Diabetes Mellitus, Type 1
Conditions
Keywords
Continuous Glucose Monitoring, Insulin Pump, Hybrid Closed Loop Systems, Diabetes Technology, Health Disparities
Brief summary
Diabetes technology has revolutionized T1D management, disparities in technology access are evident among racial-ethnic minorities, patients with lower socioeconomic status and those with poorly controlled T1D (A1c\>8.5%). In order to examine whether diabetes technology can reduce diabetes care burdens and enhance outcomes among some of highest need patients, diabetes technology clinical trials must be expanded beyond the very select populations included in studies thus far (ie., mostly White, higher SES). Therefore, the investigators propose to perform a pilot RCT of hybrid closed-loop insulin pump therapy (HCL) in 40 diverse adult patients with poorly controlled T1D (HbA1c \>8.5%) from the largest academic and safety net health systems in the Los Angeles region to determine the feasibility of a RCT in this population and identify facilitators and barriers of effective use of closed loop insulin pump therapy in patients with poorly controlled T1D.
Interventions
DEVICEHybrid Closed Loop Insulin Pump System
Patients will be started on an automated insulin delivery system.
Sponsors
University of California, Los Angeles
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Olive View-UCLA Education & Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 Diabetes * A1c \>8.5% * Not insulin pump user * Primary language of English or Spanish * Have medical insurance coverage
Exclusion criteria
* No measured A1c in the past year * Have comorbidities that can result in inaccurate hemoglobin A1c * Have cognitive, physical or mental impairment precluding diabetes technology use * Limited life expectancy (\<1 year) * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of screened participants that are eligible | 6 months | Eligible among screened, enrolled among eligible, excluded among screened (and why) based on screening, recruitment and enrollment data. |
| Proportion of enrolled participants that are randomized | 6 months | Randomized among enrolled, and receiving allocated intervention among randomized. |
| Proportion of average time delay to enrollment | 6 months | Average time delay from screening to enrollment. |
| Proportion of retention among participants randomized to the Intervention Group | 6 months | Retention among participants receiving allocated intervention after being randomized and discontinued intervention among randomized. |
| Proportion of retention among participants randomized | 6 months | Participants lost to follow-up among those initially randomized. |
| Number of participants who adhere to assigned treatment | 6 months | Treatment-specific adherence, Adherence to study protocol and Proportion of planned assessments that are completed. Fidelity, which pertains to guaranteeing that the intervention is delivered in accordance with the established protocol, will be summarized by study arms, and differences between arms will be examined using t-tests or two-sample tests of proportions as appropriate. Adherence, which relates to the extent to which participants follow the treatment and study protocol, as well as the proportion of planned assessments completed, will be summarized by study arms, and differences between arms will be examined using t-tests or two-sample tests of proportions as appropriate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1c | 6 months | Serum Hemoglobin A1c laboratory measurement |
| Episodes and % of time with severe hypoglycemia ( BG <54 mg/dl) | 6 months | Hypoglycemia will be measure by combining CGM metrics and glucometer to report severe hypoglycemia in mg/dl. |
| Mean Diabetes Ketoacidosis Episodes Incidence | 6 months | Assess instances of diabetic ketoacidosis through participant surveys and comprehensive chart reviews. |
| ED visits/Hospitalizations Number of diabetes related ED visits or hospitalizations | 6 months | Number of diabetes related ED visits or hospitalizations |
| Treatment Burden and Satisfaction: Diabetes Distress | 6 months | Assessing treatment burden through the Type 1 Diabetes Distress Assessment System T1DDAS, which comprises eight questions and evaluates ten prevalent sources of diabetes distress in adults with type 1 diabetes. The score indicates the level of diabetes distress reported by the respondent, with higher scores indicating greater intensity. The core scale scoring ranges 1 to 5. This scale assesses each of ten common Sources of diabetes distress for adults with type 1 diabetes: Financial Worries, Interpersonal Challenges, Management Difficulties, Shame, Hypoglycemia Concerns, Healthcare Quality, Lack Of Diabetes Resources, Technology Challenges, Burden To Others, Worries About Complications. The higher the score, the more impactful that Source is likely to be in contributing to diabetes distress for this individual with the minimum value being 1 and maximum value being 5. |
| Treatment Burden and Satisfaction: Insulin Treatment Satisfaction | 6 months | Assessed treatment burden and satisfaction using the Insulin Treatment Satisfaction Questionnaire (ITSQ), consisting of 22 questions among 5 content clusters with a score from 0 to 100% where a higher score indicates greater satisfaction with insulin treatment. The scale explores perceptions of current insulin treatment and its impact on daily life. |
| Treatment Burden and Satisfaction: Glucose Monitoring System Satisfaction (GMSS) | 6 months | Examined treatment burden and satisfaction employing the Glucose Monitoring System Satisfaction Survey (GMSS), comprising 15 questions divided into four subcategories: openness, emotional burden, behavioral burden and trust. Higher scores within each subcategory denote either greater satisfaction or burden, depending on the specific aspect assessed with the minimum value being 1 and maximum value being 5. The total scare has a minimum value of 1 and maximum value of 15 with higher scores indicating greater satisfaction. The scores are obtained by calculating the mean for each. |
| Treatment Burden and Satisfaction: Motivation and Attitudes Towards Changing Health (MATCH) | 6 months | Assessed treatment burden and satisfaction using the Motivation and Attitudes towards Health Scale (MATCH), consisting of nine questions categorized into four subgroups: willingness to make changes, perceived ability to make or maintain changes, feeling changes are worthwhile, and overall mean/average of willingness, able, and worthwhile. Scores are calculated by determining the mean or average response within each category with higher scores meaning a better outcome. WILLINGNESS: minimum value is 1 and maximum value is 5. ABLE: minimum value is 1 and maximum value is 5. WORTHWHILE: minimum value is 1 and maximum value is 5. TOTAL SCALE: minimum value is 1 and maximum value is 9. |
Countries
United States
Contacts
CONTACTEstelle M Everett, MD, MHS
Outcome results
None listed