Trial · NCT02910089
ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus
NCT02910089, Phase 4, Completed, AstraZeneca; results first posted 2019-08-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus. Trials, record NCT02910089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02910089
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus
- NCT number
- NCT02910089
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,400 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Shared Decision Making
- First posted
- 2016-09-21
- Last updated
- 2019-09-17
- Results first posted
- 2019-08-29
- Limitations and caveats
Evaluation of glycemic control is limited to participants who had baseline labs available. \~29% had missing outcomes data for the primary outcome; while we used multiple imputation to evaluate the study, this could have influenced the findings.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Glycosylated Hemoglobin (HbA1c): | baseline and at the end of 12 months post index date | Pre- to post-intervention change in mean HbA1c levels |
| Secondary | Medication Adherence (PDC Measure) | during follow-up period of 12 months post index date | Mean Adherence (PDC) in each study arm in the follow-up period |
| Secondary | Percentage (Proportion x 100) of Patients Achieving Optimal Adherence | during follow-up period of 12 months post index date | Percentage (Proportion x 100) of patients in each study arm achieving optimal adherence (PDC ≥0.80) in the follow-up period |
| Secondary | Patients Achieving HbA1c | baseline and at the end of 12 months post index date | Percentage (Proportion x 100) of patients in each study arm achieving optimal HbA1c control in the follow-up period |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Glycosylated Hemoglobin (HbA1c): | baseline and at the end of 12 months post index date | Full Analysis Set | Percentage of HbA1c | MEAN |
| SECONDARY | Medication Adherence (PDC Measure) | during follow-up period of 12 months post index date | Full Analysis Set | Percentage of Days | MEAN |
| SECONDARY | Percentage (Proportion x 100) of Patients Achieving Optimal Adherence | during follow-up period of 12 months post index date | Full Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Patients Achieving HbA1c | baseline and at the end of 12 months post index date | Full Analysis Set | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Glycosylated Hemoglobin (HbA1c): | Shared Decision Making/Brief Negotiated Interviewing | -0.75 | Standard Deviation 1.96 | Percentage of HbA1c | |
| Glycosylated Hemoglobin (HbA1c): | Control Arm | -0.79 | Standard Deviation 2.01 | Percentage of HbA1c | |
| Medication Adherence (PDC Measure) | Shared Decision Making/Brief Negotiated Interviewing | 67.5 | Standard Deviation 31.6 | Percentage of Days | |
| Medication Adherence (PDC Measure) | Control Arm | 66.2 | Standard Deviation 32.7 | Percentage of Days | |
| Percentage (Proportion x 100) of Patients Achieving Optimal Adherence | Shared Decision Making/Brief Negotiated Interviewing | 46.2 | Percentage of Participants | ||
| Percentage (Proportion x 100) of Patients Achieving Optimal Adherence | Control Arm | 45.0 | Percentage of Participants | ||
| Patients Achieving HbA1c | Shared Decision Making/Brief Negotiated Interviewing | 34.8 | Percentage of Participants | ||
| Patients Achieving HbA1c | Control Arm | 38.0 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Shared Decision Making/Brief Negotiated Interviewing | 700 | |
| Overall Study | STARTED | Control Arm | 700 | |
| Overall Study | COMPLETED | Shared Decision Making/Brief Negotiated Interviewing | 678 | |
| Overall Study | COMPLETED | Control Arm | 684 | |
| Overall Study | NOT COMPLETED | Shared Decision Making/Brief Negotiated Interviewing | 22 | |
| Overall Study | NOT COMPLETED | Control Arm | 16 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypoglycemia | Metabolism and nutrition disorders | Shared Decision Making/Brief Negotiated Interviewing | 1 | 678 | 1 |
| other | Hypoglycemia | Metabolism and nutrition disorders | Control Arm | 0 | 684 | 0 |
| serious | Constipation | Gastrointestinal disorders | Shared Decision Making/Brief Negotiated Interviewing | 1 | 678 | 1 |
| serious | Constipation | Gastrointestinal disorders | Control Arm | 0 | 684 | 0 |
| serious | Diarrhea | Gastrointestinal disorders | Shared Decision Making/Brief Negotiated Interviewing | 1 | 678 | 1 |
| serious | Diarrhea | Gastrointestinal disorders | Control Arm | 0 | 684 | 0 |
| serious | Fatigue | General disorders | Shared Decision Making/Brief Negotiated Interviewing | 1 | 678 | 1 |
| serious | Fatigue | General disorders | Control Arm | 0 | 684 | 0 |
| serious | Hypoglycemia | Metabolism and nutrition disorders | Shared Decision Making/Brief Negotiated Interviewing | 1 | 678 | 3 |
| serious | Hypoglycemia | Metabolism and nutrition disorders | Control Arm | 0 | 684 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Shared Decision Making/Brief Negotiated Interviewing | 0 | 678 |
| Total, all-cause mortality | Control Arm | 0 | 684 |
| Total, other adverse events | Shared Decision Making/Brief Negotiated Interviewing | 1 | 678 |
| Total, other adverse events | Control Arm | 0 | 684 |
| Total, serious adverse events | Shared Decision Making/Brief Negotiated Interviewing | 5 | 678 |
| Total, serious adverse events | Control Arm | 0 | 684 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30939143 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Shared Decision Making/Brief Negotiated Interviewing vs Control Arm: deaths from any cause | Trial comparisons |
| Shared Decision Making/Brief Negotiated Interviewing vs Control Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02910089
GET https://conductscience.org/api/trials/v1/NCT02910089/registered