Model Driven Diabetes Care

Diabetes Mellitus, Type 1 Clinical Trial

— MDDC  

Official title:

Data Driven Feedback as a Method to Improve Glycaemic Control in Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774149
• Other study ID #: 2011/1939 (REK)
• Status: Completed
• Phase: N/A
• First received: January 11, 2013
• Last updated: August 17, 2015
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2015
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics CommiteeNorway: Data Protection Authority
• Study type: Interventional

Clinical 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.

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].

1. Skrøvseth SO et al, Diabetes Technol Ther (2012)

2. Skrøvseth SO et al, PLoS ONE (2012)

3. Skrøvseth SO et al, Accepted for Advanced Technologies and Treatments for Diabetes, Paris, France, 2013.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Severe complications due to their diabetes.

• Unable to understand or conform to the guidelines when presented with the phone's software.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Norway	University Hopital of North Norway	Tromsø

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital of North Norway	The Research Council of Norway, University of Tromso

Country where clinical trial is conducted

Norway, 

References & Publications (5)

Årsand E, Frøisland DH, Skrøvseth 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. Review. — View Citation

Skrøvseth SO, Årsand 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. — View Citation

Skrøvseth 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. — View Citation

Skrøvseth SO, Årsand 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. — View Citation

Skrøvseth 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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.	Up to 12 weeks post-enrollment.	No
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.	Up to 12 weeks post-enrollment	No
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).	up to 20 weeks post-enrollment	No