NCT01774149

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

September 16, 2015

Completed
Last Updated

September 16, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

January 11, 2013

Results QC Date

June 16, 2015

Last Update Submit

August 17, 2015

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in HbA1c

    up to 20 weeks post-enrollment

Other Outcomes (2)

  • Usability

    up to 20 weeks post-enrollment

  • Empowerment

    Up to 12 weeks post-enrollment.

Study Arms (2)

Delayed Diastat

ACTIVE COMPARATOR

Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.

Device: Few Touch ApplicationDevice: Diastat

Diastat

EXPERIMENTAL

Few Touch Application with Diastat module turned on in week 4 post-enrollment.

Device: Few Touch ApplicationDevice: Diastat

Interventions

Few Touch ApplicationDEVICE

Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.

Also known as: Diabetesdagboka
Delayed DiastatDiastat
DiastatDEVICE

Users get the Few Touch Application with Diastat module activated.

Delayed DiastatDiastat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Severe complications due to their diabetes.
  • Unable to understand or conform to the guidelines when presented with the phone's software.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hopital of North Norway

Tromsø, 9038, Norway

Location

Related Publications (6)

  • 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.

    PMID: 23035775BACKGROUND

  • 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.

    PMID: 22874353BACKGROUND

  • 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.

    PMID: 23063047BACKGROUND

  • 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.

    PMID: 23300626BACKGROUND

  • 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.

    PMID: 23672413BACKGROUND

  • 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.

    PMID: 25751133DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Dr. Stein Olav Skrøvseth
Organization
Norwegian Center for Integrated Care and Telemedicine
stein.olav.skrovseth@telemed.no
+4795805841

Study Officials

  • Stein Olav Skrøvseth, PhD

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2013

First Posted

January 23, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 16, 2015

Results First Posted

September 16, 2015

Record last verified: 2015-08

Locations

NO(1)