hypo- or hyperglycemia. During visit 0 (baseline) the patients is also instructed about how they can log in to the National Diabetes Register (NDR) to access their own NDR's recorded data and use the diabetes questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Periodic CGM- Intervention group | Experimental | The participants in the intervention group will be provided with FreeStyle Libre (Abbott Diabetes Care). Participants wear the sensor and check their glucose level for a period of 28 days (14 days X 2) during week 0-4 and week 10-13.Patient's measurement data from the FreeStyle Libre system will be transferred to the OneTwo Analytics (DDA) analysis tool for an automated analysis and this Insight report will be presented to the participants at visit week 4 (digital) and at visit week 16 (clinical). The diabetes nurse and the patient reviews and discuss trends, patterns, and challenges to support the person's self-management care of their type 2 diabetes. This approach is intended to facilitate communication and patient participation and create the conditions for shared informed decisions and health planning. Receives: Behavioral: Periodic CGM group with data analysis report- Intervention group |
| Self-monitoring of blood glucose, SMBG and usual care - Control Group | No intervention | The participants in the control group perform SMBG testing as usual including fasting, pre- or post-prandial measurements. They also receive usual care which comprises consultation with physician diabetes specialist or diabetes nurse depending on individual health care needs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
mmol/mol
Measured: change at week 16
Secondary outcomes (16)
Percentage of time spent in range (Glucose)
3.9-10 mmol/l as analyzed by OneTwo Analytics CE marked Decision support Clinic
Measured: change first 28 days in the study compared with the last 28 days
Percentage time spent in hyperglycaemia
> 10 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic
Measured: change first 28 days in the study compared with the last 28 days
Percentage time spent in hypoglycaemia
< 3.9 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic
Measured: change first 28 days in the study compared with the last 28 days
Average glucose value
mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic
Measured: change first 28 days in the study compared with the last 28 days
Standard deviation for glucose value
SD as analyzed by OneTwo Analytics CE marked Decision support Clinic
Measured: change first 28 days in the study compared with the last 28 days
Percentage time in euglycemia, time in target
3.9-8.0 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic
Measured: change first 28 days in the study compared with the last 28 days
Number of hyperglycemic episodes per day
Number of hyperglycemic episodes per day as analyzed by OneTwo Analytics CE marked Decision support Clinic
Measured: change first 28 days in the study compared with the last 28 days
Number of hypoglycemic episodes per day
Number of hypoglycemic episodes per day as analyzed by OneTwo Analytics CE marked Decision support Clinic
Measured: change first 28 days in the study compared with the last 28 days
Data availability in % of all time
Data availability in % of all time as analyzed by OneTwo Analytics CE marked Decision support Clinic
Measured: change first 28 days in the study compared with the last 28 days
Prandial delta within 2 hours, post - pre-prandial values for breakfast, lunch and dinner.
Prandial delta within 2 hours, post - pre-prandial values for breakfast, lunch and dinner as analyzed by OneTwo Analytics CE marked Decision support Clinic
Measured: change first 28 days in the study compared with the last 28 days
Postprandial peak during 2 hours for breakfast, lunch and dinner.
Postprandial peak during 2 hours for breakfast, lunch and dinner as analyzed by OneTwo Analytics CE marked Decision support Clinic
Measured: change first 28 days in the study compared with the last 28 days
Night-time insulin effect
Night-time insulin effect as analyzed by OneTwo Analytics CE marked Decision support Clinic
Measured: change first 28 days in the study compared with the last 28 days
Fasting glucose level
Fasting glucose level as analyzed by OneTwo Analytics CE marked Decision support Clinic
Measured: change first 28 days in the study compared with the last 28 days
The Diabetes Treatment Satisfaction questionnaire
Includes eight items related to the diabetes treatment over the past weeks.
Measured: change at week 16
WHO-5 Well-Being Index
Brief well-being questionnaire with five items in relation to previous 2 weeks
Measured: change at week 16
The Patient Preferences for Patient Participation (4Ps)
The 4Ps is a questionnaire including 12 items comprising patient´s preferences as well as experiences.
Measured: change at week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start1 Feb 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sophiahemmet University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Diabetes Foundation, OneTwo Analytics AB, Sophiahemmet
- Responsible party
- Principal investigator, Unn-Britt Johansson, Sophiahemmet University
- Investigators
- Unn-Britt Johansson, Principal investigator, Sophiahemmet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633628
- Sponsor's protocol ID
- Periodic Glucose Insights
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodic Continuous Glucose Monitoring to Support a Person-centered Approach During Diabetes Consultations in Patients With Type 2 Diabetes- A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05633628
- Acronym / sponsor ID
- Periodic Glucose Insights
- Conditions
- Type 2 Diabetes
- Keywords
- CGM, Personcentered care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sophiahemmet UniversityUniversity, hospital or other
- Collaborators
- Swedish Diabetes Foundation, OneTwo Analytics AB, Sophiahemmet
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Dec 2022 (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.
The aim of this randomised controlled trial is to investigate the effectiveness of periodic CGM (continuous glucose monitoring) to support a person-centered approach versus self-monitoring of blood glucose (SMBG) in adults with type 2 diabetes on glucose control and patient reported outcomes.
Detailed description
This is a 16-week prospective, multicenter, randomised, open-labelled, two-armed study in adults with type 2 diabetes conducted at primary care practices in Sweden.
Periodic CGM group- Intervention group:
The participants in the intervention group will be provided with FreeStyle Libre (Abbott Diabetes Care). Participants wear the sensor and check their glucose level for a period of 28 days (14 days X 2) during week 0-4 and week 10-13.Patient's measurement data from the FreeStyle Libre system 2 will be transferred to the OneTwo Analytics (DDA) analysis tool for an automated analysis and this Insight report will be presented to the participants at visit week 4 (digital) and at visit week 16 (clinical). The diabetes nurse and the patient reviews and discuss trends, patterns, and challenges to support the person's self-care management of their type 2 diabetes. This approach is intended to facilitate communication and patient participation and create the conditions for shared informed decisions and health planning.
Self-monitoring of blood glucose, SMBG and usual care - Control Group The participants in the control group perform SMBG testing as usual including fasting, pre- or post-prandial measurements. They also receive usual care which comprises consultation with physician diabetes specialist or diabetes nurse depending on individual health care needs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodic CGM- Intervention group | Experimental | Behavioral: Periodic CGM group with data analysis report- Intervention groupThe participants in the intervention group will be provided with FreeStyle Libre (Abbott Diabetes Care). Participants wear the sensor and check their glucose level for a period of 28 days (14 days X 2) during week 0-4 and week 10-13.Patient's measurement data from the FreeStyle Libre system will be transferred to the OneTwo Analytics (DDA) analysis tool for an automated analysis and this Insight report will be presented to the participants at visit week 4 (digital) and at visit week 16 (clinical). The diabetes nurse and the patient reviews and discuss trends, patterns, and challenges to support the person's self-management care of their type 2 diabetes. This approach is intended to facilitate communication and patient participation and create the conditions for shared informed decisions and health planning. |
| Self-monitoring of blood glucose, SMBG and usual care - Control Group | No intervention | –The participants in the control group perform SMBG testing as usual including fasting, pre- or post-prandial measurements. They also receive usual care which comprises consultation with physician diabetes specialist or diabetes nurse depending on individual health care needs. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-80 years
- Type 2 diabetes with a duration of > 6 months
- HbA1c 45-70 mmol/mol
- Have a smartphone
- Experience of self-monitoring of blood glucose prior to the study start
Key exclusion criteria (12 listed)
- Prandial insulin
- Pregnancy or planning pregnancy during the study
- Breastfeeding
- Renal disease with estimated glomerular filtration rate (eGFR) <45 mL/ min/1.73 m2
- Active malignancy or under investigation for malignancy
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 |
|---|---|---|
| Periodic CGM group with data analysis report- Intervention groupThe patients are also instructed to continue to perform SMBG by finger prick if they experience symptoms of hypo- or hyperglycemia. During visit 0 (baseline) the patients is also instructed about how they can log in to the National Diabetes Register (NDR) to access their own NDR's recorded data and use the diabetes questionnaire. | Behavioural | Periodic CGM- Intervention group |
Primary outcome
HbA1c
Time frame: change at week 16
mmol/mol
16 secondary outcomes
Percentage of time spent in range (Glucose)
Time frame: change first 28 days in the study compared with the last 28 days
Percentage time spent in hyperglycaemia
Time frame: change first 28 days in the study compared with the last 28 days
Percentage time spent in hypoglycaemia
Time frame: change first 28 days in the study compared with the last 28 days
Average glucose value
Time frame: change first 28 days in the study compared with the last 28 days
Standard deviation for glucose value
Time frame: change first 28 days in the study compared with the last 28 days
Percentage time in euglycemia, time in target
Time frame: change first 28 days in the study compared with the last 28 days
Number of hyperglycemic episodes per day
Time frame: change first 28 days in the study compared with the last 28 days
Number of hypoglycemic episodes per day
Time frame: change first 28 days in the study compared with the last 28 days
Data availability in % of all time
Time frame: change first 28 days in the study compared with the last 28 days
Prandial delta within 2 hours, post - pre-prandial values for breakfast, lunch and dinner.
Time frame: change first 28 days in the study compared with the last 28 days
Postprandial peak during 2 hours for breakfast, lunch and dinner.
Time frame: change first 28 days in the study compared with the last 28 days
Night-time insulin effect
Time frame: change first 28 days in the study compared with the last 28 days
Fasting glucose level
Time frame: change first 28 days in the study compared with the last 28 days
The Diabetes Treatment Satisfaction questionnaire
Time frame: change at week 16
WHO-5 Well-Being Index
Time frame: change at week 16
The Patient Preferences for Patient Participation (4Ps)
Time frame: change at week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Unn-Britt Johansson principal investigator
Sophiahemmet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodic CGM group with data analysis report- Intervention group in people with Type 2 Diabetes, run by Sophiahemmet University 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Unn-Britt Johanssson, Professor (+4684062902, unn-britt.johansson@shh.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: change at week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.