Diabetes Mellitus, Type 1NCT03534544
Patient and Parent Preferences for an On-Body Automated Insulin Delivery System
An observational study of Diabetes Mellitus, Type 1, run by Joslin Diabetes Center at 2 sites in United States.
Trial summary
The goal of this study is to learn more about patient and family preferences regarding use of advanced diabetes technologies. Young persons with type 1 diabetes (ages 8-25) and parents of young persons with type 1 diabetes will complete one study visit involving a semi-structured interview and surveys. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- How many people
- 362 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Aug 2018to 17 Dec 2019
- Phase
- Observational
- 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 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will be recruited from the clinic populations of the 2 study sites.
Who may be able to join
- Young persons (ages 8-25 years) with type 1 diabetes for 1 year or longer
- Parents of young persons with type 1 diabetes
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Joslin Diabetes Center
Boston, Massachusetts, 02215
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
The goal of this study is to learn more about patient and family preferences regarding use of advanced diabetes technologies. Young persons with type 1 diabetes (ages 8-25) and parents of young persons with type 1 diabetes will complete one study visit involving a semi-structured interview and surveys. The results of the study will be used to assist in the design of a new automated insulin delivery system.
Read the detailed description
Type 1 diabetes remains the most common chronic disease of childhood and affects millions of children and adults globally. The minority of persons with type 1 diabetes achieve the recommended glycemic targets. Currently approved and unapproved automated insulin delivery systems require patients to carry and wear multiple devices (pumps, tubing, blood glucose meters, mobile devices, etc.). There is a need to design automated insulin delivery systems that reduce the burden of diabetes management for young persons and their families in an effort to improve glycemic control as well as other biomedical and psychosocial outcomes.
The purpose of this study is to conduct separate semi-structured interviews with young persons with type 1 diabetes and parents of youth with type 1 diabetes (not necessarily the parents of the youth participants) regarding their preferences for an automated, on-body insulin delivery system. Youth and parents will also complete short surveys related to perceived burden of diabetes self-care, quality of life, acceptance of diabetes, and worries about hypoglycemia. The feedback received from the interviews and surveys will help inform the design of a new on-body automated insulin delivery system.
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- artificial pancreas, pediatric, parents, adherence
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth and parent preferences for automated insulin delivery systems
Semi-structured interviews with young persons with type 1 diabetes and parents; interviews will be transcribed and analyzed to derive central themes; this is a qualitative outcome
Measured: 1 day
Secondary outcomes (4)
Diabetes burden
Problem Areas in Diabetes survey - Pediatric version (PAID-Peds) and Parent revised version (PAID-PR)
- PAID-Peds: 20 items, PAID-PR: 18 items
- Possible score: 0-100
- Higher score indicates more burden
Measured: 1 day
Worries about hypoglycemia
Fear of Hypoglycemia survey - Worry Scale
- 15 items
- Possible score: 0-100
- Higher score indicates more worry about hypoglycemia
Measured: 1 day
Diabetes acceptance
Accepting Diabetes and Personal Treatment (ADAPT) survey
- 24 items
- Scoring methodology will be established with data from this study
Measured: 1 day
Quality of life
5-Item World Health Organization (WHO-5) Well-Being Index
- 5 items
- Possible score: 0-100 (percentage score)
- Higher score indicates better quality of life
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start23 Aug 2018
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Laffel, Joslin Diabetes Center
- Investigators
- Lori Laffel, MD, MPH, Principal investigator, Joslin Diabetes CenterStuart Weinzimer, MD, Principal investigator, Yale UniversityEyal Dassau, PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534544
- Sponsor's protocol ID
- CHS2018-05
- Other IDs
- DP3DK113511
- Status last verified
- Aug 2021
- First submitted
- 20 Apr 2018
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Qualitative data may be available after removal of all personal identifiers.
Publications
Commissariat PV, Volkening LK, Butler DA, Dassau E, Weinzimer SA, Laffel LM. Innovative features and functionalities of an artificial pancreas system: What do youth and parents want? Diabet Med. 2021 Oct;38(10):e14492. doi: 10.1111/dme.14492. Epub 2021 Jan 20.
PubMed 33290599Commissariat PV, Roethke LC, Finnegan JL, Guo Z, Volkening LK, Butler DA, Dassau E, Weinzimer SA, Laffel LM. Youth and parent preferences for an ideal AP system: It is all about reducing burden. Pediatr Diabetes. 2021 Nov;22(7):1063-1070. doi: 10.1111/pedi.13252. Epub 2021 Aug 9.
PubMed 34324772
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Parent Preferences for an On-Body Automated Insulin Delivery System
- ClinicalTrials.gov ID
- NCT03534544
- Acronym / sponsor ID
- CHS2018-05
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- artificial pancreas, pediatric, parents, adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 23 May 2018 (actual)
- 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 goal of this study is to learn more about patient and family preferences regarding use of advanced diabetes technologies. Young persons with type 1 diabetes (ages 8-25) and parents of young persons with type 1 diabetes will complete one study visit involving a semi-structured interview and surveys. The results of the study will be used to assist in the design of a new automated insulin delivery system.
Detailed description
Type 1 diabetes remains the most common chronic disease of childhood and affects millions of children and adults globally. The minority of persons with type 1 diabetes achieve the recommended glycemic targets. Currently approved and unapproved automated insulin delivery systems require patients to carry and wear multiple devices (pumps, tubing, blood glucose meters, mobile devices, etc.). There is a need to design automated insulin delivery systems that reduce the burden of diabetes management for young persons and their families in an effort to improve glycemic control as well as other biomedical and psychosocial outcomes.
The purpose of this study is to conduct separate semi-structured interviews with young persons with type 1 diabetes and parents of youth with type 1 diabetes (not necessarily the parents of the youth participants) regarding their preferences for an automated, on-body insulin delivery system. Youth and parents will also complete short surveys related to perceived burden of diabetes self-care, quality of life, acceptance of diabetes, and worries about hypoglycemia. The feedback received from the interviews and surveys will help inform the design of a new on-body automated insulin delivery system.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will be recruited from the clinic populations of the 2 study sites.
Key inclusion criteria (2 listed)
- Young persons (ages 8-25 years) with type 1 diabetes for 1 year or longer
- Parents of young persons with type 1 diabetes
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Youth and parent preferences for automated insulin delivery systems
Time frame: 1 day
Semi-structured interviews with young persons with type 1 diabetes and parents; interviews will be transcribed and analyzed to derive central themes; this is a qualitative outcome
4 secondary outcomes
Diabetes burden
Time frame: 1 day
Worries about hypoglycemia
Time frame: 1 day
Diabetes acceptance
Time frame: 1 day
Quality of life
Time frame: 1 day
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 10 Aug 2021.
- Results publication: PubMed 33290599Commissariat PV, Volkening LK, Butler DA, Dassau E, Weinzimer SA, Laffel LM. Innovative features and functionalities of an artificial pancreas system: What do youth and parents want? Diabet Med. 2021 Oct;38(10):e14492. doi: 10.1111/dme.14492. Epub 2021 Jan 20.
- Results publication: PubMed 34324772Commissariat PV, Roethke LC, Finnegan JL, Guo Z, Volkening LK, Butler DA, Dassau E, Weinzimer SA, Laffel LM. Youth and parent preferences for an ideal AP system: It is all about reducing burden. Pediatr Diabetes. 2021 Nov;22(7):1063-1070. doi: 10.1111/pedi.13252. Epub 2021 Aug 9.
- Individual participant dataSharing planned: Undecided. Qualitative data may be available after removal of all personal identifiers.
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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.
Lori Laffel, MD, MPH principal investigator
Joslin Diabetes Center
Stuart Weinzimer, MD principal investigator
Yale University
Eyal Dassau, PhD principal investigator
Harvard University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Joslin Diabetes Center at 2 sites 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 2 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 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Youth and parent preferences for automated insulin delivery systems (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03534544, which also lists 2 linked publications.
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 10 Aug 2021.