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DiabetesPhase 3NCT02568501

Behavioral Economic Incentives to Improve Glycemic Control Among Adolescents and Young Adults

A Phase 3 study testing Daily feedback and Financial incentive in people with Diabetes and Type 1 Diabetes, run by University of Pennsylvania at 1 site in United States.

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

In this study the investigators will compare a novel approach using daily financial incentives and a tiered sponsor network to motivate adolescents and young adults with type 1 diabetes to improve glycemic control. Read more about this study

Who is it for?
Ages 14 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes, Type 1 Diabetes
What is being tested?
Daily feedback and Financial incentive
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
Jan 2016to Nov 2016
Phase
Phase 3
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 14 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Diagnosis of type 1 diabetes
  • HbA1c of 8 or greater
  • Receiving care from the Childrens Hospital of Philadelphia Diabetes Center
  • English-speaking
  • Owns a smartphone

Who cannot join

  • New diagnosis of type 1 diabetes within past year
  • Unable to provide informed consent
  • Already participating in another study to improve glycemic control
  • Any medical conditions that would prevent completion of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

In this study the investigators will compare a novel approach using daily financial incentives and a tiered sponsor network to motivate adolescents and young adults with type 1 diabetes to improve glycemic control.

Read the detailed description

Participants will be given daily glucose monitoring goals of ≥4 glucose checks per day with ≥1 readings within goal range (70-180 mg/dL) and provided with iHealth wireless glucometers. Half of the study participants will be randomized to the 3-month intervention arm on Way to Health. The intervention includes daily financial incentives ($60 in an account at beginning of each month with $2 daily loss if non-adherent) and a 2-level tiered sponsor network (youth select 2 people who will be notified of non-adherence after 2 and 5 consecutive days). The primary outcome will be HbA1c at 3 months compared to baseline. Secondary outcomes will include HbA1c at 6 months and the proportion of participants adherent to daily glucose monitoring goals. Exit interviews will elicit intervention feasibility and feedback from a youth perspective.

Being tested
Daily feedback, Financial incentive
Keywords
diabetes, adolescent, young adult, behavioral economics, financial incentives, social incentives
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1

What participants receive

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

  • Daily feedbackBehavioural

    Daily feedback on glucose levels from wireless glucometers

  • Financial incentiveBehavioural

    Participant receive a $2 daily financial incentive framed as a loss with money allocated upfront and taken away each day of non-adherence to goal

Study groups in NCT02568501
Study groupRoleWhat they receive
Daily feedbackExperimentalParticipants receive daily feedback from wireless glucometers that transmit data on glucose monitoring adherence.
Receives: Behavioral: Daily feedback
Daily Feedback, incentivesExperimentalParticipants receive daily feedback from wireless glucometers that transmit data on glucose monitoring adherence. Participants are eligible for a financial incentive if adherent.
Receives: Behavioral: Daily feedback; Behavioral: Financial incentive

What is being measured

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

  1. Change in HbA1c by 3 months

    Change in HbA1c from baseline to 3 months

    Measured: 3 months

Secondary outcomes (3)

  1. Change in HbA1c by 6 months

    Change in HbA1c from baseline to 6 months

    Measured: 6 months

  2. Glucose Monitoring Adherence by 3 months

    Proportion of time adherence to glucose monitoring during 3 month intervention

    Measured: 3 months

  3. Glucose Monitoring Adherence by 6 months

    Proportion of time adherence to glucose monitoring during 3 month follow-up period

    Measured: 6 months

Timeline

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

  1. First posted6 Oct 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionAug 2016
  4. Study completionNov 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02568501
Sponsor's protocol ID
15-012160
Status last verified
Nov 2016
First submitted
2 Oct 2015
Last updated
11 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • Wong CA, Miller VA, Murphy K, Small D, Ford CA, Willi SM, Feingold J, Morris A, Ha YP, Zhu J, Wang W, Patel MS. Effect of Financial Incentives on Glucose Monitoring Adherence and Glycemic Control Among Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA Pediatr. 2017 Dec 1;171(12):1176-1183. doi: 10.1001/jamapediatrics.2017.3233.

    PubMed 29059263

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daily feedback and Financial incentive in people with Diabetes and Type 1 Diabetes, run by University of Pennsylvania at 1 site in United States.

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 5 inclusion and 4 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 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in HbA1c by 3 months (time frame: 3 months). 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 NCT02568501, which also lists 1 linked publication.

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 11 Nov 2016.

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