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| Name | Class |
|---|---|
| Insulcloud S.L. | INDUSTRY |
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Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of Insulclock® - small electronic device to help track date, time and dosage of the last injection, type of insulin used and temperature, with an alarm system to prevent insulin omissions and mistiming.
Diabetes is arguably the most urgent healthcare challenge of the 21st century. Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of Insulclock® - small electronic device to help track date, time and dosage of the last injection, type of insulin used and temperature, with an alarm system to prevent insulin omissions and mistiming. The Insulclock's real time memory and alert system are likely to improve treatment adherence, patient's satisfaction, and quality of life measures, which may improve glycemic control in insulin treated patients with Type 2 Diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulclock with feedback (Group A) | Experimental | Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm. |
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| Insulclock without feedback (Group B) | Active Comparator | Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulclock with feedback | Device | Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Insulin Injection Irregularities. | Number of insulin injection irregularities (omission, mistiming and dosing) will be registered on the Insulclock device, and data will be retrieved during each clinic visit to monitor treatment adherence. | Week 0 through week 24. |
| Number of Participants Experiencing Insulclock Device Malfunctions | Number of participants experiencing Insulclock device malfunctions are reported | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score. | The amplitude of the score on the DTSQc gives the degree of change in satisfaction while the direction (positive or negative) will provide guidance on the preference of one device over the other. DTSQc contains eight items scored on 7-point scales; scores range from +3 = much more satisfied now to -3 = much less satisfied now, with 0 (midpoint), representing no change. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Umpierrez, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Clinic, Emory University Hospital (non-CRN), Emory University Hospital Clinical Research Network, Emory University Hospital Midtown, Grady Health System (non-CRN) | Atlanta | Georgia | 30322 | United States |
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The study consented 121 participants. The study team realized that changes needed to be done for the protocol to be efficient. The first 28 candidates were consented for "pilot" data, ten of them were screen failures, 18 were randomized. Data on Insulclock device malfunctions were collected, it was planned to improve all issues by the time the main phase of the study started. 93 subjects were consented for the main study, 13 were screen failures, and 80 subjects were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulclock With Feedback (Group A) | Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm. Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. |
| FG001 | Insulclock Without Feedback (Group B) | Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm. Insulclock without feedback: Not feedback on insulin administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study |
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| Pilot |
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulclock With Feedback (Group A) | Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm. Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Insulin Injection Irregularities. | Number of insulin injection irregularities (omission, mistiming and dosing) will be registered on the Insulclock device, and data will be retrieved during each clinic visit to monitor treatment adherence. | Data were collected as a part of main phase of the study only. | Posted | Mean | Standard Deviation | irregularities | Week 0 through week 24. |
|
24 weeks
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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 | Insulclock With Feedback (Group A) | Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm. Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Umpierrez | Emory University | 404-251-8957 | geumpie@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2018 | Sep 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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At midpoint (week 12), patients will be converted to the alternate arm (cross-over design).
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| Insulclock without feedback | Device | Not feedback on insulin administration. |
|
| Baseline, 24 weeks |
| Change in Diabetes Related Quality of Life (DRQoL) Scores. | DRQoL is a composite score, consisting of a standardized and unweighted Insulin Treatment Experience Questionnaire Score (ITEQ), and Problem Areas in Diabetes (PAID) questionnaire score. ITEQ includes 7 domains: leisure activities (4 items), psychological barriers (2 items), handling (5 items), diabetes control (6 items), dependence (5 items), weight control (3 items), sleep (2 items); + 1 additional item assigned to assess overall satisfaction with current insulin therapy regimen. The PAID contains 20 items that describe negative emotions related to diabetes commonly experienced by patients with diabetes. Each question has five possible answers with a value from 0 to 4, with 0 representing "no problem" and 4 "a serious problem". The scores are added up and multiplied by 1.25, generating a total score between 0 - 100. | Baseline, 24 weeks |
| Change in Mean HbA1c. | HbA1c is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration. The test is limited to a three-month average because the lifespan of a red blood cell is four months (120 days). Change in mean HbA1cas will be measure and recorded to monitor glycemic control. | Baseline, 24 weeks |
| Number of Episodes of Hypoglycemia. | Number of episodes of hypoglycemia will be recorded. For this study, symptomatic hypoglycemia is defined as an event with typical symptoms (i.e., sweating, palpitation, and feeling of hunger) with or without confirmation by plasma glucose <54 mg/dl (3.9 mmol/L). | Week 0 through week 24. |
| Number of Episodes of Severe Hypoglycemia. | Number of episodes of severe hypoglycemia will be recorded.Severe hypoglycemia is defined as episodes necessitating assistance and associated with measured plasma glucose < 40 mg/dl (2.2 mmol/L), or with prompt recovery after administration of carbohydrates, glucagon, or other resuscitative actions. | Week 0 through week 24. |
| Change in Daily Fasting Glucose Profile Averages. | Daily fasting glucose profile averages will be recorded to monitor glycemic control. | Week 0 through week 24. |
| Change in 7-point Self Monitoring of Blood Glucose (SMBG) Profile. | SMBG refers to home blood glucose testing for people with diabetes. 7-point SMBG profile include fasting, before meals, 2 hours after meals, and bedtime. | 3 to 5 days prior to randomization, up to 24 weeks. |
| Change in Diabetes Quality of Life Clinical Trial Questionnaire-Revised (DQLCTQ-R) Score | The DQLCTQ-R is a 57-item scale that comprises 8 dimensions: physical function, energy/fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility, and frequency of symptoms. | Baseline, 24 weeks. |
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| BG001 | Insulclock Without Feedback (Group B) | Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm. Insulclock without feedback: Not feedback on insulin administration. |
| BG002 | Pilot: Insulclock With Feedback (Group A) | Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device. |
| BG003 | Pilot:Insulclock Without Feedback (Group B) | Participants use the Insulclock, but will not receive feedback on insulin administration. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Insulclock Without Feedback (Group B) | Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm. Insulclock without feedback: Not feedback on insulin administration. |
| OG002 | Pilot: Insulclock With Feedback (Group A) | Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device. |
| OG003 | Pilot: Insulclock Without Feedback (Group B) | Participants use the Insulclock, but will not receive feedback on insulin administration. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device. |
|
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| Primary | Number of Participants Experiencing Insulclock Device Malfunctions | Number of participants experiencing Insulclock device malfunctions are reported | Data were collected as a part the pilot phase. Data on Insulclock device malfunctions were collected, it was planned to improve all issues by the time the main phase of the study started. | Posted | Count of Participants | Participants | Up to 12 weeks |
|
|
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| Secondary | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score. | The amplitude of the score on the DTSQc gives the degree of change in satisfaction while the direction (positive or negative) will provide guidance on the preference of one device over the other. DTSQc contains eight items scored on 7-point scales; scores range from +3 = much more satisfied now to -3 = much less satisfied now, with 0 (midpoint), representing no change. | Data were collected as a part of main phase of the study only. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 24 weeks |
|
|
|
| Secondary | Change in Diabetes Related Quality of Life (DRQoL) Scores. | DRQoL is a composite score, consisting of a standardized and unweighted Insulin Treatment Experience Questionnaire Score (ITEQ), and Problem Areas in Diabetes (PAID) questionnaire score. ITEQ includes 7 domains: leisure activities (4 items), psychological barriers (2 items), handling (5 items), diabetes control (6 items), dependence (5 items), weight control (3 items), sleep (2 items); + 1 additional item assigned to assess overall satisfaction with current insulin therapy regimen. The PAID contains 20 items that describe negative emotions related to diabetes commonly experienced by patients with diabetes. Each question has five possible answers with a value from 0 to 4, with 0 representing "no problem" and 4 "a serious problem". The scores are added up and multiplied by 1.25, generating a total score between 0 - 100. | The questionnaire was considered originally for use in the study, but no replies were received in a timely manner from the companies in charge of providing licensing for it. Therefore, data was not collected. | Posted | Baseline, 24 weeks |
|
|
| Secondary | Change in Mean HbA1c. | HbA1c is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration. The test is limited to a three-month average because the lifespan of a red blood cell is four months (120 days). Change in mean HbA1cas will be measure and recorded to monitor glycemic control. | Data were collected as a part of main phase of the study only. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 24 weeks |
|
|
|
| Secondary | Number of Episodes of Hypoglycemia. | Number of episodes of hypoglycemia will be recorded. For this study, symptomatic hypoglycemia is defined as an event with typical symptoms (i.e., sweating, palpitation, and feeling of hunger) with or without confirmation by plasma glucose <54 mg/dl (3.9 mmol/L). | Data were collected as a part of main phase of the study only. | Posted | Number | number of events | Week 0 through week 24. |
|
|
|
| Secondary | Number of Episodes of Severe Hypoglycemia. | Number of episodes of severe hypoglycemia will be recorded.Severe hypoglycemia is defined as episodes necessitating assistance and associated with measured plasma glucose < 40 mg/dl (2.2 mmol/L), or with prompt recovery after administration of carbohydrates, glucagon, or other resuscitative actions. | Data were collected as a part of main phase of the study only. | Posted | Number | number of events | Week 0 through week 24. |
|
|
|
| Secondary | Change in Daily Fasting Glucose Profile Averages. | Daily fasting glucose profile averages will be recorded to monitor glycemic control. | Data were collected as a part of main phase of the study only. | Posted | Mean | Standard Deviation | mg/dL | Week 0 through week 24. |
|
|
|
| Secondary | Change in 7-point Self Monitoring of Blood Glucose (SMBG) Profile. | SMBG refers to home blood glucose testing for people with diabetes. 7-point SMBG profile include fasting, before meals, 2 hours after meals, and bedtime. | Data was only collected at baseline, but not at other visits, therefore it was not possible to assess any change, and it was excluded from the analysis. | Posted | 3 to 5 days prior to randomization, up to 24 weeks. |
|
|
| Secondary | Change in Diabetes Quality of Life Clinical Trial Questionnaire-Revised (DQLCTQ-R) Score | The DQLCTQ-R is a 57-item scale that comprises 8 dimensions: physical function, energy/fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility, and frequency of symptoms. | The questionnaire was considered originally, but no replies were received in a timely manner from the company in charge of providing licensing for it. Therefore, data were not collected. | Posted | Baseline, 24 weeks. |
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| 0 |
| 40 |
| 1 |
| 40 |
| 8 |
| 40 |
| EG001 | Insulclock Without Feedback (Group B) | Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm. Insulclock without feedback: Not feedback on insulin administration. | 0 | 40 | 4 | 40 | 13 | 40 |
| EG002 | Pilot: Insulclock With Feedback (Group A) | Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Pilot: Insulclock Without Feedback (Group B) | Participants use the Insulclock, but will not receive feedback on insulin administration. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device. | 0 | 7 | 0 | 7 | 0 | 7 |
| Wound Infection | Infections and infestations | Non-systematic Assessment |
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| Heart Failure Readmission | Cardiac disorders | Non-systematic Assessment |
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| Surgical Procedures | Surgical and medical procedures | Non-systematic Assessment |
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| Nausea and vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Epigastric pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Hypoglicemia | Endocrine disorders | Non-systematic Assessment |
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| Toe injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Chest pain of muscular etiology | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Pain | General disorders | Non-systematic Assessment |
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| Leg swelling | General disorders | Non-systematic Assessment |
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| Non serious work related muscular injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Ear infection | Ear and labyrinth disorders | Non-systematic Assessment |
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| Abdominal pain | General disorders | Non-systematic Assessment |
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| CHF shortness of breath | Cardiac disorders | Non-systematic Assessment |
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| Diabetic neuropathy | Nervous system disorders | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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