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Completed

NCT Number: NCT06111508

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

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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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%

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

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

Other names: Degludec

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in HbA1c

    Time frame: From week 0 to week 16

    Percent change in HbA1c measured as percentage

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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.

  7. 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).

  8. 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).

  9. Basal Insulin Dose Changes

    Time frame: From week 0 to week 16

    The investigator changes the dose from baseline to week 16

  10. 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.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study 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.

Acronym: CGM-DTx

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2023
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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