Diabetes Mellitus, Type 1MDDCNCT01774149
Model Driven Diabetes Care
A study testing Few Touch Application and Diastat in people with Diabetes Mellitus, Type 1, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Patients with Diabetes Mellitus Type 1 using electronic self-help tools typically registers a large amount of data on their disease. The study intends to see if giving advanced feedback on these data can improve their blood glucose management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Few Touch Application and Diastat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis with Diabetes Mellitus type 1 for at least one year.
- Age over 18 years
- Has basic familiarity with mobile phones, and uses mobile phone on a daily basis.
Who cannot join
- Severe complications due to their diabetes.
- Unable to understand or conform to the guidelines when presented with the phone's software.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Data Driven Feedback as a Method to Improve Glycaemic Control in Type 1 Diabetes
Patients with Diabetes Mellitus Type 1 using electronic self-help tools typically registers a large amount of data on their disease. The study intends to see if giving advanced feedback on these data can improve their blood glucose management.
Read the detailed description
All patients will be given access to a mobile phone with the diabetes diary known as the Few Touch Application (FTA) installed. They may use either their own compatible Android handsets, or provided handsets. The study uses a delayed start design. Participants are randomized into two groups, who get access to the module "Diastat" after 4 and 12 weeks post-enrollment respectively. Each group uses the FTA with Diastat for 8 weeks post-intervention (i.e. access to Diastat).
Diastat is a module within FTA that provides data-driven feedback to the patients using their own data. This module is based on the data recorded in a previous trial [1]. Three submodules are part of Diastat; Periodicity detection and visualization, multiscale trend detection based on the c-SiZer algorithm [2], and situation matching for insulin dosage [3].
- Skrøvseth SO et al, Diabetes Technol Ther (2012)
- Skrøvseth SO et al, PLoS ONE (2012)
- Skrøvseth SO et al, Accepted for Advanced Technologies and Treatments for Diabetes, Paris, France, 2013.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Few Touch Application, Diastat
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Few Touch ApplicationDevice
Also called Diabetesdagboka
Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
DiastatDevice
Users get the Few Touch Application with Diastat module activated.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Diastat | Active comparator | Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment. Receives: Device: Few Touch Application; Device: Diastat |
| Diastat | Experimental | Few Touch Application with Diastat module turned on in week 4 post-enrollment. Receives: Device: Few Touch Application; Device: Diastat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12.
The number of self-measured blood glucose values < 4 mmol/L (72 mg/dL) or > 15 mmol/L (270 mg/dL) will be recorded during baseline (first 4 weeks post-enrollment/start of study) and during weeks 8-12 post-enrollment for all participants.
Measured: Up to 12 weeks post-enrollment
Secondary outcomes (1)
Change in HbA1c
HbA1c will be measured at the start of the study (week 1 post-enrollment) and during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group).
Measured: up to 20 weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso, The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Stein Olav Skrøvseth, PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774149
- Sponsor's protocol ID
- 2011/1939 (REK)
- Acronym
- MDDC
- Status last verified
- Aug 2015
- First submitted
- 11 Jan 2013
- Last updated
- 16 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Skrovseth SO, Arsand E, Godtliebsen F, Hartvigsen G. Mobile phone-based pattern recognition and data analysis for patients with type 1 diabetes. Diabetes Technol Ther. 2012 Dec;14(12):1098-104. doi: 10.1089/dia.2012.0160. Epub 2012 Oct 4.
PubMed 23035775Skrovseth SO, Arsand E, Godtliebsen F, Joakimsen RM. Model driven mobile care for patients with type 1 diabetes. Stud Health Technol Inform. 2012;180:1045-9.
PubMed 22874353Arsand E, Froisland DH, Skrovseth SO, Chomutare T, Tatara N, Hartvigsen G, Tufano JT. Mobile health applications to assist patients with diabetes: lessons learned and design implications. J Diabetes Sci Technol. 2012 Sep 1;6(5):1197-206. doi: 10.1177/193229681200600525.
PubMed 23063047Skrovseth SO, Bellika JG, Godtliebsen F. Causality in scale space as an approach to change detection. PLoS One. 2012;7(12):e52253. doi: 10.1371/journal.pone.0052253. Epub 2012 Dec 27.
PubMed 23300626Skrovseth SO, Arsand E, Godtliebsen F, Joakimsen RM. Model-driven diabetes care: study protocol for a randomized controlled trial. Trials. 2013 May 14;14:139. doi: 10.1186/1745-6215-14-139.
PubMed 23672413Skrovseth SO, Arsand E, Godtliebsen F, Joakimsen RM. Data-Driven Personalized Feedback to Patients with Type 1 Diabetes: A Randomized Trial. Diabetes Technol Ther. 2015 Jul;17(7):482-9. doi: 10.1089/dia.2014.0276. Epub 2015 Mar 9.
PubMed 25751133
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Driven Feedback as a Method to Improve Glycaemic Control in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01774149
- Acronym / sponsor ID
- MDDC / 2011/1939 (REK)
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso, The Research Council of Norway
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Posted 16 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Diabetes Mellitus Type 1 using electronic self-help tools typically registers a large amount of data on their disease. The study intends to see if giving advanced feedback on these data can improve their blood glucose management.
Detailed description
All patients will be given access to a mobile phone with the diabetes diary known as the Few Touch Application (FTA) installed. They may use either their own compatible Android handsets, or provided handsets. The study uses a delayed start design. Participants are randomized into two groups, who get access to the module "Diastat" after 4 and 12 weeks post-enrollment respectively. Each group uses the FTA with Diastat for 8 weeks post-intervention (i.e. access to Diastat).
Diastat is a module within FTA that provides data-driven feedback to the patients using their own data. This module is based on the data recorded in a previous trial [1]. Three submodules are part of Diastat; Periodicity detection and visualization, multiscale trend detection based on the c-SiZer algorithm [2], and situation matching for insulin dosage [3].
- Skrøvseth SO et al, Diabetes Technol Ther (2012)
- Skrøvseth SO et al, PLoS ONE (2012)
- Skrøvseth SO et al, Accepted for Advanced Technologies and Treatments for Diabetes, Paris, France, 2013.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Diastat | Active comparator | Device: Few Touch Application, Device: DiastatMobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment. |
| Diastat | Experimental | Device: Few Touch Application, Device: DiastatFew Touch Application with Diastat module turned on in week 4 post-enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis with Diabetes Mellitus type 1 for at least one year.
- Age over 18 years
- Has basic familiarity with mobile phones, and uses mobile phone on a daily basis.
Key exclusion criteria (2 listed)
- Severe complications due to their diabetes.
- Unable to understand or conform to the guidelines when presented with the phone's software.
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 |
|---|---|---|
| Few Touch ApplicationAlso: DiabetesdagbokaUsers get access to the regular version of the Few Touch Application for Type 1 Diabetes. | Device | Delayed Diastat, Diastat |
| DiastatUsers get the Few Touch Application with Diastat module activated. | Device | Delayed Diastat, Diastat |
Primary outcome
Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12.
Time frame: Up to 12 weeks post-enrollment
The number of self-measured blood glucose values < 4 mmol/L (72 mg/dL) or > 15 mmol/L (270 mg/dL) will be recorded during baseline (first 4 weeks post-enrollment/start of study) and during weeks 8-12 post-enrollment for all participants.
1 secondary outcome
Change in HbA1c
Time frame: up to 20 weeks post-enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23035775Skrovseth SO, Arsand E, Godtliebsen F, Hartvigsen G. Mobile phone-based pattern recognition and data analysis for patients with type 1 diabetes. Diabetes Technol Ther. 2012 Dec;14(12):1098-104. doi: 10.1089/dia.2012.0160. Epub 2012 Oct 4.
- Background: PubMed 22874353Skrovseth SO, Arsand E, Godtliebsen F, Joakimsen RM. Model driven mobile care for patients with type 1 diabetes. Stud Health Technol Inform. 2012;180:1045-9.
- Background: PubMed 23063047Arsand E, Froisland DH, Skrovseth SO, Chomutare T, Tatara N, Hartvigsen G, Tufano JT. Mobile health applications to assist patients with diabetes: lessons learned and design implications. J Diabetes Sci Technol. 2012 Sep 1;6(5):1197-206. doi: 10.1177/193229681200600525.
- Background: PubMed 23300626Skrovseth SO, Bellika JG, Godtliebsen F. Causality in scale space as an approach to change detection. PLoS One. 2012;7(12):e52253. doi: 10.1371/journal.pone.0052253. Epub 2012 Dec 27.
- Background: PubMed 23672413Skrovseth SO, Arsand E, Godtliebsen F, Joakimsen RM. Model-driven diabetes care: study protocol for a randomized controlled trial. Trials. 2013 May 14;14:139. doi: 10.1186/1745-6215-14-139.
- Derived from this study: PubMed 25751133Skrovseth SO, Arsand E, Godtliebsen F, Joakimsen RM. Data-Driven Personalized Feedback to Patients with Type 1 Diabetes: A Randomized Trial. Diabetes Technol Ther. 2015 Jul;17(7):482-9. doi: 10.1089/dia.2014.0276. Epub 2015 Mar 9.
Related trials for Diabetes Mellitus, Type 1
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Recruiting
Starting Technology in At Risk Type 1 Diabetes Study
Diabetes Mellitus, Type 1
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
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.
Stein Olav Skrøvseth, PhD principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Few Touch Application and Diastat in people with Diabetes Mellitus, Type 1, run by University Hospital of North Norway at 1 site in Norway.
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 3 inclusion and 2 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 16 Sep 2015. 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 Norway. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12. (time frame: Up to 12 weeks post-enrollment). 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 NCT01774149, which also lists 6 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 16 Sep 2015.