Type1diabetesNCT06347783
Automated Insulin Delivery vs. Injections: Sleep Impact in Pediatric Type 1 Diabetes
An observational study of Type1diabetes, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of the study is to learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. We are hoping to find out if insulin pumps improve sleep, worsen sleep, or have no effect at all. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Insulin pump
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 15 Dec 2024
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study will include pediatric patients diagnosed with Type 1 Diabetes ages 6-18 years currently using multiple daily injections combined with a continuous glucose monitor, eligible for an insulin pump. For this pilot study, a sample size of 40 patients with their caregivers, for a total of 80 individuals.
Who may be able to join
- Diagnosis: Type 1 diabetes for at least 6 months ii. Age: Participants must be aged between 6-18 years at time of enrollment iii. Treatment modality: Participants must be currently receiving treatment for Type 1 Diabetes through multiple daily injections of insulin, with concomitant use of a continuous glucose monitor, with data sharing through Clarity. Participants must be eligible for an insulin pump, based on individual provider discretion.
- Smartphone access, ability to download FitBit application. v. Language: Participants and their guardians must be able to understand and communicate in the primary language(s) used for study-related instructions and questionnaires, which include a demographic survey, questions about diabetes history, two surveys regarding patient and caregiver sleep, and a daily sleep diary.
- Informed Consent: Participants (if aged 18 or older) or their legal guardians must provide informed consent for participation in the study.
Who cannot join
- Diagnosis: Participants with a diagnosis other than Type 1 Diabetes (e.g. Type 2 Diabetes or MODY).
- Age: Participants outside the age range of 6 to 18 years. iii. Treatment modality:
- Participants currently not receiving multiple daily injections of insulin.
- Participants currently not using a continuous glucose monitor. iv. Participants ineligible for an insulin pump. v. No access to smartphone vi. Inadequate language proficiency: Participants or guardians that cannot communicate effectively in the primary study language.
- If a participant is otherwise eligible for the study, a modification may be submitted to the IRB to include the participant in the study. However, language barrier is not an obstacle for a patient to receive standard care in the clinic.
- Pregnancy: Pregnancy can significantly affect insulin requirements and sleep patterns.
- Allergy or Sensitivity: Participants with known allergies or sensitivities to materials used in Fitbit devices or related equipment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
Rachel L Palting, DO, 503-494-1966, palting@ohsu.edu
Ines Guttman-Bauman, MD, 503-494-8509, Guttman@ohsu.edu
About this study
Official title: The Effect of Automated Insulin Delivery on Sleep Compared to Multiple Daily Injections in Pediatric Patients With Type 1 Diabetes
The purpose of the study is to learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. We are hoping to find out if insulin pumps improve sleep, worsen sleep, or have no effect at all. We are hoping to also explore the relationship between insulin pumps, sleep, and overnight blood sugar control. Your information will not be stored and used for future research.
The goal of this observational study is learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. The main questions it aims to answer are:
Read more
Do insulin pumps improve sleep, worsen sleep or have no effect at all? What is the relationship between insulin pumps, sleep, and overnight blood sugar control?
Participants will be asked to:
- Complete questionnaires regarding demographic data and diabetes history.
- Complete surveys regarding sleep quality before and after starting an insulin pump.
- Wear a FitBit during sleep for 2 weeks and fill out daily sleep diaries over a 2 week period prior to starting an insulin pump.
After 1-2 months after initiation of an insulin pump, participants will be asked again to:
- Complete surveys regarding sleep quality
- Wear a FitBit during sleep for 2 weeks
- Fill out daily sleep diaries over the same 2 week period.
- Conditions
- Type1diabetes
- Being tested
- Insulin pump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin pumpDevice
Continuous subcutaneous insulin therapy.
| Study group | Role | What they receive |
|---|---|---|
| Child/parent dyad | Study group will consist of 40 participant dyads - a pediatric patient with type 1 diabetes and one of their caregivers. At the beginning of the study, the patient's treatment should consist of multiple daily insulin injections and a continuous glucose monitor, and during this time, sleep will be evaluated through a FitBit and surveys. Then patient will be started on an insulin pump of their choice (Omnipod 5, Tandem, etc), and sleep will be re-evaluated 1-2 months after pump initiation. Receives: Device: Insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep duration
Number of hours and minutes measured by FitBit
Measured: 4 months
Sleep efficiency
The percentage of time spent asleep while in bed, calculated as the ratio of total sleep time to total time spent in bed.
Measured: 4 months
Secondary outcomes (2)
Sleep Disturbance Scale for Children
Measures sleep disturbances in children and adolescents, with a T-score ranging from 38 to >100
Measured: 4 months
Promis Short Form 8a
Assess sleep disturbances in caregivers, converts a raw score (8-40) to a T-score (30.5-77.5).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start15 May 2024 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Palting, Oregon Health and Science University
- Investigators
- Rachel L Palting, DO, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347783
- Sponsor's protocol ID
- STUDY00026893
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jaser SS, Bergner EM, Hamburger ER, Bhatia S, Lyttle M, Bell GE, Slaughter JC, Malow BA, Simmons JH. Pilot Trial of a Sleep-Promoting Intervention for Children With Type 1 Diabetes. J Pediatr Psychol. 2021 Mar 18;46(3):304-313. doi: 10.1093/jpepsy/jsaa105.
PubMed 33180913Reutrakul S, Thakkinstian A, Anothaisintawee T, Chontong S, Borel AL, Perfect MM, Janovsky CC, Kessler R, Schultes B, Harsch IA, van Dijk M, Bouhassira D, Matejko B, Lipton RB, Suwannalai P, Chirakalwasan N, Schober AK, Knutson KL. Sleep characteristics in type 1 diabetes and associations with glycemic control: systematic review and meta-analysis. Sleep Med. 2016 Jul;23:26-45. doi: 10.1016/j.sleep.2016.03.019. Epub 2016 Jun 8.
PubMed 27692274Leese GP, Wang J, Broomhall J, Kelly P, Marsden A, Morrison W, Frier BM, Morris AD; DARTS/MEMO Collaboration. Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use. Diabetes Care. 2003 Apr;26(4):1176-80. doi: 10.2337/diacare.26.4.1176.
PubMed 12663593Jaser SS, Foster NC, Nelson BA, Kittelsrud JM, DiMeglio LA, Quinn M, Willi SM, Simmons JH; T1D Exchange Clinic Network. Sleep in children with type 1 diabetes and their parents in the T1D Exchange. Sleep Med. 2017 Nov;39:108-115. doi: 10.1016/j.sleep.2017.07.005. Epub 2017 Jul 18.
PubMed 29157581Matyka KA, Crawford C, Wiggs L, Dunger DB, Stores G. Alterations in sleep physiology in young children with insulin-dependent diabetes mellitus: relationship to nocturnal hypoglycemia. J Pediatr. 2000 Aug;137(2):233-8. doi: 10.1067/mpd.2000.107186.
PubMed 10931417Brod M, Pohlman B, Wolden M, Christensen T. Non-severe nocturnal hypoglycemic events: experience and impacts on patient functioning and well-being. Qual Life Res. 2013 Jun;22(5):997-1004. doi: 10.1007/s11136-012-0234-3. Epub 2012 Jul 24.
PubMed 22825805O'Reilly M, O'Sullivan EP, Davenport C, Smith D. "Dead in bed": a tragic complication of type 1 diabetes mellitus. Ir J Med Sci. 2010 Dec;179(4):585-7. doi: 10.1007/s11845-010-0519-x. Epub 2010 Jul 24.
PubMed 20658206McDonough RJ, Clements MA, DeLurgio SA, Patton SR. Sleep duration and its impact on adherence in adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2017 Jun;18(4):262-270. doi: 10.1111/pedi.12381. Epub 2016 Mar 30.
PubMed 27028035Jaser SS, Ellis D. Sleep in Adolescents and Young Adults with Type 1 Diabetes: Associations with Diabetes Management and Glycemic Control. Health Psychol Behav Med. 2016 Jan 1;4(1):49-55. doi: 10.1080/21642850.2015.1135293. Epub 2016 Mar 2.
PubMed 27081578Monzon A, McDonough R, Meltzer LJ, Patton SR. Sleep and type 1 diabetes in children and adolescents: Proposed theoretical model and clinical implications. Pediatr Diabetes. 2019 Feb;20(1):78-85. doi: 10.1111/pedi.12797. Epub 2018 Dec 4.
PubMed 30447038Goel N, Rao H, Durmer JS, Dinges DF. Neurocognitive consequences of sleep deprivation. Semin Neurol. 2009 Sep;29(4):320-39. doi: 10.1055/s-0029-1237117. Epub 2009 Sep 9.
PubMed 19742409Quist JS, Sjodin A, Chaput JP, Hjorth MF. Sleep and cardiometabolic risk in children and adolescents. Sleep Med Rev. 2016 Oct;29:76-100. doi: 10.1016/j.smrv.2015.09.001. Epub 2015 Sep 12.
PubMed 26683701Dahl RE, Lewin DS. Pathways to adolescent health sleep regulation and behavior. J Adolesc Health. 2002 Dec;31(6 Suppl):175-84. doi: 10.1016/s1054-139x(02)00506-2.
PubMed 12470913
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Automated Insulin Delivery on Sleep Compared to Multiple Daily Injections in Pediatric Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06347783
- Acronym / sponsor ID
- STUDY00026893
- Conditions
- Type1diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 4 Apr 2024 (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 purpose of the study is to learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. We are hoping to find out if insulin pumps improve sleep, worsen sleep, or have no effect at all. We are hoping to also explore the relationship between insulin pumps, sleep, and overnight blood sugar control. Your information will not be stored and used for future research.
The goal of this observational study is learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. The main questions it aims to answer are:
Do insulin pumps improve sleep, worsen sleep or have no effect at all? What is the relationship between insulin pumps, sleep, and overnight blood sugar control?
Participants will be asked to:
- Complete questionnaires regarding demographic data and diabetes history.
- Complete surveys regarding sleep quality before and after starting an insulin pump.
- Wear a FitBit during sleep for 2 weeks and fill out daily sleep diaries over a 2 week period prior to starting an insulin pump.
After 1-2 months after initiation of an insulin pump, participants will be asked again to:
- Complete surveys regarding sleep quality
- Wear a FitBit during sleep for 2 weeks
- Fill out daily sleep diaries over the same 2 week period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Child/parent dyad | – | Device: Insulin pumpStudy group will consist of 40 participant dyads - a pediatric patient with type 1 diabetes and one of their caregivers. At the beginning of the study, the patient's treatment should consist of multiple daily insulin injections and a continuous glucose monitor, and during this time, sleep will be evaluated through a FitBit and surveys. Then patient will be started on an insulin pump of their choice (Omnipod 5, Tandem, etc), and sleep will be re-evaluated 1-2 months after pump initiation. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study will include pediatric patients diagnosed with Type 1 Diabetes ages 6-18 years currently using multiple daily injections combined with a continuous glucose monitor, eligible for an insulin pump. For this pilot study, a sample size of 40 patients with their caregivers, for a total of 80 individuals.
Key inclusion criteria (3 listed)
- Diagnosis: Type 1 diabetes for at least 6 months ii. Age: Participants must be aged between 6-18 years at time of enrollment iii. Treatment modality: Participants must be currently receiving treatment for Type 1 Diabetes through multiple daily injections of insulin, with concomitant use of a continuous glucose monitor, with data sharing through Clarity. Participants must be eligible for an insulin pump, based on individual provider discretion.
- Smartphone access, ability to download FitBit application. v. Language: Participants and their guardians must be able to understand and communicate in the primary language(s) used for study-related instructions and questionnaires, which include a demographic survey, questions about diabetes history, two surveys regarding patient and caregiver sleep, and a daily sleep diary.
- Informed Consent: Participants (if aged 18 or older) or their legal guardians must provide informed consent for participation in the study.
Key exclusion criteria (7 listed)
- Diagnosis: Participants with a diagnosis other than Type 1 Diabetes (e.g. Type 2 Diabetes or MODY).
- Age: Participants outside the age range of 6 to 18 years. iii. Treatment modality:
- Participants currently not receiving multiple daily injections of insulin.
- Participants currently not using a continuous glucose monitor. iv. Participants ineligible for an insulin pump. v. No access to smartphone vi. Inadequate language proficiency: Participants or guardians that cannot communicate effectively in the primary study language.
- If a participant is otherwise eligible for the study, a modification may be submitted to the IRB to include the participant in the study. However, language barrier is not an obstacle for a patient to receive standard care in the clinic.
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 |
|---|---|---|
| Insulin pumpContinuous subcutaneous insulin therapy. | Device | Child/parent dyad |
Primary outcome
Sleep duration
Time frame: 4 months
Number of hours and minutes measured by FitBit
Sleep efficiency
Time frame: 4 months
The percentage of time spent asleep while in bed, calculated as the ratio of total sleep time to total time spent in bed.
2 secondary outcomes
Sleep Disturbance Scale for Children
Time frame: 4 months
Promis Short Form 8a
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Background: PubMed 33180913Jaser SS, Bergner EM, Hamburger ER, Bhatia S, Lyttle M, Bell GE, Slaughter JC, Malow BA, Simmons JH. Pilot Trial of a Sleep-Promoting Intervention for Children With Type 1 Diabetes. J Pediatr Psychol. 2021 Mar 18;46(3):304-313. doi: 10.1093/jpepsy/jsaa105.
- Background: PubMed 27692274Reutrakul S, Thakkinstian A, Anothaisintawee T, Chontong S, Borel AL, Perfect MM, Janovsky CC, Kessler R, Schultes B, Harsch IA, van Dijk M, Bouhassira D, Matejko B, Lipton RB, Suwannalai P, Chirakalwasan N, Schober AK, Knutson KL. Sleep characteristics in type 1 diabetes and associations with glycemic control: systematic review and meta-analysis. Sleep Med. 2016 Jul;23:26-45. doi: 10.1016/j.sleep.2016.03.019. Epub 2016 Jun 8.
- Background: PubMed 12663593Leese GP, Wang J, Broomhall J, Kelly P, Marsden A, Morrison W, Frier BM, Morris AD; DARTS/MEMO Collaboration. Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use. Diabetes Care. 2003 Apr;26(4):1176-80. doi: 10.2337/diacare.26.4.1176.
- Background: PubMed 29157581Jaser SS, Foster NC, Nelson BA, Kittelsrud JM, DiMeglio LA, Quinn M, Willi SM, Simmons JH; T1D Exchange Clinic Network. Sleep in children with type 1 diabetes and their parents in the T1D Exchange. Sleep Med. 2017 Nov;39:108-115. doi: 10.1016/j.sleep.2017.07.005. Epub 2017 Jul 18.
- Background: PubMed 10931417Matyka KA, Crawford C, Wiggs L, Dunger DB, Stores G. Alterations in sleep physiology in young children with insulin-dependent diabetes mellitus: relationship to nocturnal hypoglycemia. J Pediatr. 2000 Aug;137(2):233-8. doi: 10.1067/mpd.2000.107186.
- Background: PubMed 22825805Brod M, Pohlman B, Wolden M, Christensen T. Non-severe nocturnal hypoglycemic events: experience and impacts on patient functioning and well-being. Qual Life Res. 2013 Jun;22(5):997-1004. doi: 10.1007/s11136-012-0234-3. Epub 2012 Jul 24.
- Background: PubMed 20658206O'Reilly M, O'Sullivan EP, Davenport C, Smith D. "Dead in bed": a tragic complication of type 1 diabetes mellitus. Ir J Med Sci. 2010 Dec;179(4):585-7. doi: 10.1007/s11845-010-0519-x. Epub 2010 Jul 24.
- Background: PubMed 27028035McDonough RJ, Clements MA, DeLurgio SA, Patton SR. Sleep duration and its impact on adherence in adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2017 Jun;18(4):262-270. doi: 10.1111/pedi.12381. Epub 2016 Mar 30.
- Background: PubMed 27081578Jaser SS, Ellis D. Sleep in Adolescents and Young Adults with Type 1 Diabetes: Associations with Diabetes Management and Glycemic Control. Health Psychol Behav Med. 2016 Jan 1;4(1):49-55. doi: 10.1080/21642850.2015.1135293. Epub 2016 Mar 2.
- Background: PubMed 30447038Monzon A, McDonough R, Meltzer LJ, Patton SR. Sleep and type 1 diabetes in children and adolescents: Proposed theoretical model and clinical implications. Pediatr Diabetes. 2019 Feb;20(1):78-85. doi: 10.1111/pedi.12797. Epub 2018 Dec 4.
- Background: PubMed 19742409Goel N, Rao H, Durmer JS, Dinges DF. Neurocognitive consequences of sleep deprivation. Semin Neurol. 2009 Sep;29(4):320-39. doi: 10.1055/s-0029-1237117. Epub 2009 Sep 9.
- Background: PubMed 26683701Quist JS, Sjodin A, Chaput JP, Hjorth MF. Sleep and cardiometabolic risk in children and adolescents. Sleep Med Rev. 2016 Oct;29:76-100. doi: 10.1016/j.smrv.2015.09.001. Epub 2015 Sep 12.
- Individual participant dataSharing planned: No
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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.
Rachel L Palting, DO principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes, run by Oregon Health and Science University 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 7 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: status not confirmed, as of the sponsor's last update on 4 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel L Palting, DO (503-494-1966, palting@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep duration (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT06347783, which also lists 13 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 4 Apr 2024.