Insulin Dosage Software Program for People With Type 1 and Type 2 Diabetes

• Sponsor: HealthPartners Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01170208
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), Hygieia, Inc (Industry), International Diabetes Center at Park Nicollet (Other)
• Enrollment: 46
• Location: 1
• Arms: 3
• Duration (Months): 9
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief Summary

The purpose of the study is to determine the effectiveness and safety of the computer software program in providing insulin dosage recommendations. Participation in the study for 60 research subjects will last for 16-weeks and includes 3-4 clinic visits and a series of weekly telephone calls from the study team (minimum of 12 calls). Participants will be provided with weekly Study Log Sheets to record their daily blood glucose readings, insulin doses, grams of carbohydrate eaten at each meal (if they have type-1 diabetes) and any changes in their health (e.g., hypoglycemic episodes, illnesses). Participants will fax or drop off a copy of the Study Log Sheet. This information will be entered by the IDC study team into the computer software program. The IDC study team will review the information from the software and, based on the IDC's study team approval, any insulin dose changes will be communicated back to the patient by phone or fax.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Insulin	Device: insulin dose software	N/A

Detailed Description

Hygieia, Inc. is developing a device intended for use by insulin-requiring patients with diabetes. It will be a pocket-sized, hand-held device, combining a glucose meter with software that analyzes blood glucose levels recorded in the device's memory, and periodically recommends modifications in insulin dosage. The already developed software algorithms are based on the way an endocrinologist evaluates and frequently adjusts insulin dosage in a patient with diabetes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label, Uncontrolled, Single-Arm, Single-Center, 16-Week Study Assessing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device Software in 3-Groups of Subjects With Diabetes
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Group I Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting and insulin dose software.	Device: insulin dose software; The rationale to conduct this study is that Hygieia hypothesizes the software will effectively and safely optimize glucose control in insulin-requiring patients with type-1 and type-2 diabetes. The software was designed to provide safe insulin dosage recommendations.; Other Names: blood glucose meter
Other: Group II Type 2 diabetes treated with basal-bolustherapy and insulin dose software.	Device: insulin dose software; The rationale to conduct this study is that Hygieia hypothesizes the software will effectively and safely optimize glucose control in insulin-requiring patients with type-1 and type-2 diabetes. The software was designed to provide safe insulin dosage recommendations.; Other Names: blood glucose meter
Other: Group III Type 2 diabetes treated with biphasic insulin and insulin dose software.	Device: insulin dose software; The rationale to conduct this study is that Hygieia hypothesizes the software will effectively and safely optimize glucose control in insulin-requiring patients with type-1 and type-2 diabetes. The software was designed to provide safe insulin dosage recommendations.; Other Names: blood glucose meter

Outcome Measures

Primary Outcome Measures

1. Change in Weekly Mean Blood Glucose From Week 4 to Week 16 [Twelve week period from week 4 to week 16]

Secondary Outcome Measures

1. Reduction in HbA1c. [Twelve week period from week 4 to week 16]

2. Reduction in Fructosamine. [12 week period from Week 4 to Week 16]

3. Incidence of Severe or Serious Hypoglycemia. [January 2011]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• GROUP I

• Have been clinically diagnosed with type-1 diabetes for at least 1-year

• Have an HgbA1c of 7.4% or higher

• Treated with short-acting insulin analog (i.e. HumaLog® Lispro, NovoLog® Aspart, Apidra® Glulisine) before each meal and only one injection of long-acting insulin analog Lantus® (Glargine), per day. Subjects must typically eat 3 meals per day. The total daily combined dose of the long-acting and short-acting insulin analogs must be 25 units or more. Patient must have been using the same insulin regimen for the previous 3-months

• Is currently using an insulin/carbohydrate ratio to decide how much short-acting insulin to take before meals and must be able to use the gram versus choice method of carbohydrate counting.

• GROUP II

• Have been clinically diagnosed with type-2 diabetes for at least 1-year

• Have an HgbA1c of 7.4% or higher

• Treated with short-acting insulin analog (i.e. HumaLog® Lispro, NovoLog® Aspart, Apidra® Glulisine) before each meal and only one injection of long-acting insulin analog Lantus® (Glargine) per day and. Subjects must typically eat 3 meals per day. The total daily combined dose of the long-acting and short-acting insulin analogs must be 25 units or more. Patient must have been using the same insulin regimen for the previous 3-months

• May be using other diabetes agent(s) at a stable dose for the last 3-months.

• GROUP III

• Have been clinically diagnosed with type-2 diabetes for at least 1-year

• Have an HgbA1c of 7.8% or higher

• Take twice daily biphasic Insulin (e.g. HumaLog® Mix 75/25, NovoLog® Mix 70/30) or premixed insulin (i.e. Humulin® 70/30, Novolin® 70/30, NPH/Regular insulin 70/30) with a total daily insulin dose of 25 units and have been using the same insulin regimen for the past 3-months

• May be using other diabetes agent(s) at a stable dose for the last 3-months.

Exclusion Criteria:

• Have a history of greater than 2 episodes of severe hypoglycemia in the past year, or have hypoglycemic unawareness when glucose levels are less than or equal to 50 mg/dl

• Have a significant physical, psychological, or cognitive impairment that would prohibit adherence to the protocol

• Have any severe cardiovascular disease including a history of congestive heart failure (New York Heart Association [NYHA] 3 or 4), unstable angina, myocardial infarction or stroke that occurred within the 6-months preceding enrollment

• Have known active anemia with a hemotocrit less than 25% in women or 30% in men

• Have known history of renal disease (e.g., serum creatinine level >2.0 mg/dl or eGFR < 30 ml/min)

• Have active cancer or cancer in the past 2-years (except non-melanoma skin cancer

• Have history of significant liver disease including cirrhosis or elevated liver enzymes (e.g., AST and ALT greater than 3 times the upper limit of normal values)

• Have a body mass index (BMI) > 45 kg/m2; and/or

• Are pregnant, plan to become pregnant during the study period, or are breastfeeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International Diabetes Center	Minneapolis	Minnesota	United States	55416

Sponsors and Collaborators

• HealthPartners Institute
• National Institutes of Health (NIH)
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Hygieia, Inc
• International Diabetes Center at Park Nicollet

Investigators

• Principal Investigator: Richard M Bergenstal, MD, International Diabetes Center at Park Nicollet
• Study Director: Eran Bashan, PhD, Hygieia, Inc

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Publication

Publications

• Bergenstal RM, Johnson M, Powers MA, Wynne A, Vlajnic A, Hollander P, Rendell M. Adjust to target in type 2 diabetes: comparison of a simple algorithm with carbohydrate counting for adjustment of mealtime insulin glulisine. Diabetes Care. 2008 Jul;31(7):1305-10. doi: 10.2337/dc07-2137. Epub 2008 Mar 25.
• Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86.
• Herman WH, Ilag LL, Johnson SL, Martin CL, Sinding J, Al Harthi A, Plunkett CD, LaPorte FB, Burke R, Brown MB, Halter JB, Raskin P. A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes. Diabetes Care. 2005 Jul;28(7):1568-73.

• Responsible Party: HealthPartners Institute
• ClinicalTrials.gov Identifier: NCT01170208
• Other Study ID Numbers: 03985-10-A; R41DK085974
• First Posted: Jul 27, 2010
• Last Update Posted: Jan 27, 2020
• Last Verified: Jan 1, 2014

• Keywords provided by HealthPartners Institute: insulin; dosage software
• Additional relevant MeSH terms: Diabetes Mellitus; Insulin

Study Results

Participant Flow

Recruitment Details	July 2010 to October 2010. Location: Medical Clinic

Arm/Group Title	Group I	Group II	Group III
Arm/Group Description	Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting	Type 2 diabetes treated with basalbolus therapy	Type 2 diabetes treated with biphasic insulin.
Period Title: Overall Study
STARTED	20	20	6
COMPLETED	14	20	4
NOT COMPLETED	6	0	2

Baseline Characteristics

Arm/Group Title	Group I	Group II	Group III	Total
Arm/Group Description	Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting	Type 2 diabetes treated with basalbolus therapy	Type 2 diabetes treated with biphasic insulin.	Total of all reporting groups
Overall Participants	20	20	6	46
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	20 100%	13 65%	5 83.3%	38 82.6%
>=65 years	0 0%	7 35%	1 16.7%	8 17.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44 (12)	60 (7)	55 (7)	52 (12)
Sex: Female, Male (Count of Participants)
Female	13 65%	10 50%	4 66.7%	27 58.7%
Male	7 35%	10 50%	2 33.3%	19 41.3%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	6 100%	46 100%
Weekly Mean Blood Glucose (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	176.9 (28.3)	164.9 (37.6)	190.8 (47.0)	172.4 (35.0)
HbA1c (percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent]	8.4 (0.6)	8.3 (0.8)	9.1 (1.5)	8.4 (0.8)
Fructosamine (µM) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µM]	349 (46)	273 (30)	270 (33)	303 (53)

Outcome Measures

1. Primary Outcome

Title	Change in Weekly Mean Blood Glucose From Week 4 to Week 16
Time Frame	Twelve week period from week 4 to week 16

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Group I	Group II	Group III
Arm/Group Description	Type 1 diabetes treated with basal-bolus insulin the	Type 2 diabetes treated with basal bolus therapy	Type 2 diabetes treated with biphasic insulin
Measure Participants	14	20	4
Mean (Standard Deviation) [mg/dL]	4.6 (29.3)	8.1 (51.0)	29.5 (17.1)

2. Secondary Outcome

Title	Reduction in HbA1c.
Time Frame	Twelve week period from week 4 to week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I	Group II	Group III
Arm/Group Description	Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting	Type 2 diabetes treated with basalbolus therapy	Type 2 diabetes treated with biphasic insulin.
Measure Participants	20	20	6
Mean (Standard Deviation) [percentage of A1c]	0.1 (0.8)	0.6 (0.9)	1.3 (1.4)

3. Secondary Outcome

Title	Reduction in Fructosamine.
Time Frame	12 week period from Week 4 to Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I	Group II	Group III
Arm/Group Description	Type 1 diabetes treated with basal-bolus insulin the	Type 2 diabetes treated with basal bolus therapy	Type 2 diabetes treated with biphasic insulin
Measure Participants	20	20	6
Mean (Standard Deviation) [µM]	-4.2 (29.2)	10.2 (32.2)	37.0 (20.9)

4. Secondary Outcome

Title	Incidence of Severe or Serious Hypoglycemia.
Time Frame	January 2011

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I	Group II	Group III
Arm/Group Description	Type 1 diabetes treated with basal-bolus insulin the	Type 2 diabetes treated with basal bolus therapy	Type 2 diabetes treated with biphasic insulin
Measure Participants	20	20	6
Count of Participants [Participants]	0 0%	0 0%	0 0%

Adverse Events

Arm/Group Title	Group I		Group II		Group III
Arm/Group Description	Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting		Type 2 diabetes treated with basalbolus therapy		Type 2 diabetes treated with biphasic insulin.
All Cause Mortality
	Group I		Group II		Group III
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Group I		Group II		Group III
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Group I		Group II		Group III
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/6 (0%)

Limitations/Caveats

Study was limited by lack of a control group.

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.