Insulin Management for Exercise in Patients With Type 1 Diabetes

NCT03130101 | Completed

• 1 other identifier: e2017 - 073
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the time spent in glucose target range (4.0-10.0 mmol/L) during exercise and in recovery using three different basal insulin management strategies for prolonged aerobic exercise: A) pump suspension for the duration of the activity, starting at the onset of exercise; B) A 50% basal rate reduction, performed 90-minutes in advance of exercise for the duration of the activity; and C) An 80% basal rate reduction, performed 90-minutes in advance of exercise for the duration of the activity.

Conditions

Type 1 Diabetes; Hypoglycemia; Physical Activity

Keywords

Type 1 Diabetes; Exercise; Basal insulin; CSII; OmniPod; CGM

Outcome Measures

Primary Outcomes (1)

• Time in interstitial glucose target range (CGM analysis)

  The primary outcome for this study will be the time spent in target range during the 75-minute exercise session and during the three hours post-meal recovery period using CGM analysis. For this, interstitial glucose levels will be classified as below target, in target, or above target range.

  Approximately 4-5 hours

Study Arms (3)

80% basal insulin reduction

OTHER

Other: Change in their basal insulin rate

50% basal insulin reduction

OTHER

Other: Change in their basal insulin rate

100% basal insulin reduction

OTHER

Other: Change in their basal insulin rate

Interventions

Change in their basal insulin rate OTHER

Individual with type 1 diabetes on insulin pump therapy typically lower their basal insulin delivery for exercise. This study will compare 3 common strategies of basal insulin reductions for 75 minutes of aerobic exercise.

100% basal insulin reduction; 50% basal insulin reduction; 80% basal insulin reduction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin
• Last A1C ≤ 9.9%
• Age: 18-65 years
• Duration of T1D: ≥ 2 years
• Using CSII via OmniPod® for at least 1 month (\~50:50 bolus basal insulin ratio and on at least .25 units of insulin per kilogram body mass per day)
• Body mass index (BMI) \< 30 kg/m2
• In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
• Willing to adhere to the protocol requirements for the duration of the study

You may not qualify if:

• Physician diagnosis of active diabetic retinopathy (proliferative or hemorrhage in past 6 months) that could potentially be worsened by exercise
• Physician diagnosis of peripheral neuropathy with insensate feet
• Physician diagnosis of autonomic neuropathy
• Medications: Beta blockers, agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives, Pramlinitide, any other hypoglycemic agent
• Participation in other studies involving administration of an investigational drug or device at the time of screening for the current study or planning to participate in another such study during participation in the current study
• Severe hypoglycemic event defined as the individual requiring third party assistance or hospitalization in the last 3 months

Sponsors & Collaborators

• York University: lead

Study Sites (1)

York University

Toronto, Ontario, M3J 1P3, Canada

Location

Related Publications (1)

• Zaharieva DP, McGaugh S, Pooni R, Vienneau T, Ly T, Riddell MC. Improved Open-Loop Glucose Control With Basal Insulin Reduction 90 Minutes Before Aerobic Exercise in Patients With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion. Diabetes Care. 2019 May;42(5):824-831. doi: 10.2337/dc18-2204. Epub 2019 Feb 22.

  PMID: 30796112 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael C Riddell, PhD

  York University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Patients with type 1 diabetes on insulin pump therapy will remain on their usual insulin regimen. However, we are testing percent basal rate reductions during exercise (e.g. 80% reduction, 50% reduction, and 100% reduction).

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 26, 2017
• Study Start: April 3, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)