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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D)

NCT03263494

Type 1 Diabetes Mellitus

COMPLETED PHASE3

Assessment of a Decision Support Tool in Participants With Type 1 Diabetes

NCT04428645

Type 1 Diabetes

COMPLETED NA

A Novel Carbohydrate Counting Smartphone App for Youth With Type 1 Diabetes

NCT04354142

Diabetes Mellitus, Type 1

COMPLETED NA

Assessing the Impact of Control-IQ Technology

NCT04838561

Type 1 Diabetes

COMPLETED

Tandem Control-IQ Evaluation Regarding Glucose Metrics, Sleep, and Health Economics

NCT05969106

Type 1 Diabetes

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

bant iPhone application

Intervention Type DEVICE

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bant iPhone application

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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