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| Name | Class |
|---|---|
| University of Tromso | OTHER |
| The Research Council of Norway | OTHER |
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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.
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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed Diastat | Active Comparator | Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment. |
|
| Diastat | Experimental | Few Touch Application with Diastat module turned on in week 4 post-enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Few Touch Application | Device | Users get access to the regular version of the Few Touch Application for Type 1 Diabetes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 weeks post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 20 weeks post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | System Usability Scale (SUS) will be applied to assess usability of the approach and recorded during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group). | up to 20 weeks post-enrollment |
| Empowerment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stein Olav Skrøvseth, PhD | University Hospital of North Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hopital of North Norway | Tromsø | 9038 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23035775 | Background | 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. | |
| 22874353 | Background | Skrovseth 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Delayed Diastat | Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment. Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes. Diastat: Users get the Few Touch Application with Diastat module activated. |
| FG001 | Diastat | Few Touch Application with Diastat module turned on in week 4 post-enrollment. Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes. Diastat: Users get the Few Touch Application with Diastat module activated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Delayed Diastat | Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment. Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes. Diastat: Users get the Few Touch Application with Diastat module activated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 14 participants in each group were active users and had sufficient data to be analyzed for the outcome. | Posted | Mean | 95% Confidence Interval | Events | Up to 12 weeks post-enrollment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delayed Diastat | Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment. Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes. Diastat: Users get the Few Touch Application with Diastat module activated. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stein Olav Skrøvseth | Norwegian Center for Integrated Care and Telemedicine | +4795805841 | stein.olav.skrovseth@telemed.no |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Diastat | Device | Users get the Few Touch Application with Diastat module activated. |
|
Diabetes Empowerment Scale-Short Form (DES-SF) will be used to assess empowerment at the start of the study (week 1 post-enrollment) and during week 12 of intervention. |
| Up to 12 weeks post-enrollment. |
| 23063047 | Background | Arsand 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. |
| 23300626 | Background | Skrovseth 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. |
| 23672413 | Background | Skrovseth 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. |
| 25751133 | Derived | Skrovseth 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. |
| BG001 |
| Diastat |
Few Touch Application with Diastat module turned on in week 4 post-enrollment. Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes. Diastat: Users get the Few Touch Application with Diastat module activated. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HbA1c | Mean | Standard Deviation | % |
|
| OG001 | Diastat | Few Touch Application with Diastat module turned on in week 4 post-enrollment. Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes. Diastat: Users get the Few Touch Application with Diastat module activated. |
|
|
| Secondary | 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). | 11 participants in each group met for measurement of HbA1c. Reasons for not meeting was not recorded. | Posted | Mean | 95% Confidence Interval | Percentage points | up to 20 weeks post-enrollment |
|
|
|
| Other Pre-specified | Usability | System Usability Scale (SUS) will be applied to assess usability of the approach and recorded during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group). | Not Posted | up to 20 weeks post-enrollment |
| Other Pre-specified | Empowerment | Diabetes Empowerment Scale-Short Form (DES-SF) will be used to assess empowerment at the start of the study (week 1 post-enrollment) and during week 12 of intervention. | Not Posted | Up to 12 weeks post-enrollment. |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Diastat | Few Touch Application with Diastat module turned on in week 4 post-enrollment. Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes. Diastat: Users get the Few Touch Application with Diastat module activated. | 0 | 15 | 0 | 15 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |