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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by The Hospital for Sick Children
Sponsor:
Collaborators:
Thrasher Research Fund
University Health Network, Toronto
York University
Information provided by (Responsible Party):
Mark Palmert, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01899274
First received: July 10, 2013
Last updated: October 9, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention
Diabetes Mellitus, Type 1
Device: bant iPhone application

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of an Electronic Self-Management Tool on Glycemic Control in Teens With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Changes in Hemoglobin A1C levels [ Time Frame: 12 month RCT duration ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Hypoglycemic Events [ Time Frame: 12 month RCT duration ] [ Designated as safety issue: No ]
    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).

  • Self-Efficacy [ Time Frame: 12 month RCT duration ] [ Designated as safety issue: No ]
    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).

  • Self-Care Behaviour [ Time Frame: 12 month RCT duration ] [ Designated as safety issue: No ]
    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).

  • Treatment Adherence [ Time Frame: 12 month RCT duration ] [ Designated as safety issue: No ]
    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).

  • Quality of Life [ Time Frame: 12 month RCT duration ] [ Designated as safety issue: No ]
    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).

  • bant Component Usage [ Time Frame: 12 month RCT duration ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 92
Study Start Date: July 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bant Group
Subjects in the bant Group will receive care as usual, as well as an iPhone loaded with the bant iPhone application and a bluetooth enabled glucometer. Participants will have their A1C levels measured every 3 months (for 1 year), and also complete questionnaires/interviews relating to their diabetes management and lifestyle.
Device: bant iPhone application
No Intervention: Control Group
Subjects in the control group will continue care as usual with their diabetes team, without supplementation of the bant application. Participants will have their A1C levels measured every 3 months (for 1 year), as well as complete questionnaires/interviews relating to their diabetes management and lifestyle.

Detailed 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.

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899274

Contacts
Contact: Mark R Palmert, M.D., Ph.D 416-813-6217 ext 206217 mark.palmert@sickkids.ca

Locations
Canada, Ontario
Trillium Health Partners Recruiting
Mississauga, Ontario, Canada, L5B 1B8
Contact: Sally Reiser    905-848-7580 ext 3419    sally.reiser@trilliumhealthpartners.ca   
Principal Investigator: Angelo Simone, M.D.         
The Hostpital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Caitlin A Nunn, M.Sc.    416-813-7654 ext 328158    caitlin.nunn@sickkids.ca   
Contact: Stephanie So, MPH    416-340-4800 ext 6843    Stephanie.So@uhn.ca   
Principal Investigator: Mark R Palmert, M.D., Ph.D.         
Sub-Investigator: Joesph Cafazzo, Ph.D., P.Eng         
Sub-Investigator: Debra Katzman, M.D.         
Sub-Investigator: Harvey Skinner, Ph.D., C.Pysch         
Sub-Investigator: Michael Rotondi, Ph.D.         
Sponsors and Collaborators
The Hospital for Sick Children
Thrasher Research Fund
University Health Network, Toronto
York University
Investigators
Principal Investigator: Mark R Palmert, M.D., Ph.D. The Hospital for Sick Children
  More Information

Publications:
Caffazo, J.A., Casselman, M., Hamming, N., Katzman, D.K, Palmert, M.R. Design of an mHealth App for the Self-Management of Adolescent Type 1 Diabetes: A Pilot Study. Journal of Medical Internet Research 14(3):e70, 2012.

Responsible Party: Mark Palmert, Head of Division of Endocrinology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01899274     History of Changes
Other Study ID Numbers: 1000036524, 11054
Study First Received: July 10, 2013
Last Updated: October 9, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014