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Completed

NCT Number: NCT01899274

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

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).

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trillium Health Partners, Mississauga, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bant iPhone application

Device

Primary outcomes

  1. Changes in Hemoglobin A1C levels

    Time frame: 12 month RCT duration

    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 outcomes

  1. Hypoglycemic Events

    Time frame: 12 month RCT duration

    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).

  2. Self-Efficacy

    Time frame: 12 month RCT duration

    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).

  3. Self-Care Behaviour

    Time frame: 12 month RCT duration

    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).

  4. Treatment Adherence

    Time frame: 12 month RCT duration

    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).

  5. Quality of Life

    Time frame: 12 month RCT duration

    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).

  6. bant Component Usage

    Time frame: 12 month RCT duration

    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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Thrasher Research Fund
  • University Health Network, Toronto
  • York University

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 15, 2013
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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