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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | 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) | 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). |
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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:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ralf M Nass, MD | University of Virginia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States | ||
| University of Virginia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41651803 | Result | 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. |
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Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
Data will be made available after the primary publications of each study.
The Data Sharing Agreements will be formulated by the study team.
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Enrollment was defined when the ICF was signed by participant & study team. Once screening & training were completed, participants began a 2-wk at home use of a blinded CGM. Participants were asked to follow their UC without changes in their insulin parameters. CGM equipment was returned to the study team to facilitate downloading the data from the CGM, which must have been used 10 out of 14 days & a day must contain 70% measurements to be counted.
39 participants signed consent at two clinical sites between Nov 2023 - Sept 2024. Nine did not pass screening or withdrew prior to randomization; two participants dropped after randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | percentage points | From baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks) |
|
17 weeks - Adverse event reporting was initiated at visit 4 and concluded at visit 10
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Breton, PhD | UVA Center for Diabetes Technology | 434-982-6484 | marc.breton@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 19, 2024 | Aug 15, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2024 | Aug 15, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 6, 2024 | Oct 4, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Multi-center, randomized, parallel group, active-comparator clinical trial of CGM based titration of insulin Degludec vs. standard titration by SMBG.
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| From baseline (week -2-0) to week 14-16 |
| 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). | From baseline (week -2-0) to week 14-16 |
| 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). | From baseline (week -2-0) to week 14-16 |
| Change in Mean Glucose Level | 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 (%) | 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) | 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) | 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 | The investigator changes the dose from baseline to week 16 | From week 0 to week 16 |
| 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. | From week 0 to week 16 |
| Charlottesville |
| Virginia |
| 22903 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| OG001 | 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. |
|
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| Secondary | Change in HbA1c | Percent change in HbA1c measured as percentage | Posted | Mean | Standard Deviation | percentage | From week 0 to week 16 |
|
|
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| Secondary | 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). | Posted | Mean | Standard Deviation | percentage points | From baseline (week -2-0) to week 14-16 |
|
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| Secondary | 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). | Posted | Mean | Standard Deviation | percentage points | From baseline (week -2-0) to week 14-16 |
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| Secondary | 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). | Posted | Mean | Standard Deviation | percentage points | From baseline (week -2-0) to week 14-16 |
|
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| Secondary | Change in Mean Glucose Level | The average CGM-measured blood glucose level (mg/dL). | Posted | Mean | Standard Deviation | mg/dL | From baseline (week -2-0) to week 14-16 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage points | From baseline (week -2-0) to week 14-16 |
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|
| Secondary | 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). | Posted | Mean | Standard Deviation | percentage points | From baseline (week -2-0) to week 14-16 |
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| Secondary | 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). | Posted | Mean | Standard Deviation | percentage points | From baseline (week -2-0) to week 14-16 |
|
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| Secondary | Basal Insulin Dose Changes | The investigator changes the dose from baseline to week 16 | Posted | Geometric Mean | Geometric Coefficient of Variation | Units | From week 0 to week 16 |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | %-point | From week 0 to week 16 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |