Diabetes Mellitus, Type 2NCT04216875
Best Practice Study of Diabetes Type 2 Management in Primary Care in Switzerland
An observational study of Diabetes Mellitus, Type 2 and Primary Care, run by QualiCCare at 1 site in Switzerland.
Trial summary
This observational study intends to evaluate the use and adherence of different types of primary care practices to the diabetes criteria-protocol (diabetes score), developed by the Swiss Society of Endocrinology and Diabetology. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2, Primary Care
- What is being tested?
- Best Practice Diabetes Management in Primary Care
- Type of treatment
- Surgery or procedure
- How many people
- 738 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population comprises two different kinds of primary care practices who either get the intervention or have no intervention (4 groups in total): single practices with one general practioner and group practices with several general practitioners. On the practice level, the study population comprises all diabetes patients who correspond to the inclusion criteria.
Who may be able to join
- all patients in the primary care practice with a diabetes diagnosis, meaning their patient record shows that the patient either had an HbA1c value higher than 6.4 percent, takes insulin or oral antidiabetics and is treated at least during nine months in the participating primary care practice.
Who cannot join
- treatment in participating primary care practice during less than nine months (due to change of primary care provider, death, diabetes treatment solely by specialist);
- patients who do not give their patient consent to participate in study;
- patients whom the primary care provider excludes from study due to frailty, end of life or other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimisation of Treatment of Chronic Patients With Diabetes Mellitus Type 2 in Primary Care (Qualiccare Begleitforschung Zur Optimierung Der Behandlung Von Chronischen Patienten Mit Diabetes Mellitus Typ 2 in Der Grundversorgung)
This observational study intends to evaluate the use and adherence of different types of primary care practices to the diabetes criteria-protocol (diabetes score), developed by the Swiss Society of Endocrinology and Diabetology. This diabetes score comprises visits to the doctor, lifestyle consultations, clinical measures such as blood pressure, cholesterol or blood sugar, as well as measures concerning the prevention of secondary complications like kidney, eye or feet issues. The participating primary care practices need to treat 80% of their diabetes patients (their "diabetes population") in accordance to the score-criteria. In addition to the adherence to the eight score-criteria, the practices are required to also document statistically if their diabetes patients get the following medication: oral antidiabetics, insulin, blood pressure medication, statins and / flu vaccine. As this observational study is and before-and-after study, the primary care practices need to document for each of their diabetes patients the care they provided in the year before the introduction of the score-criteria and in the year following their introduction. Participating primary care practices ask their diabetes patients' consent to the documentation and anonymous transmittance of their data. Data evaluation is anonymous and on a population-based level (as opposed to individual-based). The hypothesis of the study is to prove that the implementation of evidence-based measures, such as a diabetes score can increase the treatment quality of diabetes patients in primary care practices and this increase is independent of the primary care practice structure in which it is applied.
Read the detailed description
Information of the primary care practices regarding the background and goal of the project by means of a letter and informative documentation.
Recruitment of primary care practices, divided into three different practice organisations (individual practices and group practices run on a private basis and with financial autonomy, as well as forms of joint practices with employed physicians without financial autonomy).
A signed contract between QualiCCare and participating primary care practices regulates the collaboration.
Procedure:
A baseline documentation takes place retrospectively from the training/workshop for the past 12 months, and a second, prospective documentation of the treatment is done during the following 12 months.
Training of the participating general practioners (GP) and practice coordinator on the project including evaluation software, data entry and background to the criteria.
Documentation of the treatment quality of all patients with diabetes mellitus type 2 in a practice structure that meets the inclusion criteria according to the score criteria (baseline).
After 12 months, the treatment quality of the included patients with diabetes type 2 is recorded again using the same score.
- Conditions
- Diabetes Mellitus, Type 2, Primary Care
- Being tested
- Best Practice Diabetes Management in Primary Care
- Keywords
- Best practice, optimisation of treatment, diabetes score, diabetes in primary 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.
Best Practice Diabetes Management in Primary CareProcedure or surgery
Also called Diabetes Score
Practice adherence to best practice guidelines treating diabetes patients in different primary care practices is shown in this before- and after observational study
| Study group | Role | What they receive |
|---|---|---|
| single primary care practices intervention | Independent primary care practices with one single medical doctor in the practice, usually ther owner of the practice working in his responsibility following the best practice procedure of the diabetes score. Receives: Procedure: Best Practice Diabetes Management in Primary Care | |
| primary care group practice intervention | Independent primary care practices with more than one medical doctor working in their responsibility following the best practice procedure of the diabetes score. Receives: Procedure: Best Practice Diabetes Management in Primary Care | |
| single primary care practices no intervention | Independent primary care practices with one single medical doctor in the practice, usually ther owner of the practice working in his responsibility without the intervention (not using Diabetes score) | |
| primary care group practice no intervention | Independent primary care practices with more than one medical doctor working in their responsibility without the intervention (not using Diabetes score). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score result before and after the introduction of the diabetes score criteria for treatment of diabetes patients in the primary care setting
The change is measured at baseline, before the introduction of the diabetes score criteria and one year after the introduction.
There are 8 score criteria for the good diabetes management in primary care (such as 1x/y lifestyle consultation, 1x/foot control, etc). Each criteria gets a certain number of points if 80% of the participating patients are treated in accordance to the given criteria. In total, a maximum of 100 points can be achieved. The objective is to achieved a minimum of 70% (= 70 points).
Measured: one year
Secondary outcomes (3)
Evaluation of feasibility of the implementation of the diabetes score criteria in different primary care practice types
In order to test the feasibility of the use in different primary care practice types, the diabetes score criteria (as described above) are used in independent single practices and group practices. The above mentioned diabetes score consists of 8 score criteria concerning the diabetes management in primary care. The maximum amount of points are 100. it is desirable to achieve 70/100 points, whereas the points are attributed if 80% of the participating diabetes patients in the practice are treated according the the criteria.
Measured: one year
Comparison of the diabetes treatment in regards to the different primary care settings
The resulting average score value of the diabetes treatment using the above described and mentioned diabetes score criteria in independent single primary care practices is compared with the resulting average score value of the diabetes treatment in group practices. The higher the score value, the better the treatment of diabetes patients in the respective practice structure (single or group practice).
Measured: one year
Evaluation of practice tool used for the documentation and evaluation of the diabetes score
The participating primary care practices evaluate the practice tool and give feedback in regards to practicality and applicability in the respective practice setting
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 Jan 2018
- Primary completion1 Jun 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 738 participants (actual)
Sponsor and investigators
- Lead sponsor
- QualiCCare
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Society of Endocrinology and Diabetology, Roche Diabetes Care, Sanofi, Concordia Versicherungen AG, Novo Nordisk A/S, Galenica
- Responsible party
- Sponsor
- Investigators
- Emanuel Christ, Prof., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216875
- Sponsor's protocol ID
- QualiCCare Diabetes III
- Other IDs
- BASEC Nr. 2017-01340
- Status last verified
- Aug 2025
- First submitted
- 31 Dec 2019
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christ E, Czock A, Renstrom F, Ammeter T, Ebrahimi F, Zechmann S, Kutz A, Diem P, Hauptle C, Brandle M. Evaluation of type 2 diabetes care management in nine primary care practices before and after implementation of the Criteria of Good Disease Management of Diabetes established by the Swiss Society of Endocrinology and Diabetology. Swiss Med Wkly. 2022 Jul 26;152:w30197. doi: 10.4414/smw.2022.w30197. eCollection 2022 Jul 18.
PubMed 35925612
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Treatment of Chronic Patients With Diabetes Mellitus Type 2 in Primary Care (Qualiccare Begleitforschung Zur Optimierung Der Behandlung Von Chronischen Patienten Mit Diabetes Mellitus Typ 2 in Der Grundversorgung)
- ClinicalTrials.gov ID
- NCT04216875
- Acronym / sponsor ID
- QualiCCare Diabetes III
- Conditions
- Diabetes Mellitus, Type 2, Primary Care
- Keywords
- Best practice, optimisation of treatment, diabetes score, diabetes in primary care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 738 participants (actual)
- Lead sponsor
- QualiCCareUniversity, hospital or other
- Collaborators
- Swiss Society of Endocrinology and Diabetology, Roche Diabetes Care, Sanofi, Concordia Versicherungen AG, Novo Nordisk A/S, Galenica
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 Jan 2020 (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 observational study intends to evaluate the use and adherence of different types of primary care practices to the diabetes criteria-protocol (diabetes score), developed by the Swiss Society of Endocrinology and Diabetology. This diabetes score comprises visits to the doctor, lifestyle consultations, clinical measures such as blood pressure, cholesterol or blood sugar, as well as measures concerning the prevention of secondary complications like kidney, eye or feet issues. The participating primary care practices need to treat 80% of their diabetes patients (their "diabetes population") in accordance to the score-criteria. In addition to the adherence to the eight score-criteria, the practices are required to also document statistically if their diabetes patients get the following medication: oral antidiabetics, insulin, blood pressure medication, statins and / flu vaccine. As this observational study is and before-and-after study, the primary care practices need to document for each of their diabetes patients the care they provided in the year before the introduction of the score-criteria and in the year following their introduction. Participating primary care practices ask their diabetes patients' consent to the documentation and anonymous transmittance of their data. Data evaluation is anonymous and on a population-based level (as opposed to individual-based). The hypothesis of the study is to prove that the implementation of evidence-based measures, such as a diabetes score can increase the treatment quality of diabetes patients in primary care practices and this increase is independent of the primary care practice structure in which it is applied.
Detailed description
Information of the primary care practices regarding the background and goal of the project by means of a letter and informative documentation.
Recruitment of primary care practices, divided into three different practice organisations (individual practices and group practices run on a private basis and with financial autonomy, as well as forms of joint practices with employed physicians without financial autonomy).
A signed contract between QualiCCare and participating primary care practices regulates the collaboration.
Procedure:
A baseline documentation takes place retrospectively from the training/workshop for the past 12 months, and a second, prospective documentation of the treatment is done during the following 12 months.
Training of the participating general practioners (GP) and practice coordinator on the project including evaluation software, data entry and background to the criteria.
Documentation of the treatment quality of all patients with diabetes mellitus type 2 in a practice structure that meets the inclusion criteria according to the score criteria (baseline).
After 12 months, the treatment quality of the included patients with diabetes type 2 is recorded again using the same score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| single primary care practices intervention | – | Procedure: Best Practice Diabetes Management in Primary CareIndependent primary care practices with one single medical doctor in the practice, usually ther owner of the practice working in his responsibility following the best practice procedure of the diabetes score. |
| primary care group practice intervention | – | Procedure: Best Practice Diabetes Management in Primary CareIndependent primary care practices with more than one medical doctor working in their responsibility following the best practice procedure of the diabetes score. |
| single primary care practices no intervention | – | –Independent primary care practices with one single medical doctor in the practice, usually ther owner of the practice working in his responsibility without the intervention (not using Diabetes score) |
| primary care group practice no intervention | – | –Independent primary care practices with more than one medical doctor working in their responsibility without the intervention (not using Diabetes score). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population comprises two different kinds of primary care practices who either get the intervention or have no intervention (4 groups in total): single practices with one general practioner and group practices with several general practitioners. On the practice level, the study population comprises all diabetes patients who correspond to the inclusion criteria.
Key inclusion criteria (1 listed)
- all patients in the primary care practice with a diabetes diagnosis, meaning their patient record shows that the patient either had an HbA1c value higher than 6.4 percent, takes insulin or oral antidiabetics and is treated at least during nine months in the participating primary care practice.
Key exclusion criteria (3 listed)
- treatment in participating primary care practice during less than nine months (due to change of primary care provider, death, diabetes treatment solely by specialist);
- patients who do not give their patient consent to participate in study;
- patients whom the primary care provider excludes from study due to frailty, end of life or other reasons.
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 |
|---|---|---|
| Best Practice Diabetes Management in Primary CareAlso: Diabetes ScorePractice adherence to best practice guidelines treating diabetes patients in different primary care practices is shown in this before- and after observational study | Procedure or surgery | primary care group practice intervention, single primary care practices intervention |
Primary outcome
Change in score result before and after the introduction of the diabetes score criteria for treatment of diabetes patients in the primary care setting
Time frame: one year
The change is measured at baseline, before the introduction of the diabetes score criteria and one year after the introduction. There are 8 score criteria for the good diabetes management in primary care (such as 1x/y lifestyle consultation, 1x/foot control, etc). Each criteria gets a certain number of points if 80% of the participating patients are treated in accordance to the given criteria. In total, a maximum of 100 points can be achieved. The objective is to achieved a minimum of 70% (= 70 points).
3 secondary outcomes
Evaluation of feasibility of the implementation of the diabetes score criteria in different primary care practice types
Time frame: one year
Comparison of the diabetes treatment in regards to the different primary care settings
Time frame: one year
Evaluation of practice tool used for the documentation and evaluation of the diabetes score
Time frame: one year
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 20 Aug 2025.
- Derived from this study: PubMed 35925612Christ E, Czock A, Renstrom F, Ammeter T, Ebrahimi F, Zechmann S, Kutz A, Diem P, Hauptle C, Brandle M. Evaluation of type 2 diabetes care management in nine primary care practices before and after implementation of the Criteria of Good Disease Management of Diabetes established by the Swiss Society of Endocrinology and Diabetology. Swiss Med Wkly. 2022 Jul 26;152:w30197. doi: 10.4414/smw.2022.w30197. eCollection 2022 Jul 18.
- official guideline platform of the Swiss medical Society FMHLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Emanuel Christ, Prof. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Primary Care, run by QualiCCare at 1 site in Switzerland.
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 1 inclusion and 3 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 20 Aug 2025. 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 Switzerland. 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 score result before and after the introduction of the diabetes score criteria for treatment of diabetes patients in the primary care setting (time frame: one year). 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 NCT04216875, which also lists 1 linked publication.
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 20 Aug 2025.