Diabetes Mellitus, Type 1DiaTastNCT03083899
The Diabetes Patient Takes Responsibility
A study testing Out-patient clinic on demand (patient-initiated) and Scheduled out-patient clinic in people with Diabetes Mellitus, Type 1 and Patient Reported Outcome, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial summary
People with Type 1 diabetes (T1D) are randomized to follow the normal scheduled visit procedure in the outpatient clinic OR to have open access to the clinic, i.e. they can get an appointment with a nurse or doctor within defined time intervals via telephone, e-mail or apps. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Patient Reported Outcome, Health Care Economics and Organizations
- What is being tested?
- Out-patient clinic on demand (patient-initiated) and Scheduled out-patient clinic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 357 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2017to 22 Dec 2019
- 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
- Type 1 diabetes 18 - 80 years Multiple injections or Insulin pump therapy
Who cannot join
- Newly diagnosed T1D Psychiatric illness Need for translation Unstable conditions such as progressive retinopathy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hospital of South West Jutland, University hospital of Southern Denmark
Esbjerg, 6700
About this study
Official title: DiaTast - Patient Reported Experience in a New Out-patient Structure With Patient-initiated Visits
People with Type 1 diabetes (T1D) are randomized to follow the normal scheduled visit procedure in the outpatient clinic OR to have open access to the clinic, i.e. they can get an appointment with a nurse or doctor within defined time intervals via telephone, e-mail or apps. Patient-reported outcomes (patient satisfaction and experience, QoL) clinical variables (HbA1c, blood pressure etc.) and use of human resources (doctors, diabetes-nurses and diet physicians) are monitored.
Read the detailed description
This is a 24 month prospective randomized controlled trial. People with Type 1 diabetes (T1D) are randomized to two groups: (i) Patients randomized to the control group receive their standard diabetes care and are seen in the out-patient clinic with regular intervals (typically a diabetes nurse every 3-4 month and a diabetes doctor once a year. (ii) Patients randomized to the intervention group are not called for at fixed time points. They can arrange visits in the diabetes clinic whenever they feel the need to do so. The have a guarantee for a consultation with a diabetes nurse within one week and with a diabetes doctor or diet physician within two weeks. Questionnaires (a specific questionnaire focused on patient satisfaction developed for the study and AddQoL) are filled in at time 0 and 24 month. Blood samples for diabetes-related variables (HbA1c, lipid status), blood pressure, body weight etc. are likewise recorded at time 0 and 24 month. Economic and time requirements are evaluated at 24 month.
- Conditions
- Diabetes Mellitus, Type 1, Patient Reported Outcome, Health Care Economics and Organizations
- Being tested
- Out-patient clinic on demand (patient-initiated), Scheduled out-patient clinic
- Keywords
- Diabetes, Organization, Out-patient control
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Out-patient clinic on demand (patient-initiated)Other
Free use of any resources in the out-patient clinic
Scheduled out-patient clinicOther
Scheduled use of the out-patient clinic
| Study group | Role | What they receive |
|---|---|---|
| Diatast | Experimental | Free patient-initiated use of out-patient services Receives: Other: Out-patient clinic on demand (patient-initiated) |
| Control | Placebo comparator | Scheduled diabetes control Receives: Other: Scheduled out-patient clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcome
Questionnaire regarding satisfaction of the out-patient clinic
Measured: 24 month
Secondary outcomes (5)
Clinical diabetes variables 1
HbA1c
Measured: 24 month
Health Care Economy
Use of resources in the out-patient clinic
Measured: 24 month
Clinical diabetes variables 2
Blood pressure
Measured: 24 month
Clinical diabetes variables 3
Lipids
Measured: 24 month
Diabetes Dependent quality of Life
Questionnaire
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start1 Mar 2017
- Primary completion22 Dec 2019
- Study completion22 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claus Bogh Juhl, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Claus B Juhl, MD PhD, Principal investigator, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083899
- Sponsor's protocol ID
- Diatast
- Acronym
- DiaTast
- Status last verified
- Dec 2020
- First submitted
- 3 Mar 2017
- Last updated
- 14 Dec 2020
- 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 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiaTast - Patient Reported Experience in a New Out-patient Structure With Patient-initiated Visits
- ClinicalTrials.gov ID
- NCT03083899
- Acronym / sponsor ID
- DiaTast / Diatast
- Conditions
- Diabetes Mellitus, Type 1, Patient Reported Outcome, Health Care Economics and Organizations
- Keywords
- Diabetes, Organization, Out-patient control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 22 Dec 2019 (actual)
- First posted
- 20 Mar 2017 (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.
People with Type 1 diabetes (T1D) are randomized to follow the normal scheduled visit procedure in the outpatient clinic OR to have open access to the clinic, i.e. they can get an appointment with a nurse or doctor within defined time intervals via telephone, e-mail or apps. Patient-reported outcomes (patient satisfaction and experience, QoL) clinical variables (HbA1c, blood pressure etc.) and use of human resources (doctors, diabetes-nurses and diet physicians) are monitored.
Detailed description
This is a 24 month prospective randomized controlled trial. People with Type 1 diabetes (T1D) are randomized to two groups: (i) Patients randomized to the control group receive their standard diabetes care and are seen in the out-patient clinic with regular intervals (typically a diabetes nurse every 3-4 month and a diabetes doctor once a year. (ii) Patients randomized to the intervention group are not called for at fixed time points. They can arrange visits in the diabetes clinic whenever they feel the need to do so. The have a guarantee for a consultation with a diabetes nurse within one week and with a diabetes doctor or diet physician within two weeks. Questionnaires (a specific questionnaire focused on patient satisfaction developed for the study and AddQoL) are filled in at time 0 and 24 month. Blood samples for diabetes-related variables (HbA1c, lipid status), blood pressure, body weight etc. are likewise recorded at time 0 and 24 month. Economic and time requirements are evaluated at 24 month.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diatast | Experimental | Other: Out-patient clinic on demand (patient-initiated)Free patient-initiated use of out-patient services |
| Control | Placebo comparator | Other: Scheduled out-patient clinicScheduled diabetes control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 1 diabetes 18 - 80 years Multiple injections or Insulin pump therapy
Key exclusion criteria (1 listed)
- Newly diagnosed T1D Psychiatric illness Need for translation Unstable conditions such as progressive retinopathy
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 |
|---|---|---|
| Out-patient clinic on demand (patient-initiated)Free use of any resources in the out-patient clinic | Other | Diatast |
| Scheduled out-patient clinicScheduled use of the out-patient clinic | Other | Control |
Primary outcome
Patient reported outcome
Time frame: 24 month
Questionnaire regarding satisfaction of the out-patient clinic
5 secondary outcomes
Clinical diabetes variables 1
Time frame: 24 month
Health Care Economy
Time frame: 24 month
Clinical diabetes variables 2
Time frame: 24 month
Clinical diabetes variables 3
Time frame: 24 month
Diabetes Dependent quality of Life
Time frame: 24 month
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 14 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 1
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Obesity or Overweight
Not yet recruitingPhase 1/2
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
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.
Claus B Juhl, MD PhD principal investigator
Esbjerg Hospital - University Hospital of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Out-patient clinic on demand (patient-initiated) and Scheduled out-patient clinic in people with Diabetes Mellitus, Type 1 and Patient Reported Outcome, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
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 1 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 14 Dec 2020. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Patient reported outcome (time frame: 24 month). 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 14 Dec 2020.