Assessment of an iPhone Application on Glycemic Control in Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Assessment of an Electronic Self-Management Tool on Glycemic Control in Teens With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899274
• Other study ID #: 1000036524
• Secondary ID: 11054
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: April 18, 2016
• Start date: July 2013
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess whether an electronic self-management tool, specifically an iPhone application entitled bant, can improve glycemic control in Adolescents who have Type 1 Diabetes Mellitus (T1DM).

Description:

Type 1 Diabetes Mellitus (T1DM) is among the most common chronic diseases affecting children, adolescents and adults. While intensive patient self-management can optimize Blood Glucose (BG) to near-normal levels, it is a challenge for many TIDM patients to continuously achieve this. These difficulties are compounded in the adolescent population, who struggle with daily self-management and therefore may increase their risk of T1DM complications.

Due to this observation an electronic self-management tool, in the form of an iPhone application called bant, was developed. This app guides the analysis of BG data and suggests changes in treatment, while also using social network and rewards to encourage and reinforce self-care behaviors, such as frequent self-monitoring of blood glucose levels (SMBG). By primarily measuring changes in HbA1C levels, the study will assess if bant and its features are associated with improved glycemic control in the adolescents who use it.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 16 Years

Eligibility

Inclusion Criteria:

• T1DM as defined by 2008 Canadian Diabetes Association (CDA,2008)guidelines, with duration = 1 year

• Age 11-16 years, inclusive at enrollment in the trial

• 2 of the participant's last 3 A1C results prior to enrollment, including the most recent, falling between 8.0% - 10.5%

• Have been followed for at least 6 months in the current diabetes clinic

Exclusion Criteria:

• Non-English speaking adolescents as the version of bant being used in the randomized control trial (RCT) is only offered in English at this time.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• bant iPhone application

Locations

Country	Name	City	State
Canada	Trillium Health Partners	Mississauga	Ontario
Canada	The Hostpital for Sick Children	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Thrasher Research Fund, University Health Network, Toronto, York University

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Cafazzo JA, Casselman M, Hamming N, Katzman DK, Palmert MR. Design of an mHealth app for the self-management of adolescent type 1 diabetes: a pilot study. J Med Internet Res. 2012 May 8;14(3):e70. doi: 10.2196/jmir.2058. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Hemoglobin A1C levels	Hemoglobin A1C levels are a common and important measure of diabetes control, and will be collected at baseline, regular 3-month research follow-ups, a final 12-month research visit. Primary Outcome will be based on comparison of A1C values at baseline to A1C values at RCT completion (12 months).; In order to assess the potential durability of the intervention, A1C values will also be recorded (from clinical visits) 6-months and 12-months post-RCT completion.	12 month RCT duration	No
Secondary	Hypoglycemic Events	Hypoglycemic events will be measured at baseline, and every following 3 months (for 1 year). These will include both severe hypoglycemic events (requiring assistance of another individual with a BG <2.8 mmol/l and/or reversal of symptoms with oral or intravenous carbohydrate/glucose) and mild hypoglycemic events (BG <3.4mmol/L).	12 month RCT duration	No
Secondary	Self-Efficacy	Participant Self-Efficacy will be measured using verified survey and questionnaire tools. Data will be collected at baseline and every following 3 months (for 1 year).	12 month RCT duration	No
Secondary	Self-Care Behaviour	Self-Care Behaviour will be measured using verified survey and questionnaire tools. Data will be collected at baseline and every following 3 months (for 1 year).	12 month RCT duration	No
Secondary	Treatment Adherence	Participant Treatment Adherence will be measured using verified survey and questionnaire tools. Data will be collected at baseline and every following 3 months (for 1 year).	12 month RCT duration	No
Secondary	Quality of Life	Participant Quality of Life will be measured using verified survey and questionnaire tools. Data will be collected at baseline and every following 3 months (for 1 year).	12 month RCT duration	No
Secondary	bant Component Usage	Usage rates of various bant components, such as social networking and rewards, will be monitored and correlated with changes in primary and secondary outcome measures.	12 month RCT duration	No