A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes

Sponsor
Emory University (Other)
Overall Status
Completed
CT.gov ID
NCT03224234
Collaborator
Insulcoud S.L. (Other)
121
1
2
21.6
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Insulclock with feedback
  • Device: Insulclock without feedback
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
At midpoint (week 12), patients will be converted to the alternate arm (cross-over design).At midpoint (week 12), patients will be converted to the alternate arm (cross-over design).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes
Actual Study Start Date :
Nov 29, 2017
Actual Primary Completion Date :
Sep 18, 2019
Actual Study Completion Date :
Sep 18, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Device: Insulclock with feedback
Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.

Active Comparator: 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.

Device: Insulclock without feedback
Not feedback on insulin administration.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Number of Participants Experiencing Insulclock Device Malfunctions [Up to 12 weeks]

    Number of participants experiencing Insulclock device malfunctions are reported

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. Change in Daily Fasting Glucose Profile Averages. [Week 0 through week 24.]

    Daily fasting glucose profile averages will be recorded to monitor glycemic control.

  7. 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.

  8. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emory Clinic, Emory University Hospital (non-CRN), Emory University Hospital Clinical Research Network, Emory University Hospital Midtown, Grady Health System (non-CRN) Atlanta Georgia United States 30322

Sponsors and Collaborators

  • Emory University
  • Insulcoud S.L.

Investigators

  • Principal Investigator: Guillermo Umpierrez, MD, Emory University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Guillermo Umpierrez, MD, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier:
NCT03224234
Other Study ID Numbers:
  • IRB00094393
First Posted:
Jul 21, 2017
Last Update Posted:
Jan 22, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Guillermo Umpierrez, MD, Professor of Medicine, Emory University
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail 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.
Arm/Group Title Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B)
Arm/Group Description 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. 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.
Period Title: Main Study
STARTED 40 40
COMPLETED 35 35
NOT COMPLETED 5 5
Period Title: Main Study
STARTED 11 7
COMPLETED 11 7
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock With Feedback (Group A) Pilot:Insulclock Without Feedback (Group B) Total
Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
Overall Participants 40 40 11 7 98
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
35
87.5%
35
87.5%
11
100%
7
100%
88
89.8%
>=65 years
5
12.5%
5
12.5%
0
0%
0
0%
10
10.2%
Sex: Female, Male (Count of Participants)
Female
27
67.5%
17
42.5%
6
54.5%
3
42.9%
53
54.1%
Male
13
32.5%
23
57.5%
5
45.5%
4
57.1%
45
45.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
Black or African American
36
90%
37
92.5%
11
100%
6
85.7%
90
91.8%
White
1
2.5%
3
7.5%
0
0%
0
0%
4
4.1%
More than one race
0
0%
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
3
7.5%
0
0%
0
0%
1
14.3%
4
4.1%
Region of Enrollment (participants) [Number]
United States
40
100%
40
100%
11
100%
7
100%
98
100%

Outcome Measures

1. Primary Outcome
Title Number of Insulin Injection Irregularities.
Description 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.

Outcome Measure Data

Analysis Population Description
Data were collected as a part of main phase of the study only.
Arm/Group Title Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock With Feedback (Group A) Pilot: Insulclock Without Feedback (Group B)
Arm/Group Description 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. 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. 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. 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.
Measure Participants 40 40 0 0
Mean (Standard Deviation) [irregularities]
22.22
(25.12)
23.10
(26.75)
2. Primary Outcome
Title Number of Participants Experiencing Insulclock Device Malfunctions
Description Number of participants experiencing Insulclock device malfunctions are reported
Time Frame Up to 12 weeks

Outcome Measure Data

Analysis Population Description
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/Group Title Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock With Feedback (Group A) Pilot:Insulclock Without Feedback (Group B)
Arm/Group Description 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. 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. 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. 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.
Measure Participants 0 0 11 7
Count of Participants [Participants]
5
12.5%
2
5%
3. Secondary Outcome
Title Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score.
Description 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

Outcome Measure Data

Analysis Population Description
Data were collected as a part of main phase of the study only.
Arm/Group Title Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock Without Feedback (Group A) Pilot: Insulclock Without Feedback (Group B)
Arm/Group Description 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. 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. 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. 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.
Measure Participants 40 40 0 0
Mean (Standard Deviation) [score on a scale]
15.45
(3.7)
15.18
(3.05)
4. Secondary Outcome
Title Change in Diabetes Related Quality of Life (DRQoL) Scores.
Description 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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock Without Feedback (Group A) Pilot: Insulclock Without Feedback (Group B)
Arm/Group Description 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. 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. 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. 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.
Measure Participants 0 0 0 0
5. Secondary Outcome
Title Change in Mean HbA1c.
Description 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

Outcome Measure Data

Analysis Population Description
Data were collected as a part of main phase of the study only.
Arm/Group Title Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock Without Feedback (Group A) Pilot: Insulclock Without Feedback (Group B)
Arm/Group Description 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. 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. 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. 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.
Measure Participants 40 40 0 0
Mean (Standard Deviation) [mg/dL]
-0.9
(2.02)
-0.73
(2)
6. Secondary Outcome
Title Number of Episodes of Hypoglycemia.
Description 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.

Outcome Measure Data

Analysis Population Description
Data were collected as a part of main phase of the study only.
Arm/Group Title Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock Without Feedback (Group A) Pilot: Insulclock Without Feedback (Group B)
Arm/Group Description 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. 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. 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. 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.
Measure Participants 40 40 0 0
Number [number of events]
29
25
7. Secondary Outcome
Title Number of Episodes of Severe Hypoglycemia.
Description 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.

Outcome Measure Data

Analysis Population Description
Data were collected as a part of main phase of the study only.
Arm/Group Title Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock Without Feedback (Group A) Pilot: Insulclock Without Feedback (Group B)
Arm/Group Description 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. 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. 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. 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.
Measure Participants 40 40 0 0
Number [number of events]
1
1
8. Secondary Outcome
Title Change in Daily Fasting Glucose Profile Averages.
Description Daily fasting glucose profile averages will be recorded to monitor glycemic control.
Time Frame Week 0 through week 24.

Outcome Measure Data

Analysis Population Description
Data were collected as a part of main phase of the study only.
Arm/Group Title Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock Without Feedback (Group A) Pilot: Insulclock Without Feedback (Group B)
Arm/Group Description 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. 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. 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. 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.
Measure Participants 40 40 0 0
Mean (Standard Deviation) [mg/dL]
142.24
(32)
146.54
(39)
9. Secondary Outcome
Title Change in 7-point Self Monitoring of Blood Glucose (SMBG) Profile.
Description 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.

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock Without Feedback (Group A) Pilot: Insulclock Without Feedback (Group B)
Arm/Group Description 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. 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. 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. 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.
Measure Participants 0 0 0 0
10. Secondary Outcome
Title Change in Diabetes Quality of Life Clinical Trial Questionnaire-Revised (DQLCTQ-R) Score
Description 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.

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock Without Feedback (Group A) Pilot: Insulclock Without Feedback (Group B)
Arm/Group Description 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. 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. 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. 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.
Measure Participants 0 0 0 0

Adverse Events

Time Frame 24 weeks
Adverse Event Reporting Description
Arm/Group Title Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock With Feedback (Group A) Pilot: Insulclock Without Feedback (Group B)
Arm/Group Description 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. 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. 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. 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.
All Cause Mortality
Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock With Feedback (Group A) Pilot: Insulclock Without Feedback (Group B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/40 (0%) 0/40 (0%) 0/11 (0%) 0/7 (0%)
Serious Adverse Events
Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock With Feedback (Group A) Pilot: Insulclock Without Feedback (Group B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/40 (2.5%) 4/40 (10%) 0/11 (0%) 0/7 (0%)
Cardiac disorders
Heart Failure Readmission 0/40 (0%) 0 1/40 (2.5%) 2 0/11 (0%) 0 0/7 (0%) 0
Infections and infestations
Wound Infection 0/40 (0%) 0 1/40 (2.5%) 1 0/11 (0%) 0 0/7 (0%) 0
Surgical and medical procedures
Surgical Procedures 0/40 (0%) 0 2/40 (5%) 2 0/11 (0%) 0 0/7 (0%) 0
Vascular disorders
Stroke 1/40 (2.5%) 1 0/40 (0%) 0 0/11 (0%) 0 0/7 (0%) 0
Other (Not Including Serious) Adverse Events
Insulclock With Feedback (Group A) Insulclock Without Feedback (Group B) Pilot: Insulclock With Feedback (Group A) Pilot: Insulclock Without Feedback (Group B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 8/40 (20%) 13/40 (32.5%) 0/11 (0%) 0/7 (0%)
Cardiac disorders
CHF shortness of breath 0/40 (0%) 0 1/40 (2.5%) 1 0/11 (0%) 0 0/7 (0%) 0
Ear and labyrinth disorders
Ear infection 0/40 (0%) 0 1/40 (2.5%) 1 0/11 (0%) 0 0/7 (0%) 0
Endocrine disorders
Hyperglycemia 1/40 (2.5%) 1 0/40 (0%) 0 0/11 (0%) 0 0/7 (0%) 0
Hypoglicemia 2/40 (5%) 2 0/40 (0%) 0 0/11 (0%) 0 0/7 (0%) 0
Gastrointestinal disorders
Nausea and vomiting 1/40 (2.5%) 1 0/40 (0%) 0 0/11 (0%) 0 0/7 (0%) 0
Epigastric pain 1/40 (2.5%) 1 0/40 (0%) 0 0/11 (0%) 0 0/7 (0%) 0
General disorders
Pain 0/40 (0%) 0 1/40 (2.5%) 1 0/11 (0%) 0 0/7 (0%) 0
Leg swelling 0/40 (0%) 0 1/40 (2.5%) 1 0/11 (0%) 0 0/7 (0%) 0
Abdominal pain 0/40 (0%) 0 2/40 (5%) 2 0/11 (0%) 0 0/7 (0%) 0
Injury, poisoning and procedural complications
Non serious work related muscular injury 0/40 (0%) 0 1/40 (2.5%) 1 0/11 (0%) 0 0/7 (0%) 0
Musculoskeletal and connective tissue disorders
Back pain 1/40 (2.5%) 2 0/40 (0%) 0 0/11 (0%) 0 0/7 (0%) 0
Toe injury 1/40 (2.5%) 1 1/40 (2.5%) 1 0/11 (0%) 0 0/7 (0%) 0
Chest pain of muscular etiology 1/40 (2.5%) 1 2/40 (5%) 2 0/11 (0%) 0 0/7 (0%) 0
Nervous system disorders
Diabetic neuropathy 0/40 (0%) 0 1/40 (2.5%) 1 0/11 (0%) 0 0/7 (0%) 0
Respiratory, thoracic and mediastinal disorders
Asthma 0/40 (0%) 0 1/40 (2.5%) 1 0/11 (0%) 0 0/7 (0%) 0
Vascular disorders
Hypertension 0/40 (0%) 0 1/40 (2.5%) 1 0/11 (0%) 0 0/7 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Umpierrez
Organization Emory University
Phone 404-251-8957
Email geumpie@emory.edu
Responsible Party:
Guillermo Umpierrez, MD, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier:
NCT03224234
Other Study ID Numbers:
  • IRB00094393
First Posted:
Jul 21, 2017
Last Update Posted:
Jan 22, 2021
Last Verified:
Jan 1, 2021