Type 1 Diabetes
Conditions
Brief summary
The overall objective of this study is to address the critical need of improving insulin pump adherence in adolescents with Type 1 Diabetes (T1D) by providing personalized intervention using evidence-based techniques during routine diabetes clinic visits at point of care.
Detailed description
To achieve optimal use of the insulin pump, patients must engage in frequent Blood Glucose Monitoring (BGM) and insulin bolusing, and have an understanding of their relationship. BGM must occur and then it must be followed by a decision about what to do (or not do) regarding insulin bolusing. If insulin bolusing occurs in the absence of BGM, hypoglycemia and less than ideal glycemic control can occur. Of the few insulin pump adherence studies, only very basic adherence behaviors such as BGM and insulin bolusing frequency or number of hypoglycemic events have been reported. The overall objective of this study is to address the critical need of improving insulin pump adherence in adolescents with T1D by providing personalized intervention using evidence-based techniques during routine diabetes clinic visits at point of care.
Interventions
BEHAVIORALAdherence behaviors and recommendations for improvement.
BEHAVIORALAdherence behavior that needs improvement is targeted
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* ages 10-17 years * type 1 diabetes diagnosis at least 1 year * use insulin pump
Exclusion criteria
* developmental delay
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Insulin Pump Adherence Behaviors | every 3 months up to 12 months | Frequency of blood glucose monitoring per day; frequency of carbohydrate inputs per day; frequency of insulin boluses per day; frequency of insulin boluses that follow a high (\>150 mg/dL) or very high (\>250mg/dL) blood glucose result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycemic Control (A1C) | every 3 months up to 12 months | Glycemic control (A1C) will be measured with a Siemens Healthcare Diagnostics DCA Vantage, which is National Glycohemoglobin Standardization Program certified as having documented traceability to the Diabetes Control and Complications Trial Reference Method; range 4.2-6.5%. |
Countries
United States
Outcome results
None listed