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Diabetes Mellitus, Type 1NCT01899274

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

A study testing bant iPhone application in people with Diabetes Mellitus, Type 1, run by The Hospital for Sick Children at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 11 to 16 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
bant iPhone application
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
2 sitesCanada
Study dates
Jul 2013to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Trillium Health Partners

    Mississauga, Ontario, L5B 1B8

  • The Hostpital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

Official title: Assessment of an Electronic Self-Management Tool on Glycemic Control in Teens With 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).

Read the 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.

Being tested
bant iPhone application
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bant iPhone applicationDevice

Study groups in NCT01899274
Study groupRoleWhat they receive
bant GroupExperimentalSubjects 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.
Receives: Device: bant iPhone application
Control GroupNo interventionSubjects 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 month RCT duration

Secondary outcomes (6)

  1. 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).

    Measured: 12 month RCT duration

  2. 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).

    Measured: 12 month RCT duration

  3. 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).

    Measured: 12 month RCT duration

  4. 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).

    Measured: 12 month RCT duration

  5. 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).

    Measured: 12 month RCT duration

  6. 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.

    Measured: 12 month RCT duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01899274
Sponsor's protocol ID
1000036524
Other IDs
11054
Status last verified
Apr 2016
First submitted
10 Jul 2013
Last updated
19 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22564332

  • Goyal S, Nunn CA, Rotondi M, Couperthwaite AB, Reiser S, Simone A, Katzman DK, Cafazzo JA, Palmert MR. A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Jun 19;5(6):e82. doi: 10.2196/mhealth.7336.

    PubMed 28630037

Questions about this trial

What is this clinical trial studying?

A study testing bant iPhone application in people with Diabetes Mellitus, Type 1, run by The Hospital for Sick Children at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Hemoglobin A1C levels (time frame: 12 month RCT duration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01899274, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.

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