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Incentives, Cognitive Training and Internet Therapy for Teens With Poorly Controlled Type 1 Diabetes

Incentives, Cognitive Training and Internet Therapy for Teens With Poorly Controlled Type 1 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01722643
Enrollment
61
Registered
2012-11-07
Start date
2014-01-31
Completion date
2016-09-30
Last updated
2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Brief summary

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.

Detailed description

Type 1 diabetes in adolescents is a significant medical condition associated with high economic costs and increased mortality, and its incidence is increasing. Unfortunately, adolescents show poorer adherence to self monitoring of blood glucose (SMBG) recommendations and poorer metabolic control than adults. Although some individual and family-based interventions have shown promise in improving metabolic control, there is a critical need to develop more effective interventions. The overall goal of this DP3 project is to develop a new innovative intervention that targets decision making to help teens with poor diabetic metabolic control increase the frequency of SMBG and improve HbA1c. The target population will be teens aged 13-17 with type 1 diabetes and HbA1c \>8%. Based on our prior work and a conceptual model, the proposed study will develop and pilot test a novel, multifaceted, developmentally appropriate intervention aimed at improving adolescent decision making. An integrated set of components target adolescents' need for frequent positive feedback, improved future orientation, and motivational support. While past research indicates that behavioral interventions are frequently more successful when they include multiple elements, no previous intervention has combined multiple empirically-based components that target key decision making levers in one intervention. 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), an efficacious 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 to increase the reach of the intervention to families living distant from their treating endocrinologist. MAxIM will be teen and parent friendly and designed to increase engagement and compliance with the intervention. Primary hypotheses are that 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. The unique set of interventions holds promise for improving adherence by affecting multiple basic mechanisms that determine poor decision making. The project will develop a novel, highly transportable, home based intervention designed to maximize and sustain HbA1c reductions and SMBG frequency over time in adolescents. Innovations include the targeting of multiple levers specific to adolescent decision making, use of technology to deliver the intervention to families at home, and testing cognitive predictors of treatment outcome for teens with diabetes. Successful achievement of this study's aims will bring the field closer to a cost effective, long-lasting intervention to improve outcomes among these high-risk youth.

Interventions

BEHAVIORALMAxIM

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.

BEHAVIORALUsual 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.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HbA1c at 12 Months12 months following enrollmentGlycated 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

Secondary

MeasureTime frameDescription
Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment12 months following enrollmentParticipants 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
MAxIM
This 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.
30
Usual Care
Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive 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.
31
Total61

Baseline characteristics

CharacteristicMAxIMUsual CareTotal
Age, Continuous15.2 years
STANDARD_DEVIATION 1.4
14.9 years
STANDARD_DEVIATION 1.5
15.1 years
STANDARD_DEVIATION 1.4
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
29 Participants31 Participants60 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
HbA1c9.1 percentage glycated hemoglobin
STANDARD_DEVIATION 1
9.2 percentage glycated hemoglobin
STANDARD_DEVIATION 0.9
9.1 percentage glycated hemoglobin
STANDARD_DEVIATION 0.9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
30 Participants30 Participants60 Participants
Region of Enrollment
United States
30 participants31 participants61 participants
Sex: Female, Male
Female
11 Participants15 Participants26 Participants
Sex: Female, Male
Male
19 Participants16 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 31
other
Total, other adverse events
1 / 301 / 31
serious
Total, serious adverse events
1 / 303 / 31

Outcome results

Primary

HbA1c at 12 Months

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

Time frame: 12 months following enrollment

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
MAxIMHbA1c at 12 Months8.73 percentage glycated hemoglobinStandard Error 0.18
Usual CareHbA1c at 12 Months9.29 percentage glycated hemoglobinStandard Error 0.18
Secondary

Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment

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.

Time frame: 12 months following enrollment

Population: 1 participant in the MaxIM arm and 1 participant in the Usual Care arm did not provide meter data at 12 months so do not have data for this outcome.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
MAxIMDaily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment4.75 readings per dayStandard Error 0.33
Usual CareDaily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment3.56 readings per dayStandard Error 0.33

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026