Diabetes
Conditions
Keywords
Uncontrolled Type 2 Diabetes, Insulclock, Electronic device, Alarm system
Brief summary
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.
Detailed description
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.
Interventions
DEVICEInsulclock with feedback
Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
DEVICEInsulclock without feedback
Not feedback on insulin administration.
Sponsors
Insulcloud S.L.
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
At midpoint (week 12), patients will be converted to the alternate arm (cross-over design).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 to 80 years * Diagnosis of T2D * Screening HbA1c ≥ 7.5% to ≤ 11% * Continuous treatment with one or more oral antidiabetic agents, for at least 2 months * Continuous treatment with daily basal insulin (NPH, glargine U100 or detemir), for at least 2 months, (insulin dose ≤0.5U/Kg/day) * If patients are on combination therapy of basal insulin and GLP1-RA, the dose of GLP-1 RA should be stable for the past three months. * Owns a smartphone - Apple iPhone, Samsung Galaxy models * Signed, informed consent and HIPAA documentation * Subjects' ability to self-administer insulin, use the device and complete subject reported outcomes instruments * Subjects' ability & willingness to adhere to and be compliant with study protocol
Exclusion criteria
* Refusal or inability to give informed consent to participate in the study * Subject is currently taking or was treated with glargine U300 insulin, degludec, insulin dose greater than 0.5 U/kg/day during the previous three months * Subject treated with prandial insulin or premixed formulations during the previous three months * Impaired renal function as shown by, but not limited to, eGFR \< 30 ml/min. * Muscle weakness or hemiparesis related to previous stroke or myelopathy resulting in incoordination, muscle weakness and inability to use pen device for insulin administration * History of diabetic ketoacidosis during the previous 6 months * Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times the upper limit of the normal range * History of hypoglycemia unawareness * Pregnancy or lactation * Known hypersensitivity to insulin glargine or any of the components * Any malignancy within the last 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ * Current drug addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years * Diagnosis of dementia * Severe gastrointestinal diseases including gastroparesis * Cardiac status NYHA III-IV * Acute infection * Patients on or planning to receive long term oral or injectable steroid treatment for greater than 10 days * Patient schedule to undergo general surgery during the next 6 months * Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Insulin Injection Irregularities. | Week 0 through week 24. | 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. |
| Number of Participants Experiencing Insulclock Device Malfunctions | Up to 12 weeks | Number of participants experiencing Insulclock device malfunctions are reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean HbA1c. | Baseline, 24 weeks | 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. |
| Number of Episodes of Hypoglycemia. | Week 0 through week 24. | 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). |
| Number of Episodes of Severe Hypoglycemia. | Week 0 through week 24. | 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. |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score. | Baseline, 24 weeks | 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. |
| Change in 7-point Self Monitoring of Blood Glucose (SMBG) Profile. | 3 to 5 days prior to randomization, up to 24 weeks. | 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. |
| Change in Diabetes Quality of Life Clinical Trial Questionnaire-Revised (DQLCTQ-R) Score | Baseline, 24 weeks. | 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. |
| Change in Daily Fasting Glucose Profile Averages. | Week 0 through week 24. | Daily fasting glucose profile averages will be recorded to monitor glycemic control. |
| Change in Diabetes Related Quality of Life (DRQoL) Scores. | Baseline, 24 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 40 |
| 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. | 11 |
| 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. | 7 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Main Study | Lost to Follow-up | 5 | 5 |
Baseline characteristics
| Characteristic | Insulclock With Feedback (Group A) | Insulclock Without Feedback (Group B) | Pilot: Insulclock With Feedback (Group A) | Pilot:Insulclock Without Feedback (Group B) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 0 Participants | 0 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 35 Participants | 11 Participants | 7 Participants | 88 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants | 37 Participants | 11 Participants | 6 Participants | 90 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 4 Participants |
| Region of Enrollment United States | 40 participants | 40 participants | 11 participants | 7 participants | 98 participants |
| Sex: Female, Male Main study phase Female | 27 Participants | 17 Participants | 6 Participants | 3 Participants | 53 Participants |
| Sex: Female, Male Main study phase Male | 13 Participants | 23 Participants | 5 Participants | 4 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 11 | 0 / 7 |
| other Total, other adverse events | 8 / 40 | 13 / 40 | 0 / 11 | 0 / 7 |
| serious Total, serious adverse events | 1 / 40 | 4 / 40 | 0 / 11 | 0 / 7 |
Outcome results
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.
Time frame: Week 0 through week 24.
Population: Data were collected as a part of main phase of the study only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulclock With Feedback (Group A) | Number of Insulin Injection Irregularities. | 22.22 irregularities | Standard Deviation 25.12 |
| Insulclock Without Feedback (Group B) | Number of Insulin Injection Irregularities. | 23.10 irregularities | Standard Deviation 26.75 |
Primary
Number of Participants Experiencing Insulclock Device Malfunctions
Number of participants experiencing Insulclock device malfunctions are reported
Time frame: Up to 12 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot: Insulclock With Feedback (Group A) | Number of Participants Experiencing Insulclock Device Malfunctions | 5 Participants |
| Pilot: Insulclock Without Feedback (Group B) | Number of Participants Experiencing Insulclock Device Malfunctions | 2 Participants |
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.
Time frame: 3 to 5 days prior to randomization, up to 24 weeks.
Population: 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.
Secondary
Change in Daily Fasting Glucose Profile Averages.
Daily fasting glucose profile averages will be recorded to monitor glycemic control.
Time frame: Week 0 through week 24.
Population: Data were collected as a part of main phase of the study only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulclock With Feedback (Group A) | Change in Daily Fasting Glucose Profile Averages. | 142.24 mg/dL | Standard Deviation 32 |
| Insulclock Without Feedback (Group B) | Change in Daily Fasting Glucose Profile Averages. | 146.54 mg/dL | Standard Deviation 39 |
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.
Time frame: Baseline, 24 weeks.
Population: 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.
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.
Time frame: Baseline, 24 weeks
Population: 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.
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.
Time frame: Baseline, 24 weeks
Population: Data were collected as a part of main phase of the study only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulclock With Feedback (Group A) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score. | 15.45 score on a scale | Standard Deviation 3.7 |
| Insulclock Without Feedback (Group B) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score. | 15.18 score on a scale | Standard Deviation 3.05 |
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.
Time frame: Baseline, 24 weeks
Population: Data were collected as a part of main phase of the study only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulclock With Feedback (Group A) | Change in Mean HbA1c. | -0.9 mg/dL | Standard Deviation 2.02 |
| Insulclock Without Feedback (Group B) | Change in Mean HbA1c. | -0.73 mg/dL | Standard Deviation 2 |
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).
Time frame: Week 0 through week 24.
Population: Data were collected as a part of main phase of the study only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulclock With Feedback (Group A) | Number of Episodes of Hypoglycemia. | 29 number of events |
| Insulclock Without Feedback (Group B) | Number of Episodes of Hypoglycemia. | 25 number of events |
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.
Time frame: Week 0 through week 24.
Population: Data were collected as a part of main phase of the study only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulclock With Feedback (Group A) | Number of Episodes of Severe Hypoglycemia. | 1 number of events |
| Insulclock Without Feedback (Group B) | Number of Episodes of Severe Hypoglycemia. | 1 number of events |