Trial Outcomes & Findings for Incentives, Cognitive Training and Internet Therapy for Teens With Poorly Controlled Type 1 Diabetes (NCT NCT01722643)

Last Updated: 2018-06-06

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

61 participants

Primary outcome timeframe

12 months following enrollment

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	30	31
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 12 months following enrollment

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

Outcome measures

Outcome measures
Measure	MAxIM n=30 Participants 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.	Usual Care n=30 Participants 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.
HbA1c at 12 Months	8.73 percentage glycated hemoglobin Standard Error 0.18	9.29 percentage glycated hemoglobin Standard Error 0.18

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MAxIM n=29 Participants 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.	Usual Care n=29 Participants 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.
Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment	4.75 readings per day Standard Error .33	3.56 readings per day Standard Error .33

Adverse Events

MAxIM

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Usual Care

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MAxIM n=30 participants at risk 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.	Usual Care n=31 participants at risk 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.
Endocrine disorders ER visit with or without hospitalization for low blood sugar	0.00% 0/30 • 12 months Adverse events were collected at each assessment through 12 months via the Health Services Utilization form (Huang, E. S., O'Grady, M., Basu, A., Winn, A., John, P., Lee, J., ... \& Wysocki, T. (2010). The cost-effectiveness of continuous glucose monitoring in type 1 diabetes. Diabetes care, 33(6), 1269-1274.)	6.5% 2/31 • Number of events 3 • 12 months Adverse events were collected at each assessment through 12 months via the Health Services Utilization form (Huang, E. S., O'Grady, M., Basu, A., Winn, A., John, P., Lee, J., ... \& Wysocki, T. (2010). The cost-effectiveness of continuous glucose monitoring in type 1 diabetes. Diabetes care, 33(6), 1269-1274.)
Endocrine disorders ER visit with or without hospitalization for high blood sugar	3.3% 1/30 • Number of events 1 • 12 months Adverse events were collected at each assessment through 12 months via the Health Services Utilization form (Huang, E. S., O'Grady, M., Basu, A., Winn, A., John, P., Lee, J., ... \& Wysocki, T. (2010). The cost-effectiveness of continuous glucose monitoring in type 1 diabetes. Diabetes care, 33(6), 1269-1274.)	6.5% 2/31 • Number of events 5 • 12 months Adverse events were collected at each assessment through 12 months via the Health Services Utilization form (Huang, E. S., O'Grady, M., Basu, A., Winn, A., John, P., Lee, J., ... \& Wysocki, T. (2010). The cost-effectiveness of continuous glucose monitoring in type 1 diabetes. Diabetes care, 33(6), 1269-1274.)

Other adverse events

Other adverse events
Measure	MAxIM n=30 participants at risk 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.	Usual Care n=31 participants at risk 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.
Endocrine disorders Severe low blood sugar event requiring assistance to treat	3.3% 1/30 • Number of events 28 • 12 months Adverse events were collected at each assessment through 12 months via the Health Services Utilization form (Huang, E. S., O'Grady, M., Basu, A., Winn, A., John, P., Lee, J., ... \& Wysocki, T. (2010). The cost-effectiveness of continuous glucose monitoring in type 1 diabetes. Diabetes care, 33(6), 1269-1274.)	3.2% 1/31 • Number of events 1 • 12 months Adverse events were collected at each assessment through 12 months via the Health Services Utilization form (Huang, E. S., O'Grady, M., Basu, A., Winn, A., John, P., Lee, J., ... \& Wysocki, T. (2010). The cost-effectiveness of continuous glucose monitoring in type 1 diabetes. Diabetes care, 33(6), 1269-1274.)

Additional Information

Dr. Catherine Stanger

Dartmouth-Hitchcock

Phone: 603-646-7023

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	MAxIM n=30 Participants 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.	Usual Care n=31 Participants 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.	Total n=61 Participants Total of all reporting groups
Age, Continuous	15.2 years STANDARD_DEVIATION 1.4 • n=5 Participants	14.9 years STANDARD_DEVIATION 1.5 • n=7 Participants	15.1 years STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	31 participants n=7 Participants	61 participants n=5 Participants
HbA1c	9.1 percentage glycated hemoglobin STANDARD_DEVIATION 1.0 • n=5 Participants	9.2 percentage glycated hemoglobin STANDARD_DEVIATION 0.9 • n=7 Participants	9.1 percentage glycated hemoglobin STANDARD_DEVIATION 0.9 • n=5 Participants