Automated Insulin Delivery vs. Injections: Sleep Impact in Pediatric Type 1 Diabetes

NCT06347783 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00026893
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Sleep Disturbance Scale for Children

  4 months

• Promis Short Form 8a

  4 months

Other Outcomes (1)

• Time in range

  4 months

Study Arms (1)

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.

Device: Insulin pump

Interventions

Insulin pump DEVICE

Continuous subcutaneous insulin therapy.

Child/parent dyad

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (13)

• 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.

  PMID: 33180913 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.

  PMID: 27692274 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.

  PMID: 12663593 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.

  PMID: 29157581 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.

  PMID: 10931417 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.

  PMID: 22825805 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.

  PMID: 20658206 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.

  PMID: 27028035 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.

  PMID: 27081578 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.

  PMID: 30447038 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.

  PMID: 19742409 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.

  PMID: 26683701 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.

  PMID: 12470913 BACKGROUND

MeSH Terms

Interventions

Insulin Infusion Systems

Intervention Hierarchy (Ancestors)

Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Rachel L Palting, DO

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel L Palting, DO

CONTACT

503-494-1966; palting@ohsu.edu

Ines Guttman-Bauman, MD

CONTACT

503-494-8509; Guttman@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric endocrinology fellow

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: May 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: December 15, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)