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

Type1diabetes Clinical Trial

Official title:

The Effect of Automated Insulin Delivery on Sleep Compared to Multiple Daily Injections in Pediatric Patients With Type 1 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06347783
• Other study ID #: STUDY00026893
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: March 2024
• Source: Oregon Health and Science University
• Contact: Rachel L Palting, DO
• Phone: 503-494-1966
• Email: palting[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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:

1. Participants currently not receiving multiple daily injections of insulin.

2. 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Device:
• Insulin pump
Continuous subcutaneous insulin therapy.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time in range	Measures of blood glucose levels during sleep, frequency of hypoglycemic/hyperglycemic events obtained through CGM data.	4 months
Primary	Sleep duration	Number of hours and minutes measured by FitBit	4 months
Primary	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	Sleep Disturbance Scale for Children	Measures sleep disturbances in children and adolescents, with a T-score ranging from 38 to >100	4 months
Secondary	Promis Short Form 8a	Assess sleep disturbances in caregivers, converts a raw score (8-40) to a T-score (30.5-77.5).	4 months