The Efficacy of Multiple Daily Injection Treatment With an Optimization Algorithm Adjusting Basal-Bolus Parameters in Free-Living Outpatient Conditions in Adults With Type 1 Diabetes

Overview

The Artificial Pancreas lab at McGill University has developed an optimization algorithm for adults with Type 1 Diabetes (T1D) on Multiple Daily Injection (MDI) therapy with the adjunctive use of glucose sensor technology, collectively known as sensor-augmented MDI therapy. The algorithm is designed to estimate optimal basal-bolus parameters based on the patient's glucose, insulin and meal data over several days. The investigators hope that this algorithm will be better able to improve long-term glycemic targets by reducing HbA1c levels compared to sensor-augmented MDI therapy alone.

Full Title of Study: “An Open-Label, Randomized, Two-Way, Parallel Study to Compare the Efficacy of Multiple Daily Injection Treatment With an Insulin Dose Optimization Algorithm in Free-Living Outpatient Conditions in Patients With Type 1 Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 1, 2021

Detailed Description

The objective of this exploratory study is to test the efficacy of this optimization algorithm with sensor-augmented MDI therapy in improving long-term glucose control, using a randomized parallel study over three months. The optimization algorithm may lead to the automation of physician-adjusted basal rate and Insulin to Carb Ratio (ICR) adjustments.

84 adults with type 1 diabetes will be enrolled in the study, where they will randomly undergo one of two interventions:

1. Sensor-Augmented MDI Therapy: Participants will undergo their usual MDI therapy along with a Freestyle Libre glucose sensor (Abbott Diabetes Care), and a data collection mobile application that collects insulin and meal data.

2. Sensor-Augmented MDI Therapy with the Optimization Algorithm: Participants will undergo MDI therapy with a Freestyle Libre glucose sensor (Abbott Diabetes Care) and a data collection mobile application that collects insulin and meal data. Every week, participants will have their insulin doses adjusted by the optimization algorithm's recommendations.

Interventions

  • Other: MDI (multiple daily injections) with Optimization Algorithm
    • Multiple daily injections (MDI) (slow acting insulin and Rapid acting insulin) therapy involves four or more daily insulin injections. Once or twice daily, a long acting insulin is injected as a basal dose. These long acting insulins are designed to dissipate slowly and evenly into the bloodstream for 24 to 36 hours following injection. This basal injection aims to mimic the physiological healthy basal insulin released from a healthy pancreas all day. Furthermore, multiple insulin bolus doses are injected at every meal each day using rapid or short acting insulin. These injections are administered before meals and are calculated using patients’ ICRs and meal carbohydrate quantities.

Arms, Groups and Cohorts

  • No Intervention: Sensor-Augmented MDI Therapy
    • Participants will undergo their usual multiple daily injection (MDI) therapy along with a Freestyle Libre glucose sensor (Abbott Diabetes Care), and a data collection mobile application that collects insulin and meal data.
  • Experimental: MDI with Basal-Bolus Optimization Algorithm
    • Participants will undergo multiple daily injection (MDI) therapy with a Freestyle Libre glucose sensor (Abbott Diabetes Care) and a data collection mobile application that collects insulin and meal data. Every week, participants’ insulin doses will be updated by the optimization algorithm’s recommendations.

Clinical Trial Outcome Measures

Primary Measures

  • Change in HbA1c levels
    • Time Frame: 3 months
    • Difference in HbA1c levels from the start to the end of the study

Secondary Measures

  • 1. Percentage of time of sensor glucose levels spent:
    • Time Frame: Through the last 7 days of study completion
    • a. between 3.9 and 7.8 mmol/L; b.between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d.below 3.3 mmol/L; e.below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
  • 2. Percentage of overnight time (23:00-7:00) of sensor glucose levels:
    • Time Frame: Through the last 7 days of study completion
    • a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c.below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
  • 3. Percentage of daytime (7:00-23:00) of sensor glucose levels:
    • Time Frame: Through the last 7 days of study completion
    • a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
  • 4. Standard deviation of glucose levels.
    • Time Frame: Through the last 7 days of study completion
    • Standard deviation of glucose levels as a measure of glucose variability.
  • 5. Total insulin delivery.
    • Time Frame: Through the last 7 days of study completion
    • Total insulin delivery
  • 6. Mean sensor glucose level during:
    • Time Frame: Through the last 7 days of study completion
    • a. the overall study period; b. the daytime period; c. overnight period.

Participating in This Clinical Trial

Inclusion Criteria

1. Males and females ≥ 18 years of age

2. Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.

3. Undergoing multiple daily injection therapy.

4. HbA1c ≥ 8% in the last 2 months.

Exclusion Criteria

1. Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

2. Failure to comply with the study protocol or with team's recommendations.

3. Injection of isophane insulin (NPH) or any intermediate-acting insulin

4. Current or ≤ 1 month use of other antihyperglycemic agents (Sodium-Glucose Co-transporter 2 inhibitor (SGLT2), Glucagon-Like Peptide-1 (GLP-1), Metformin, Acarbose, etc.…).

5. Pregnancy

6. Severe diabetic ketoacidosis episode within one month of admission

7. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator

8. Recent (<6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery

9. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • McGill University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Emilie Palisaitis, B.Sc., MEng., +1 (514) 553-5500, emilie.palisaitis@mcgill.ca

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