Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
After 1-2 months after initiation of an insulin pump, participants will be asked again to:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin pump | Device | Continuous subcutaneous insulin therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep duration | Number of hours and minutes measured by FitBit | 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. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Disturbance Scale for Children | Measures sleep disturbances in children and adolescents, with a T-score ranging from 38 to >100 | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Time in range | Measures of blood glucose levels during sleep, frequency of hypoglycemic/hyperglycemic events obtained through CGM data. | 4 months |
Inclusion Criteria:
i. 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.
iv. 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.
vi. Informed Consent: Participants (if aged 18 or older) or their legal guardians must provide informed consent for participation in the study.
Exclusion Criteria:
i. Diagnosis: Participants with a diagnosis other than Type 1 Diabetes (e.g. Type 2 Diabetes or MODY).
ii. Age: Participants outside the age range of 6 to 18 years. iii. Treatment modality:
vii. 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.
viii. Pregnancy: Pregnancy can significantly affect insulin requirements and sleep patterns.
ix. Allergy or Sensitivity: Participants with known allergies or sensitivities to materials used in Fitbit devices or related equipment.
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel L Palting, DO | Contact | 503-494-1966 | palting@ohsu.edu | |
| Ines Guttman-Bauman, MD | Contact | 503-494-8509 | Guttman@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rachel L Palting, DO | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33180913 | Background | 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. | |
| 27692274 | Background | Reutrakul 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007332 | Insulin Infusion Systems |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
Not provided
Not provided
Not provided
Not provided
Not provided
| 4 months |
| 12663593 | Background | Leese 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. |
| 29157581 | Background | Jaser 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. |
| 10931417 | Background | Matyka 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. |
| 22825805 | Background | Brod 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. |
| 20658206 | Background | O'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. |
| 27028035 | Background | McDonough 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. |
| 27081578 | Background | Jaser 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. |
| 30447038 | Background | Monzon 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. |
| 19742409 | Background | Goel 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. |
| 26683701 | Background | Quist 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. |
| 12470913 | Background | Dahl 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. |
| D004864 |
| Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |