- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01722643
Incentives, Cognitive Training and Internet Therapy for Teens With Poorly Controlled Type 1 Diabetes
The overall goal of this project is to develop a novel family friendly intervention that will help teens with poor metabolic control of their type 1 diabetes increase and sustain daily self monitoring of blood glucose and lower HbA1c. This is important because poor metabolic control has long-term health implications. This project will provide important information regarding new effective ways to improve outcomes among teens with poorly controlled type 1 diabetes.
Primary hypotheses are that the intervention, MAxIM, will: (1) help teens improve and maintain glucose control, and (2) improve decision making (improve executive function and reduce delay discounting), which will predict treatment outcome.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Hampshire
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Hanover, New Hampshire, United States, 03755
- Dartmouth College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 13-17 years old
- Diagnosis of type 1 diabetes
- Average HbA1c > or = to 8% for the past 6 months (mean of two values)
- Most recent HbA1c is > or = to 8%
- Duration of disease is > 18 months
- Teen must live at home
- Family must have broadband internet in the home
Exclusion Criteria:
- Pregnancy/breast feeding
- Active psychosis
- Severe medical or psychiatric illness that will limit participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MAxIM
This new intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation.
The interventions will be delivered to families at home via the internet.
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This new intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation.
The interventions will be delivered to families at home via the internet.
|
Active Comparator: Usual Care
Usual Care reflects the standard treatment currently provided at the Children's Hospital at Dartmouth.
Teens will be followed by their treating endocrinologist and receive the following standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.
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Usual Care reflects the standard treatment currently provided at the Children's Hospital at Dartmouth.
Teens will be followed by their treating endocrinologist and receive the following standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c at 12 Months
Time Frame: 12 months following enrollment
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Glycated hemoglobin test (HbA1c) measures the non-enzymatic glycation status of hemoglobin expressed in percentage points.
Analyses control for pump status, diabetes duration and baseline HbA1c
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12 months following enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment
Time Frame: 12 months following enrollment
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Participants will use a glucometer to self-monitor blood glucose daily.
Readings from the glucometer will be uploaded at each session and at the follow up visits.
The glucometer records the blood glucose level as well as a date/time stamp over a 90 day period.
To assess the daily testing frequency, the total number of blood glucose tests a day during the 14 days prior to each assessment will be recorded from the study provided glucometer.
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12 months following enrollment
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Catherine Stanger, PhD, Dartmouth College
Publications and helpful links
General Publications
- Crochiere RJ, Hughes Lansing A, Carracher A, Vaid E, Stanger C. Attentional bias to diabetes cues mediates disease management improvements in a pilot randomized controlled trial for adolescents with type 1 diabetes. J Health Psychol. 2021 Dec;26(14):2699-2710. doi: 10.1177/1359105320926535. Epub 2020 Jun 7.
- Stanger C, Lansing AH, Scherer E, Budney A, Christiano AS, Casella SJ. A Web-Delivered Multicomponent Intervention for Adolescents with Poorly Controlled Type 1 Diabetes: A Pilot Randomized Controlled Trial. Ann Behav Med. 2018 Nov 12;52(12):1010-1022. doi: 10.1093/abm/kay005.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23559
- 1DP3HD076602-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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