The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Participants.

NCT06111508 | Completed Results DMC FDA Device

• 1 other identifier: 230357
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to compare the effect of a continuous glucose monitor (CGM) based titration algorithm to standard titration by self-monitoring blood glucose (SMBG) in participants with Type 2 Diabetes already using long acting insulin. The comparison aims to study the difference in glycemic control between the two therapies. Participants will be followed for 18 weeks and will be provided with Degludec insulin, insulin pen, and a CGM (Dexcom G6).

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Continuous Glucose Monitoring (CGM); Degludec Insulin; Self-monitoring blood glucose (SMBG)

Outcome Measures

Primary Outcomes (1)

• Change in Time in Range 3.9-10.0 mmol/L (70-180 mg/dL)

  Change in CGM-measured time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TIR = TIR (weeks 14-16) - TIR (baseline). Change in TIR is measured with percentage points as TIR is measured with the percentage time spent within the range 3.9-10.0 mmol/L (70-180 mg/dL).

  From baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks)

Secondary Outcomes (10)

• Change in HbA1c

  From week 0 to week 16

• Change in Time in Tight Range 3.9-7.8 mmol/L (70-140 mg/dL)

  From baseline (week -2-0) to week 14-16

• Change in Time Above 10.0 mmol/L (180 mg/dL)

  From baseline (week -2-0) to week 14-16

• Change in Time Above 13.9 mmol/L (250 mg/dL)

  From baseline (week -2-0) to week 14-16

• Change in Mean Glucose Level

  From baseline (week -2-0) to week 14-16

Study Arms (2)

Continuous Glucose Monitoring (CGM) based Titration

EXPERIMENTAL

The CGM-based titration algorithm will run on the Diabetes Assistant and Amazon Web Services (AWS) platform (DiAs-Cloud). DiAs-Cloud enables the seamless integration of a smart phone application and AWS server architecture to enable data capture, dose computation, review by the clinical team, and communication to study participants. For dose computation the algorithm is comprised of three components; titration glucose level, personalized target, and safety hypoglycemia feature.

Device: Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs

Standard Self-Monitoring Blood Glucose (SMBG) Titration

NO INTERVENTION

The SMBG-based titration algorithm will run on the Diabetes Assistant and Amazon Web Services (AWS) platform (DiAs-Cloud). DiAs-Cloud enables the seamless integration of a smart phone application and AWS server architecture to enable data capture, dose computation, review by the clinical team, and communication to study participants. Participants in the standard SMBG based titration group will wear a blinded CGM during the whole study. The total daily basal insulin dose will be converted 1:1 to Degludec. Algorithm informed dose changes will be made once weekly and checked by study physician.

Interventions

Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs DEVICE

A Continuous Glucose Monitoring (CGM)-based once weekly titration algorithm of basal insulin as implemented in DiAs Cloud platform

Also known as: Degludec

Continuous Glucose Monitoring (CGM) based Titration

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older at signing of informed consent
• Diagnosis of Type 2 Diabetes minimum 180 days before the day of screening
• Hemoglobin A1c between 7-9% and measured by local lab at screening
• Metformin
• Sulfonylureas
• Meglitinides (glinides)
• Dipeptidyl peptidase 4 (DPP-4) inhibitors
• Sodium glucose co-transporter 2 (SGLT2) inhibitors
• Thiazolidinediones
• Alpha-glucosidase inhibitors
• Oral combination products (for the allowed individual oral anti-diabetic drugs)
• Oral or injectable Glucagon-like peptide-1 (GLP-1) Receptor Agonists (RAs)
• If on sulfonylureas or glinides, willingness to reduce dose by 50%

You may not qualify if:

• Hypersensitivity to Degludec
• Use of an insulin pump
• Use of a short-acting insulin
• Participation or has participated in another trial within 90 days of the screening visit
• Female who is pregnant or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method
• Any disorder, except for conditions associated with T2D, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
• Known skin reactions to CGM adhesives
• Current/prior use of CGM within 30 days of the screening visit
• Any planned surgery or procedures where basal insulin would be decreased or held in anticipation

Sponsors & Collaborators

• University of Virginia: lead
• Novo Nordisk A/S: collaborator

Study Sites (2)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• El Fathi A, Nass R, Levy CJ, Levister C, O'Malley G, Shah NA, Hassan S, Quainoo C, Koravi CLK, Nguyen TN, Santini GM, Emory E, Alix C, Flanagan DK, Fulkerson D, Clancy Oliveri M, Laugesen C, Lindelov JK, Hansen PW, Breton MD. Safety and Feasibility of Algorithmic Continuous Glucose Monitoring-Based Titration in People with Type 2 Diabetes Using Insulin Degludec, With or Without Noninsulin Glucose-Lowering Drugs: A 16-Week Randomized Controlled Trial. Diabetes Technol Ther. 2026 Feb 6:15209156261420193. doi: 10.1177/15209156261420193. Online ahead of print.

  PMID: 41651803 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Marc Breton, PhD
• Organization: UVA Center for Diabetes Technology

marc.breton@virginia.edu

434-982-6484

Study Officials

• Ralf M Nass, MD

  University of Virginia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multi-center, randomized, parallel group, active-comparator clinical trial of CGM based titration of insulin Degludec vs. standard titration by SMBG.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: November 29, 2023
• Primary Completion: September 13, 2024
• Study Completion: September 16, 2024
• Last Updated: March 4, 2026
• Results First Posted: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available after the primary publications of each study.
• Access Criteria: The Data Sharing Agreements will be formulated by the study team.

Locations

US (2)