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

February 11, 2026 updated by: Marc Breton, University of Virginia

An Exploratory 16-Week Pilot Study of the Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin, With or Without Non-Insulin Antidiabetic Drugs, in Type 2 Diabetes Mellitus Participants Treated With Basal Insulin.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an 18-week study designed to investigate the effect of a continuous glucose monitor (CGM) based titration algorithm versus a standard titration by self-monitoring blood glucose (SMBG) on glycemic control in Type 2 Diabetes (T2DM) participants using insulin Degludec. After 2 weeks of blinded CGM baseline observation, participants are randomized 2:1 to CGM-based titration or standard titration by SMBG for 16 weeks. In the SMBG group, all titrated doses will be reviewed by a study physician prior to use and participants will wear a blinded CGM during the whole study. After completion of the 16-week titration, participants are followed up for 2 days. Participants will be divided related to use of sulfonylureas or glinides with a maximum cap of nine participants being treated with sulfonylureas and glinides to complete the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 years or older at signing of informed consent
  2. Diagnosis of Type 2 Diabetes minimum 180 days before the day of screening
  3. Hemoglobin A1c between 7-9% and measured by local lab at screening
  4. On daily basal insulin for at least 90 days before inclusion into the study

  5. Stable dose of oral and injectable (other than insulin) antidiabetic medications for 90 days prior inclusion. Acceptable medications include:

    1. Metformin
    2. Sulfonylureas
    3. Meglitinides (glinides)
    4. Dipeptidyl peptidase 4 (DPP-4) inhibitors
    5. Sodium glucose co-transporter 2 (SGLT2) inhibitors
    6. Thiazolidinediones
    7. Alpha-glucosidase inhibitors
    8. Oral combination products (for the allowed individual oral anti-diabetic drugs)
    9. Oral or injectable Glucagon-like peptide-1 (GLP-1) Receptor Agonists (RAs)
    10. If on sulfonylureas or glinides, willingness to reduce dose by 50%

Exclusion Criteria

  1. Hypersensitivity to Degludec
  2. Use of an insulin pump
  3. Use of a short-acting insulin
  4. Participation or has participated in another trial within 90 days of the screening visit
  5. Female who is pregnant or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method
  6. Any disorder, except for conditions associated with T2D, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
  7. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days of the screening visit
  8. Known skin reactions to CGM adhesives
  9. Current/prior use of CGM within 30 days of the screening visit
  10. Any planned surgery or procedures where basal insulin would be decreased or held in anticipation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Continuous Glucose Monitoring (CGM) based Titration
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
A Continuous Glucose Monitoring (CGM)-based once weekly titration algorithm of basal insulin as implemented in DiAs Cloud platform
Other Names:
  • Degludec
No Intervention: Standard Self-Monitoring Blood Glucose (SMBG) Titration
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Time in Range 3.9-10.0 mmol/L (70-180 mg/dL)
Time Frame: From baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: From week 0 to week 16
Percent change in HbA1c measured as percentage
From week 0 to week 16
Change in Time in Tight Range 3.9-7.8 mmol/L (70-140 mg/dL)
Time Frame: From baseline (week -2-0) to week 14-16
Percent change in time in tight range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TITR = TITR (weeks 14-16) - TITR (baseline).
From baseline (week -2-0) to week 14-16
Change in Time Above 10.0 mmol/L (180 mg/dL)
Time Frame: From baseline (week -2-0) to week 14-16
Percent of time spent above 10.0 mmol/L (180 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TAR = TAR (weeks 14-16) - TAR (baseline).
From baseline (week -2-0) to week 14-16
Change in Time Above 13.9 mmol/L (250 mg/dL)
Time Frame: From baseline (week -2-0) to week 14-16
Percent of time spent above (TAR2) 13.9 mmol/L (250 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TAR2 = TAR2 (weeks 14-16) - TAR2 (baseline).
From baseline (week -2-0) to week 14-16
Change in Mean Glucose Level
Time Frame: From baseline (week -2-0) to week 14-16
The average CGM-measured blood glucose level (mg/dL).
From baseline (week -2-0) to week 14-16
Change in Continuous Glucose Monitoring Coefficient of Variation (%)
Time Frame: From baseline (week -2-0) to week 14-16
The statistical measure (%) of the relative dispersion of data points in a data series around the average CGM-measured blood glucose level.
From baseline (week -2-0) to week 14-16
Change in Time Below 3.9 mmol/L (70 mg/dL)
Time Frame: From baseline (week -2-0) to week 14-16
Percent of time spent below (TBR) 3.9 mmol/L (70 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TBR = TBR (weeks 14-16) - TBR (baseline).
From baseline (week -2-0) to week 14-16
Change in Time Below 3.0 mmol/L (54 mg/dL)
Time Frame: From baseline (week -2-0) to week 14-16
Percent of time spent below (TBR2) 3.0 mmol/L (54 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TBR2 = TBR2 (weeks 14-16) - TBR2 (baseline).
From baseline (week -2-0) to week 14-16
Basal Insulin Dose Changes
Time Frame: From week 0 to week 16
The investigator changes the dose from baseline to week 16
From week 0 to week 16
Percent Acceptance Rate
Time Frame: From week 0 to week 16
Investigator acceptance rate of weekly dose guidance from Experimental arm only. Measure is calculated for each participant as 100x(number of accepted doses)/(number of recommended doses). Median and IQR is reported.
From week 0 to week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ralf M Nass, MD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 230357

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.

IPD Sharing Time Frame

Data will be made available after the primary publications of each study.

IPD Sharing Access Criteria

The Data Sharing Agreements will be formulated by the study team.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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