AzTrials
AzTrials

Type 2 DiabetesCGM-DTxNCT06111508

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

A study testing Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs in people with Type 2 Diabetes, run by University of Virginia at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
29 Nov 2023to 16 Sep 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • On daily basal insulin for at least 90 days before inclusion into the study
  • Stable dose of oral and injectable (other than insulin) antidiabetic medications for 90 days prior inclusion. Acceptable medications include:
  • Metformin
Show all 15Show fewer
  • 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%

Who cannot join

  • 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.
Show all 10Show fewer
  • 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
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: 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).

Read the 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.

Conditions
Type 2 Diabetes
Being tested
Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs
Keywords
Type 2 Diabetes, Continuous Glucose Monitoring (CGM), Degludec Insulin, Self-monitoring blood glucose (SMBG)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAsDevice

    Also called Degludec

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

Study groups in NCT06111508
Study groupRoleWhat they receive
Continuous Glucose Monitoring (CGM) based TitrationExperimentalThe 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.
Receives: Device: Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs
Standard Self-Monitoring Blood Glucose (SMBG) TitrationNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (10)

  1. Change in HbA1c

    Percent change in HbA1c measured as percentage

    Measured: From week 0 to week 16

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

    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).

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

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

    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).

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

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

    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).

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

  5. Change in Mean Glucose Level

    The average CGM-measured blood glucose level (mg/dL).

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

  6. Change in Continuous Glucose Monitoring Coefficient of Variation (%)

    The statistical measure (%) of the relative dispersion of data points in a data series around the average CGM-measured blood glucose level.

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

  7. Change in Time Below 3.9 mmol/L (70 mg/dL)

    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).

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

  8. Change in Time Below 3.0 mmol/L (54 mg/dL)

    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).

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

  9. Basal Insulin Dose Changes

    The investigator changes the dose from baseline to week 16

    Measured: From week 0 to week 16

  10. Percent Acceptance Rate

    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.

    Measured: From week 0 to week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2023
  2. Study start29 Nov 2023
  3. Primary completion13 Sep 2024
  4. Study completion16 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multi-center, randomized, parallel group, active-comparator clinical trial of CGM based titration of insulin Degludec vs. standard titration by SMBG.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06111508
Sponsor's protocol ID
230357
Acronym
CGM-DTx
Status last verified
Feb 2026
First submitted
26 Oct 2023
Last updated
4 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.

Publications

  • 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 Aug;28(8):858-866. doi: 10.1177/15209156261420193. Epub 2026 Feb 6.

    PubMed 41651803

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs in people with Type 2 Diabetes, run by University of Virginia at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06111508, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in