Accelerometer Use in the Prevention of Exercise-Associated Hypoglycemia in Type 1 Diabetes: Outpatient Exercise Protocol

NCT02047643 | Completed Results FDA Device

• 1 other identifier: 29205
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Manually suspending an insulin pump at the beginning of aerobic exercise reduces the risk of exercise-associated hypoglycemia (low blood sugar) in patients with type 1 diabetes (T1D). However, since patients with T1D often do not make exercise-related adjustments to their insulin regimen, our group has developed an algorithm to initiate pump suspension in a user-independent manner upon projecting exercise-associated hypoglycemia. The current study seeks to test the efficacy of this algorithm by asking users to participate in a sports camp while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which will communicate electronically to a pump shutoff algorithm. On one of the days the algorithm will be used, while on the other day their normal insulin rate will continue for comparative purposes. The investigators hypothesize that the use of an accelerometer-augmented computer algorithm for insulin pump suspension during exercise will result in significantly fewer episodes of hypoglycemia (both during exercise and in post-exercise monitoring) than in exercise without a pump suspension algorithm.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; Hypoglycemia; Accelerometer

Outcome Measures

Primary Outcomes (1)

• Count of Participants Experiencing a Hypoglycemic Event During Scheduled Exercise

  The primary outcome will be a hypoglycemic event defined as (1) any meter blood glucose (BG) reading of ≤60 mg/dl, (2) two consecutive meter BG readings ≤70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia

  Measurements occurring during exercise (up to 8 hours)

Secondary Outcomes (1)

• Count of Participants With Hypoglycemia in the Post Exercise Period

  In the time following exercise until the following morning (up to 24 hours)

Study Arms (2)

On-algorithm first, then Off-algorithm

EXPERIMENTAL

Users will participate in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm is turned on; on the other day, the algorithm is turned off.

Device: Computer algorithm to initiate pump suspension

Off-algorithm first, then On-algorithm

EXPERIMENTAL

Users will participate in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm is turned on; on the other day, the algorithm is turned off.

Device: Computer algorithm to initiate pump suspension

Interventions

Computer algorithm to initiate pump suspension DEVICE

If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump

Also known as: Augmented predictive low glucose suspend algorithm

Off-algorithm first, then On-algorithm; On-algorithm first, then Off-algorithm

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of type 1 diabetes for 1-20 years. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
• Age 8 to 25 years old.
• On daily use of an insulin pump and not anticipating a change prior to the subject's completion of the study.
• Willingness to allow for CGM insertion (if not already using a study-designated CGM) for use during the study.
• HbA1c \<10%.
• Parent/guardian and subject understand the study protocol and agree to comply with it.
• Informed Consent Form signed by the parent/guardian and Child Assent Form signed.

You may not qualify if:

• A history of recent injury to body or limb, Addison's disease, muscular disorder, organ/bone marrow transplant, heart disease, or use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
• Current use of glucocorticoid medication (by any route of administration).
• Current use of a beta blocker medication.
• Severe hypoglycemia resulting in seizure or loss of consciousness in the four weeks prior to sports camp (if a severe episode occurs after the first but prior to the scheduled second admission, the visit will be deferred).
• Active infection (if at the time of the planned second visit an infection is present, the visit will be deferred).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (19)

• American Diabetes Association. Physical activity/exercise and diabetes. Diabetes Care. 2004 Jan;27 Suppl 1:S58-62. doi: 10.2337/diacare.27.2007.s58. No abstract available.

  PMID: 14693927 BACKGROUND

• Sonnenberg GE, Kemmer FW, Berger M. Exercise in type 1 (insulin-dependent) diabetic patients treated with continuous subcutaneous insulin infusion. Prevention of exercise induced hypoglycaemia. Diabetologia. 1990 Nov;33(11):696-703. doi: 10.1007/BF00400572.

  PMID: 2076801 BACKGROUND

• MacDonald MJ. Postexercise late-onset hypoglycemia in insulin-dependent diabetic patients. Diabetes Care. 1987 Sep-Oct;10(5):584-8. doi: 10.2337/diacare.10.5.584.

  PMID: 3677976 BACKGROUND

• Tuominen JA, Karonen SL, Melamies L, Bolli G, Koivisto VA. Exercise-induced hypoglycaemia in IDDM patients treated with a short-acting insulin analogue. Diabetologia. 1995 Jan;38(1):106-11. doi: 10.1007/BF02369359.

  PMID: 7744214 BACKGROUND

• Rabasa-Lhoret R, Bourque J, Ducros F, Chiasson JL. Guidelines for premeal insulin dose reduction for postprandial exercise of different intensities and durations in type 1 diabetic subjects treated intensively with a basal-bolus insulin regimen (ultralente-lispro). Diabetes Care. 2001 Apr;24(4):625-30. doi: 10.2337/diacare.24.4.625.

  PMID: 11315820 BACKGROUND

• Bernardini AL, Vanelli M, Chiari G, Iovane B, Gelmetti C, Vitale R, Errico MK. Adherence to physical activity in young people with type 1 diabetes. Acta Biomed. 2004 Dec;75(3):153-7.

  PMID: 15796088 BACKGROUND

• Devadoss M, Kennedy L, Herbold N. Endurance athletes and type 1 diabetes. Diabetes Educ. 2011 Mar-Apr;37(2):193-207. doi: 10.1177/0145721710395782. Epub 2011 Feb 15.

  PMID: 21325065 BACKGROUND

• Buckingham B, Cobry E, Clinton P, Gage V, Caswell K, Kunselman E, Cameron F, Chase HP. Preventing hypoglycemia using predictive alarm algorithms and insulin pump suspension. Diabetes Technol Ther. 2009 Feb;11(2):93-7. doi: 10.1089/dia.2008.0032.

  PMID: 19848575 BACKGROUND

• Cengiz E, Swan KL, Tamborlane WV, Steil GM, Steffen AT, Weinzimer SA. Is an automatic pump suspension feature safe for children with type 1 diabetes? An exploratory analysis with a closed-loop system. Diabetes Technol Ther. 2009 Apr;11(4):207-10. doi: 10.1089/dia.2008.0102.

  PMID: 19344194 BACKGROUND

• Buckingham B, Chase HP, Dassau E, Cobry E, Clinton P, Gage V, Caswell K, Wilkinson J, Cameron F, Lee H, Bequette BW, Doyle FJ 3rd. Prevention of nocturnal hypoglycemia using predictive alarm algorithms and insulin pump suspension. Diabetes Care. 2010 May;33(5):1013-7. doi: 10.2337/dc09-2303. Epub 2010 Mar 3.

  PMID: 20200307 BACKGROUND

• Diabetes Research in Children Network (DirecNet) Study Group; Tsalikian E, Kollman C, Tamborlane WB, Beck RW, Fiallo-Scharer R, Fox L, Janz KF, Ruedy KJ, Wilson D, Xing D, Weinzimer SA. Prevention of hypoglycemia during exercise in children with type 1 diabetes by suspending basal insulin. Diabetes Care. 2006 Oct;29(10):2200-4. doi: 10.2337/dc06-0495.

  PMID: 17003293 BACKGROUND

• Plasqui G, Westerterp KR. Physical activity assessment with accelerometers: an evaluation against doubly labeled water. Obesity (Silver Spring). 2007 Oct;15(10):2371-9. doi: 10.1038/oby.2007.281.

  PMID: 17925461 BACKGROUND

• Gradmark A, Pomeroy J, Renstrom F, Steiginga S, Persson M, Wright A, Bluck L, Domellof M, Kahn SE, Mogren I, Franks PW. Physical activity, sedentary behaviors, and estimated insulin sensitivity and secretion in pregnant and non-pregnant women. BMC Pregnancy Childbirth. 2011 Jun 16;11:44. doi: 10.1186/1471-2393-11-44.

  PMID: 21679399 BACKGROUND

• Balkau B, Mhamdi L, Oppert JM, Nolan J, Golay A, Porcellati F, Laakso M, Ferrannini E; EGIR-RISC Study Group. Physical activity and insulin sensitivity: the RISC study. Diabetes. 2008 Oct;57(10):2613-8. doi: 10.2337/db07-1605. Epub 2008 Jun 30.

  PMID: 18591396 BACKGROUND

• Ekelund U, Griffin SJ, Wareham NJ. Physical activity and metabolic risk in individuals with a family history of type 2 diabetes. Diabetes Care. 2007 Feb;30(2):337-42. doi: 10.2337/dc06-1883.

  PMID: 17259504 BACKGROUND

• Simmons RK, Griffin SJ, Steele R, Wareham NJ, Ekelund U; ProActive Research Team. Increasing overall physical activity and aerobic fitness is associated with improvements in metabolic risk: cohort analysis of the ProActive trial. Diabetologia. 2008 May;51(5):787-94. doi: 10.1007/s00125-008-0949-4. Epub 2008 Mar 4.

  PMID: 18317727 BACKGROUND

• Healy GN, Wijndaele K, Dunstan DW, Shaw JE, Salmon J, Zimmet PZ, Owen N. Objectively measured sedentary time, physical activity, and metabolic risk: the Australian Diabetes, Obesity and Lifestyle Study (AusDiab). Diabetes Care. 2008 Feb;31(2):369-71. doi: 10.2337/dc07-1795. Epub 2007 Nov 13.

  PMID: 18000181 BACKGROUND

• Arvidsson D, Fitch M, Hudes ML, Tudor-Locke C, Fleming SE. Accelerometer response to physical activity intensity in normal-weight versus overweight African American children. J Phys Act Health. 2011 Jul;8(5):682-92. doi: 10.1123/jpah.8.5.682.

  PMID: 21734314 BACKGROUND

• Stenerson M, Cameron F, Payne SR, Payne SL, Ly TT, Wilson DM, Buckingham BA. The impact of accelerometer use in exercise-associated hypoglycemia prevention in type 1 diabetes. J Diabetes Sci Technol. 2015 Jan;9(1):80-5. doi: 10.1177/1932296814551045. Epub 2014 Sep 17.

  PMID: 25231116 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Bruce Buckingham, M.D.
• Organization: Stanford University

buckingham@stanford.edu

408-356-0911

Study Officials

• Bruce A Buckingham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Endocrinology

Model Details: randomized crossover design. Subjects with type 1 diabetes participated in a structured soccer session on two separate dates at least one week apart. During one session a subject's basal insulin rate was continued ("off-algorithm"), while during the other session the algorithm (see "algorithm monitoring" below) was in effect ("on-algorithm"); the order of on- versus off-algorithm was chosen at random. The rate of hypoglycemia during exercise were compared between each group. Hypoglycemia was defined as (1) any meter blood glu cose (BG) reading of =60 mg/dl, (2) two consecutive meter BG readings =70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia (regardless of corre sponding meter BG reading).

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 28, 2014
• Study Start: March 12, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 27, 2019
• Results First Posted: October 22, 2019

Record last verified: 2019-12

Locations

US (1)