NCT01722643

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 19, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 6, 2018

Completed
Last Updated

June 6, 2018

Status Verified

May 1, 2018

Enrollment Period

2.7 years

First QC Date

October 19, 2012

Results QC Date

April 4, 2018

Last Update Submit

May 4, 2018

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months following enrollment

Secondary Outcomes (1)

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

    12 months following enrollment

Study Arms (2)

MAxIM

EXPERIMENTAL

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.

Behavioral: MAxIM

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

Interventions

MAxIMBEHAVIORAL

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.

MAxIM
Usual CareBEHAVIORAL

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.

Usual Care

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy/breast feeding
  • Active psychosis
  • Severe medical or psychiatric illness that will limit participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth College

Hanover, New Hampshire, 03755, United States

Location

Related Publications (2)

  • 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.

    PMID: 32508201DERIVED

  • 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.

    PMID: 30418521DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Catherine Stanger
Organization
Dartmouth-Hitchcock
catherine.stanger@dartmouth.edu
603-646-7023

Study Officials

  • Catherine Stanger, PhD

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 19, 2012

First Posted

November 7, 2012

Study Start

January 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

June 6, 2018

Results First Posted

June 6, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)