Evaluation of Novel Trend Arrow Adjustment Tool for Diabetes Patients Using Continuous Glucose Monitoring to Guide Insulin Bolus Adjustment (TAAT Study)

NCT02064647 | Completed DMC

• 1 other identifier: JDRF CCTN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous glucose monitoring (CGM) provides up to 288 blood glucose levels per day, updated every 5 minutes and displayed in real-time on the insulin pump, which can be used to enhance delivery of insulin through pump therapy. In addition this real-time CGM data includes "trend arrows" which indicate when the blood glucose is rapidly falling or rising thus enabling the pump user to make immediate adjustments in insulin delivery to prevent subsequent low or high blood sugars. The trend arrows are displayed when the blood glucose is rapidly falling or rising. For example, if the glucose is increasing by 1-2 mmol/L over 20 minutes, a single upward arrow alerts the pump wearer, who can then decide to give a bolus of insulin or increase the meal bolus. Should the glucose level be increasing at a rate greater than 2mmol/L over 20 minutes, 2 upward arrows are displayed and the user could decide to give a larger bolus. The purpose of the bolus adjustment is to add insulin for the predicted rise in glucose to prevent or reduce subsequent hyperglycemia. Similarly, a decrease in the insulin bolus is advised if glucose levels are falling as evidenced by one or two downward arrows. However, effective strategies for adjusting insulin boluses based on CGM trend arrows are lacking. The JDRF CGM Study Group recommended that boluses be adjusted based on trend arrows using a standard 10-20% increase/decrease of the total original recommended bolus dose (10% for one arrow up or down, and 20% for two arrows up or down), with the original bolus dose calculated by the pump calculator (i.e. Bolus Wizard). However, the original recommended bolus dose is dependent on the amount of food to be consumed (grams of carbohydrate) and the current blood glucose (if above or below target range), as well as the amount of active insulin, and therefore increasing or decreasing the total recommended bolus by 10-20% may overcompensate for the trend arrows and result in postprandial hypoglycemia. Attempts to use the10/20% formula within CHEO's large pediatric pump/CGM population resulted in low acceptance and adherence by CGM users. The CGM TIME Trial Study Group develop an innovative tool for adjusting boluses for CGM trend arrows based on the patient's own insulin sensitivity factor (ISF). The Trend Arrow Adjustment Tool formula is: if CGM shows a single arrow up or down: adjust bolus by +/- (1.5/ISF) and for 2 arrows up or down +/- (3/ISF). Use of the Trend Arrow Adjustment Tool within the CGM TIME Trial appears to lead to more appropriate adjustment in bolus dosing, and more effective prevention of subsequent hyper- and hypoglycemia. Furthermore, this tool appears to have excellent uptake amongst the TIME Trial participants, with observations that there is continued usage of the tool throughout the 12 month study, and greater satisfaction with this component of CGM. However, the tool has not been systematically evaluated. The proposed study will evaluate the Trend Arrow Adjustment Tool, to determine its effectiveness in reducing postprandial hyper- and hypoglycemia, as well as parent, child/youth satisfaction, and ease of use of the tool based on self-report measures. Comparison will be made with the 10/20% bolus adjustment \& also to no adjustments to meal boluses (i.e. ignoring CGM trend arrows). Should use of the Trend Arrow Adjustment Tool lead to more time spent within the target glucose range, this will have immediate clinical benefit for patients, including improved quality of life, and potentially a reduction in HbA1c and prevention of long-term complications.

Conditions

Diabetes Mellitus, Type 1

Keywords

Insulin Infusion Systems; Blood Glucose

Outcome Measures

Primary Outcomes (1)

• Time spent with postprandial glucose level in target range

  Glucose target level is 4-10mmol/L post meals

  during 3 week trial

Secondary Outcomes (2)

• Frequency & duration of postprandial hyperglycemia

  during 3 week study period

• Frequency & duration of postprandial hypoglycemia

  during 3 week study period

Other Outcomes (2)

• Uptake of Trend Arrow Adjustment Tool

  during 3 week study period

• Satisfaction/ease of use of Trend Arrow Adjustment Tool

  during 3 week study period

Study Arms (3)

Trend Arrow Adjustment Tool

EXPERIMENTAL

The Trend Arrow Adjustment Tool, uses a formula based on the patients Insulin Sensitivity Factor (ISF) to allow adjustments to meal time insulin boluses, based on CGM trend arrows.

Other: Trend Arrow Adjustment Tool

10/20% bolus adjustment

ACTIVE COMPARATOR

10-20% increase/decrease of the total original recommended bolus dose (10% for one arrow up or down, and 20% for two arrows up or down), with the original bolus dose calculated by the pump calculator (i.e. Bolus Wizard).

Other: 10/20% bolus adjustment

No adjustment/ignore trend arrows

NO INTERVENTION

Subjects will ignore the CGM trend arrows, meal time bolus insulin as per Bolus Wizard

Interventions

Trend Arrow Adjustment Tool OTHER

The Trend Arrow Adjustment Tool formula is: if CGM shows a single arrow up or down: adjust bolus by +/- (1.5/ISF) and for 2 arrows up or down +/- (3/ISF). Where ISF is the patients own insulin sensitivity factor.

Trend Arrow Adjustment Tool

10/20% bolus adjustment OTHER

The 10/20% bolus adjustment formula is: if CGM shows a single arrow up or down: adjust bolus by +/- 10% and for 2 arrows up or down +/- 20%.

10/20% bolus adjustment

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants will be children and youth aged 5-18 years, attending CHEO diabetes clinic
• Established Type 1 diabetes for more than 1 year,
• Who have used an insulin pump and CGM for at least 3 months.
• Willing to wear iPro2 blinded CGM and to use the Trend Arrow Adjustment Tool and the 10/20% bolus adjustment method.
• Internet access at home (to upload CGM data).

You may not qualify if:

• Conditions which may interfere with the subject's ability to participate in the study.
• Has received oral and/or intravenous steroid therapy (for any indication, at any dose and/or for any duration) on more than 2 separate occasions in the past 12 months. Use of inhaled and/or topical steroid therapy in the last 12 months does not exclude the subject

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Margaret Lawson, MD, MSc, MHSc, FRCP

  Children's Hospital of Eastern Ontario Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, Evidence to Practice Research Program, CHEO Research Institute, Pediatric Endocrinologist, CHEO, Associate Professor, Faculty of Medicine, University of Ottawa, Director, JDRF Canadian Clinical Trial Network

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 17, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

CA (1)