NCT01899274

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

July 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

2.5 years

First QC Date

July 10, 2013

Last Update Submit

April 18, 2016

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (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.

    12 month RCT duration

Secondary Outcomes (6)

  • Hypoglycemic Events

    12 month RCT duration

  • Self-Efficacy

    12 month RCT duration

  • Self-Care Behaviour

    12 month RCT duration

  • Treatment Adherence

    12 month RCT duration

  • Quality of Life

    12 month RCT duration

  • +1 more secondary outcomes

Study Arms (2)

bant Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

bant iPhone applicationDEVICE
bant Group

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Trillium Health Partners

Mississauga, Ontario, L5B 1B8, Canada

Location

The Hostpital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (2)

  • 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.

    PMID: 22564332RESULT

  • 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.

    PMID: 28630037DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mark R Palmert, M.D., Ph.D.

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Division of Endocrinology

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 15, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

CA(2)