Type 1 DiabetesPump It Up!NCT02333539
Adherence Intervention to Promote Optimal Use of Insulin Pumps in Adolescents With Type 1 Diabetes
A study testing Adherence behaviors and recommendations for improvement. and Adherence behavior that needs improvement is targeted in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Adherence behaviors and recommendations for improvement. and Adherence behavior that needs improvement is targeted
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 20 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ages 10-17 years
- type 1 diabetes diagnosis at least 1 year
- use insulin pump
Who cannot join
- developmental delay
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Adherence Intervention to Promote Optimal Use of Insulin Pumps in Adolescents
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Adherence behaviors and recommendations for improvement., Adherence behavior that needs improvement is targeted
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence behaviors and recommendations for improvement.Behavioural
Adherence behavior that needs improvement is targetedBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Tailored feedback | Experimental | Participants are provided a Tailored Feedback report based on data downloaded from their insulin pumps. Summaries are provided about insulin pump adherence behaviors and recommendations for improvement are made. Receives: Behavioral: Adherence behaviors and recommendations for improvement. |
| Problem Solving | Experimental | Participants receive a problem-solving session based on data downloaded from their insulin pumps. An insulin pump adherence behavior that needs improvement is targeted; goals are set and solutions generated. Receives: Behavioral: Adherence behavior that needs improvement is targeted |
| Treatment as Usual | No intervention | Standard of care as provided by the endocrinologist occurs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Insulin Pump Adherence Behaviors
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.
Measured: every 3 months up to 12 months
Secondary outcomes (1)
Change in Glycemic Control (A1C)
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%.
Measured: every 3 months up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startSep 2012
- Primary completion20 Aug 2018
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly A Driscoll, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333539
- Sponsor's protocol ID
- 15-0965
- Acronym
- Pump It Up!
- Status last verified
- Jul 2021
- First submitted
- 5 Jan 2015
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence Intervention to Promote Optimal Use of Insulin Pumps in Adolescents
- ClinicalTrials.gov ID
- NCT02333539
- Acronym / sponsor ID
- Pump It Up! / 15-0965
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tailored feedback | Experimental | Behavioral: Adherence behaviors and recommendations for improvement.Participants are provided a Tailored Feedback report based on data downloaded from their insulin pumps. Summaries are provided about insulin pump adherence behaviors and recommendations for improvement are made. |
| Problem Solving | Experimental | Behavioral: Adherence behavior that needs improvement is targetedParticipants receive a problem-solving session based on data downloaded from their insulin pumps. An insulin pump adherence behavior that needs improvement is targeted; goals are set and solutions generated. |
| Treatment as Usual | No intervention | –Standard of care as provided by the endocrinologist occurs. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ages 10-17 years
- type 1 diabetes diagnosis at least 1 year
- use insulin pump
Key exclusion criteria (1 listed)
- developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adherence behaviors and recommendations for improvement. | Behavioural | Tailored feedback |
| Adherence behavior that needs improvement is targeted | Behavioural | Problem Solving |
Primary outcome
Frequency of Insulin Pump Adherence Behaviors
Time frame: 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.
1 secondary outcome
Change in Glycemic Control (A1C)
Time frame: every 3 months up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly A Driscoll, Ph.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence behaviors and recommendations for improvement. and Adherence behavior that needs improvement is targeted in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Insulin Pump Adherence Behaviors (time frame: every 3 months up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.