Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration

• Sponsor: Joslin Diabetes Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01698528
• Collaborator: Massachusetts Institute of Technology (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if using a diabetes management technology system, including a tablet computer, to track diabetes care and communicate with a clinician coach (a doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology system with a clinician coach helps more individuals starting basal insulin achieve better glycemic control with less hypoglycemia compared with standard clinical practice at Joslin Diabetes Center.

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes	Device: Tablet Computer	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.	Device: Tablet Computer; Other Names: Toshiba tablet computer
No Intervention: Control Group The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.

Outcome Measures

Primary Outcome Measures

1. Glycemic Control as Determined by the Change in Absolute HbA1c Level [3 months]

   The primary outcome of interest is absolute decrease in A1c by end of 3 months.

Secondary Outcome Measures

1. Number of Participants Reaching Target of HbA1c ≤ 7% [3 months]

   Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.

2. Change in Average Participation Satisfaction [3 months]

   The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48, with higher scores indicating greater satisfaction. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.

3. Number of Participants With Hypoglycemia [3 months]

   Number of participants had hypoglycemia during the trial period

4. Time Health Care Providers and Subjects Spend on Managing the Insulin Titration [3 months]

   time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion:

• 18 years or older

• Has type 2 diabetes, starting on basal insulin therapy

• Hemoglobin A1c between 9-14%

• Has Wi-Fi internet connection at home

• Is willing to monitor blood glucose at least once per day

• Is willing to inject and self-titrate insulin dose

• Able to read and communicate in English proficiently

Exclusion:

• Has severe visual impairment impacting visual acuity

• Has severe hearing impairment impacting communication

• Has Type 1 diabetes

• Pregnant or lactating women

• Alcohol dependency

• Require multiple daily insulin injections

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joslin Diabetes Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Joslin Diabetes Center
• Massachusetts Institute of Technology

Investigators

• Principal Investigator: William Hsu, M.D., Joslin Diabetes Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joslin Diabetes Center
• ClinicalTrials.gov Identifier: NCT01698528
• Other Study ID Numbers: CHS 2012-18
• First Posted: Oct 3, 2012
• Last Update Posted: Oct 24, 2018
• Last Verified: Sep 1, 2018

• Keywords provided by Joslin Diabetes Center: Diabetes; diabetes technologies; telemedicine
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Period Title: Overall Study
STARTED	20	20
COMPLETED	19	16
NOT COMPLETED	1	4

Baseline Characteristics

Arm/Group Title	Intervention Group	Control Group	Total
Arm/Group Description	The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.8 (16.04)	53.3 (1.88)	53.52 (13.76)
Sex: Female, Male (Count of Participants)
Female	7 35%	7 35%	14 35%
Male	13 65%	13 65%	26 65%
Region of Enrollment (Count of Participants)
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Glycemic Control as Determined by the Change in Absolute HbA1c Level
Description	The primary outcome of interest is absolute decrease in A1c by end of 3 months.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Measure Participants	20	20
Mean (Standard Deviation) [Percent A1C]	-3.16 (1.54)	-2.00 (2.03)

2. Secondary Outcome

Title	Number of Participants Reaching Target of HbA1c ≤ 7%
Description	Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Measure Participants	20	20
Count of Participants [Participants]	8 40%	5 25%

3. Secondary Outcome

Title	Change in Average Participation Satisfaction
Description	The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48, with higher scores indicating greater satisfaction. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Measure Participants	20	20
Mean (Standard Deviation) [Scores on a scale]	10.1 (11.68)	2.05 (6.45)

4. Secondary Outcome

Title	Number of Participants With Hypoglycemia
Description	Number of participants had hypoglycemia during the trial period
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Measure Participants	20	20
Count of Participants [Participants]	3 15%	1 5%

5. Secondary Outcome

Title	Time Health Care Providers and Subjects Spend on Managing the Insulin Titration
Description	time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Measure Participants	20	20
Mean (Standard Deviation) [min]	108 (41)	80 (51)

Adverse Events

Arm/Group Title	Intervention Group		Control Group
Arm/Group Description	The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer		The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
All Cause Mortality
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (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.